CIPN - Chemotherapy-Induced Peripheral NeuropathyCIPNNCT03348956

Biomarkers in Chemotherapy-Induced Peripheral Neurotoxicity

A study testing EPR Oximetry in people with CIPN - Chemotherapy-Induced Peripheral Neuropathy, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: CIPN - Chemotherapy-Induced Peripheral Neuropathy
What is being tested?: EPR Oximetry
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 7 participants
Where: 1 siteUnited States
Study dates: 1 Mar 2018to 14 Feb 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Scheduled to receive chemotherapy with taxane compounds for the treatment of breast cancer.
No prior taxane or platinum chemotherapy prior to enrollment.
Life expectancy greater than or equal to 12 months.
Able to provide independent informed consent for the study.
Able to undergo EPR oximetry
Age 18 years or older

Who cannot join

Central nervous system or other impairments that interfere with clinical and electrophysiological assessment.
Unable to provide independent informed consent.
Pacemaker or other metallic objects that would be contraindicated for MRI.
A requirement for supplemental oxygen at baseline, or known, severe chronic obstructive pulmonary disease .
Previous exposure to neurotoxic chemotherapeutic agents.

Trial locations and contacts

1 site in 1 country.

United States1 site

Dartmouth-Hitchcock Medical Center in Lebanon, NH
Lebanon, New Hampshire, 03766

Other trials in United States

About this study

Official title: Biomarkers in Chemotherapy-Induced Peripheral Neurotoxicity: Better Tools and Understanding

This pilot study will attempt to establish the feasibility of using tissue oxygen measurements and the protein, neurofilament light chain (NF-L), as potential biomarkers for chemotherapy-induced peripheral neuropathy (CIPN). Thirty (30) subjects scheduled to begin taxane-based chemotherapy for breast tumor will be assigned to receive an India ink injection under the skin of the foot. The ink will be used to make up to five (5) 45-minute "electron paramagnetic resonance" (EPR) oximetry readings prior to the start of chemotherapy. Subjects will undergo electrophysiologic assessments including nerve conduction studies, in addition to a neurological examination prior to the start of chemotherapy. Subjects will have the EPR oximetry readings, electrophysiologic tests, and neurological examination two more times: at the halfway point of their chemotherapy treatment -- or at the onset of CIPN symptoms -- and again after chemotherapy has been completed. Subjects will also have blood drawn prior to beginning taxane-based chemotherapy, prior to every scheduled chemotherapy treatment, and after completion of chemotherapy in order to test for neurofilament light chain (NF-L).

Read the detailed description

Therapy with chemotherapeutic drugs can make a huge impact on survival and quality of life in patients with cancer. Advances in medical monitoring and the effectiveness of these therapies have significantly improved outcomes so that a definitive cure or long-term survival is more likely. Cancer survivors are used to dealing with serious side effects of their therapy; however, some of the side effects from the chemotherapy drugs persist even after the medication course is completed. The impact of these sequelae on quality of survival is increasingly being appreciated and forming an important new direction of cancer care. One of the more severe side effects of chemotherapy is peripheral neurotoxicity resulting in neuropathy or neuronopathy.

Chemotherapy-induced peripheral neurotoxicity (CIPN) is one of the least predictable and most prolonged sequelae with effects ranging from pain, numbness and tingling to diffuse weakness sometimes to the extent of paralysis. It results from damage or alteration in function of peripheral nerves usually, but not always, in a length-dependent manner. An indirect impact of CIPN includes difficulties with balance and susceptibility to falls. There are currently no therapies that have been proven to prevent CIPN. Similarly, there are few medications that are known to be effective in the reversing CIPN once it develops or effectively treating symptoms of CIPN. Currently, diagnosis is based mainly on clinical examination and electrophysiological testing to monitor CIPN; identification of candidate biomarkers through which disease onset can be identified at an earlier stage and which reflect presumed pathophysiologic mechanisms is of paramount importance.

There are different theories of CIPN pathogenesis. One of the leading hypotheses relates to mitochondrial dysfunction and oxidative stress affecting both the dorsal root ganglia neurons and supportive endothelial cells of the vasa nervorum. Here at Dartmouth, a specialized technique has been developed that allows the non-invasive assessment of tissue oxygen in and around peripheral nerve. This technique, called "electron paramagnetic resonance" (EPR) oximetry, allows for repeated measurements over time that can be correlated with other metrics of peripheral nerve function. Given its relevance to an important pathophysiologic mechanism of disease, EPR oximetry may provide an early marker of disease onset.

Neurofilament light chain (NF-L) is also emerging as a sensitive blood-based biomarker of axonal degeneration. NF-L is a component of the axonal cytoskeleton that leaks out of degenerating axons. NF-L has been reported to be elevated in plasma or serum in a wide range of neurodegenerative disorders, including CNS disorders such as multiple sclerosis and ALS as well as PNS disorders such as Charcot Marie Tooth and Guillain-Barre syndrome. To date, there are no published reports of elevated blood NF-L levels in patients with CIPN, although it has been reported to increase in rat model of vincristine-induced neuropathy.

In this proposal, the investigators will be testing the hypothesis that these could both be biomarkers of CIPN. It is hoped that the oximetry measurement and blood NF-L levels will (i) reflect the changes that occur on a cellular level and the damaged nerves, (ii) reflect the damage occurring to nerves more sensitively than existing techniques, and (iii) help to better understand the reason the nerves are being damaged. It is also hoped that these will be something that can be used in future clinical trials.

Conditions: CIPN - Chemotherapy-Induced Peripheral Neuropathy
Being tested: EPR Oximetry

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EPR OximetryDiagnostic test
Subjects will have up to five EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.

Study groups in NCT03348956
Study group	Role	What they receive
EPR Oximetry	Experimental	All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points (pre-exposure, during-exposure or CIPN incidence, and post exposure), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing. Receives: Diagnostic Test: EPR Oximetry

What is being measured

The primary outcome is the main question the study is designed to answer.

Relative Change in % pO2
EPR Oximetry will measure tissue oxygen levels in the injected foot during 10 minutes of breathing room air, 10 minutes while breathing 100% oxygen, and 10 minutes of room air.
Measured: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)

Secondary outcomes (44)

Neurologic Examination_ Strength_ Toe Fan
Patients will be phenotyped by a neurologic examination before and after exposure to a standard regimen of neurotoxic chemotherapy.
MRC scale for muscle strength (0-5) Grade 5: Normal Grade 4: Movement against gravity and resistance Grade 3: Movement against gravity over (almost) the full range Grade 2: Movement of the limb but not against gravity Grade 1: Visible contraction without movement of the limb (not existent for hip flexion) Grade 0: No visible contraction
Measured: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Neurologic Examination_ Strength_ Toe Flex
Patients will be phenotyped by a neurologic examination before and after exposure to a standard regimen of neurotoxic chemotherapy.
MRC scale for muscle strength (0-5) Grade 5: Normal Grade 4: Movement against gravity and resistance Grade 3: Movement against gravity over (almost) the full range Grade 2: Movement of the limb but not against gravity Grade 1: Visible contraction without movement of the limb (not existent for hip flexion) Grade 0: No visible contraction
Measured: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Neurologic Examination_ Strength_ Inv
Patients will be phenotyped by a neurologic examination before and after exposure to a standard regimen of neurotoxic chemotherapy.
MRC scale for muscle strength (0-5) Grade 5: Normal Grade 4: Movement against gravity and resistance Grade 3: Movement against gravity over (almost) the full range Grade 2: Movement of the limb but not against gravity Grade 1: Visible contraction without movement of the limb (not existent for hip flexion) Grade 0: No visible contraction
Measured: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Neurologic Examination_ Strength_ Ev
Patients will be phenotyped by a neurologic examination before and after exposure to a standard regimen of neurotoxic chemotherapy.
MRC scale for muscle strength (0-5) Grade 5: Normal Grade 4: Movement against gravity and resistance Grade 3: Movement against gravity over (almost) the full range Grade 2: Movement of the limb but not against gravity Grade 1: Visible contraction without movement of the limb (not existent for hip flexion) Grade 0: No visible contraction
Measured: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Neurologic Examination_ Strength_ ADF
Patients will be phenotyped by a neurologic examination before and after exposure to a standard regimen of neurotoxic chemotherapy.
MRC scale for muscle strength (0-5) Grade 5: Normal Grade 4: Movement against gravity and resistance Grade 3: Movement against gravity over (almost) the full range Grade 2: Movement of the limb but not against gravity Grade 1: Visible contraction without movement of the limb (not existent for hip flexion) Grade 0: No visible contraction
Measured: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Neurologic Examination_ Vibration Sense_Toe
Patients will be phenotyped by a neurologic examination before and after exposure to a standard regimen of neurotoxic chemotherapy.
The position of the intersect is recorded on an arbitrary scale from 0 to 8 on a Rydel-Seiffer tuning fork once the subject is no longer perceiving vibration.
The higher the number, the better the vibratory sense.
Measured: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Neurologic Examination_ Vibration Sense_MM
Patients will be phenotyped by a neurologic examination before and after exposure to a standard regimen of neurotoxic chemotherapy.
The position of the intersect is recorded on an arbitrary scale from 0 to 8 on a Rydel-Seiffer tuning fork once the subject is no longer perceiving vibration.
The higher the number, the better the vibratory sense.
Measured: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Neurologic Examination_ Vibration Sense_Knee
Patients will be phenotyped by a neurologic examination before and after exposure to a standard regimen of neurotoxic chemotherapy.
The position of the intersect is recorded on an arbitrary scale from 0 to 8 on a Rydel-Seiffer tuning fork once the subject is no longer perceiving vibration.
The higher the number, the better the vibratory sense.
Measured: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Neurologic Examination_ Vibration Sense_DIP2
Patients will be phenotyped by a neurologic examination before and after exposure to a standard regimen of neurotoxic chemotherapy.
The position of the intersect is recorded on an arbitrary scale from 0 to 8 on a Rydel-Seiffer tuning fork once the subject is no longer perceiving vibration.
The higher the number, the better the vibratory sense.
Measured: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Neurologic Examination_ Vibration Sense_DIP5
Patients will be phenotyped by a neurologic examination before and after exposure to a standard regimen of neurotoxic chemotherapy.
The position of the intersect is recorded on an arbitrary scale from 0 to 8 on a Rydel-Seiffer tuning fork once the subject is no longer perceiving vibration.
The higher the number, the better the vibratory sense.
Measured: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Neurologic Examination_ Deep Tendon Reflexes _ Biceps
Patients will be phenotyped by a neurologic examination before and after exposure to a standard regimen of neurotoxic chemotherapy.
REFLEX SCALE for Deep Tendon Reflexes (DTRs)
The score ranges from 0 - 9, where 0 is no reflex response (areflexia)/always abnormal, greater than 1 and less than 3 is normal, and 9 is a tap that elicits a repeating reflex (clonus)/always abnormal.
Measured: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Neurologic Examination_ Deep Tendon Reflexes _ Triceps
Patients will be phenotyped by a neurologic examination before and after exposure to a standard regimen of neurotoxic chemotherapy.
REFLEX SCALE for Deep Tendon Reflexes (DTRs)
The score ranges from 0 - 9, where 0 is no reflex response (areflexia)/always abnormal, greater than 1 and less than 3 is normal, and 9 is a tap that elicits a repeating reflex (clonus)/always abnormal.
Measured: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Neurologic Examination_ Deep Tendon Reflexes _ BR
Patients will be phenotyped by a neurologic examination before and after exposure to a standard regimen of neurotoxic chemotherapy.
REFLEX SCALE for Deep Tendon Reflexes (DTRs)
The score ranges from 0 - 9, where 0 is no reflex response (areflexia)/always abnormal, greater than 1 and less than 3 is normal, and 9 is a tap that elicits a repeating reflex (clonus)/always abnormal.
Measured: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Neurologic Examination_ Deep Tendon Reflexes _ Patella
Patients will be phenotyped by a neurologic examination before and after exposure to a standard regimen of neurotoxic chemotherapy.
REFLEX SCALE for Deep Tendon Reflexes (DTRs)
The score ranges from 0 - 9, where 0 is no reflex response (areflexia)/always abnormal, greater than 1 and less than 3 is normal, and 9 is a tap that elicits a repeating reflex (clonus)/always abnormal.
Measured: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Neurologic Examination_ Deep Tendon Reflexes _ Achilles
Patients will be phenotyped by a neurologic examination before and after exposure to a standard regimen of neurotoxic chemotherapy.
REFLEX SCALE for Deep Tendon Reflexes (DTRs)
The score ranges from 0 - 9, where 0 is no reflex response (areflexia)/always abnormal, greater than 1 and less than 3 is normal, and 9 is a tap that elicits a repeating reflex (clonus)/always abnormal.
Measured: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Mean Nerve Conduction Metrics (Amplitude)_DORSAL SURAL
Electrophysiologic testing will measure nerve conduction amplitude in patients before and after exposure to a standard regimen of neurotoxic chemotherapy.
Measured: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Change in Nerve Conduction Metrics (Amplitude)_MED PLANTAR
Electrophysiologic testing will measure nerve conduction amplitude in patients before and after exposure to a standard regimen of neurotoxic chemotherapy.
Measured: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Change in Nerve Conduction Metrics (Amplitude)_SURAL
Electrophysiologic testing will measure nerve conduction amplitude in patients before and after exposure to a standard regimen of neurotoxic chemotherapy.
Measured: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Mean of the Difference in Nerve Conduction Amplitudes Between Pre-Mid and Pre-Post exposure_Dorsal Sural
Electrophysiologic testing will measure nerve conduction amplitude in patients before and after exposure to a standard regimen of neurotoxic chemotherapy. The outcome measure is reporting the average of the differences in amplitudes Pre-Mid and Pre-Post exposure (for example, the change from Pre and Mid is calculated, and then the change across all participants is averaged).
Measured: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Change in Nerve Conduction/Mixed Nerve Amplitudes _Medial Plantar
Electrophysiologic testing will measure nerve conduction amplitude in patients before and after exposure to a standard regimen of neurotoxic chemotherapy.
Measured: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Change in Nerve Conduction/Mixed Nerve Amplitudes _Sural
Electrophysiologic testing will measure nerve conduction amplitude in patients before and after exposure to a standard regimen of neurotoxic chemotherapy.
Measured: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Change in Nerve Conduction_Motor_ (Amplitude)_Peron-EDB
Electrophysiologic testing will measure nerve conduction amplitude in patients before and after exposure to a standard regimen of neurotoxic chemotherapy.
Measured: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Change in Nerve Conduction_Motor_ (Amplitude)_Peron-TA
Electrophysiologic testing will measure nerve conduction amplitude in patients before and after exposure to a standard regimen of neurotoxic chemotherapy.
Measured: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Change in Nerve Conduction_Motor_ (Amplitude)_Tibial-AH
Electrophysiologic testing will measure nerve conduction amplitude in patients before and after exposure to a standard regimen of neurotoxic chemotherapy.
Measured: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Nerve Conduction Metrics as Measured by Mean Change (Velocity) for Peroneal CMAP AMP, EDB
Electrophysiologic testing will measure nerve conduction velocity in patients before and after exposure to a standard regimen of neurotoxic chemotherapy.
Measured: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Nerve Conduction Metrics as Measured by Mean Change (Velocity) for Peroneal CMAP, AT
Electrophysiologic testing will measure nerve conduction velocity in patients before and after exposure to a standard regimen of neurotoxic chemotherapy.
Measured: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Nerve Conduction Metrics as Measured by Mean Change (Velocity) for Tibial CMAP, AH
Electrophysiologic testing will measure nerve conduction velocity in patients before and after exposure to a standard regimen of neurotoxic chemotherapy.
Measured: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Nerve Conduction Metrics as Measured by Mean Change (Velocity) for Dorsal Sural CV
Electrophysiologic testing will measure nerve conduction velocity in patients before and after exposure to a standard regimen of neurotoxic chemotherapy.
Measured: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Nerve Conduction Metrics as Measured by Mean Change (Velocity) for Med Plantar CV
Electrophysiologic testing will measure nerve conduction velocity in patients before and after exposure to a standard regimen of neurotoxic chemotherapy.
Measured: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Nerve Conduction Metrics as Measured by Mean Change (Velocity) for Sural CV
Electrophysiologic testing will measure nerve conduction velocity in patients before and after exposure to a standard regimen of neurotoxic chemotherapy.
Measured: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Nerve Conduction Metrics as Measured by Mean Change (Velocity) for Peroneal CV, Distal
Electrophysiologic testing will measure nerve conduction velocity in patients before and after exposure to a standard regimen of neurotoxic chemotherapy.
Measured: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Mean Score of Neuro-Quality of Life - Positive Affect and Well-Being Scale
Neuropathy-Specific Quality of Life scale measuring Positive Affect and Well Being
The range in score is 23 to 115, with a low score indicating a less positive affect and well-being
Measured: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Mean Score of Neuro-Quality of Life - Satisfaction With Social Roles and Activities Scale
Neuropathy-Specific Quality of Life scale measuring Satisfaction with Social Roles and Activities
The range in scores is 47 to 235, with a lower score indicating less satisfaction with social roles and activities
Measured: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Mean Score of Neuro-Quality of Life - Lower Extremity Function (Mobility) Scale
Neuropathy-Specific Quality of Life scale measuring Lower Extremity Function (Mobility)
The range in scores is 19 to 95, with a lower score indicating more difficulty with lower extremity function
Measured: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Mean Score of Neuro-Quality of Life - Upper Extremity Function (Fine Motor, Activities of Daily Living) Scale
Neuropathy-Specific Quality of Life scale measuring Upper Extremity Function (Fine Motor, Activities of Daily Living)
The range in scores is 20 to 100, with a low score indicating more difficulty with upper extremity function
Measured: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Mean Score of The Neuropathy Total Symptom Score-6 Questionnaire
Neuropathy Total Symptom Score questionnaire with 6 questions
The range is scores is 0 to 22 with a higher score indicating worse symptoms
Measured: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Mean Score of Toronto Clinical Neuropathy Scoring System
Toronto Clinical Neuropathy Scoring System
The range in scores is 0 to 19 with higher scores indicating worse neuropathy
Measured: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Mean Score of National Cancer Institute - Common Toxicity Criteria
National Cancer Insitute - Common Toxicity Criteria
The range in scores is 0 to 5, with higher scores indicating worse toxicity
Measured: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Mean Score of Total Neuropathy Scores
Total Neuropathy score
The range in scores is 0 to 40, with higher scores indicating worse neuropathy
Measured: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Mean Score of Survey of Autonomic Symptoms, Column B
Survey of Autonomic Symptoms, questions in Column B
The range in scores is 0 to 55 for women and 0 to 60 for men, with higher scores indicating more bothersome symptoms
Measured: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Mean Score of McGill Pain Visual Analog Scale
McGill Visual Analog Scale for Pain
The range in scores is 0 to 100, with 0 indicting "No pain" and 100 indicating "Worst pain possible"
Measured: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Mean Scores of Short Form McGill Pain Questionnaire
Short Form McGill Pain Questionnaire
The range in scores is 0 to 15, with higher scores indicating worse pain
Measured: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Mean Score of Survey of Autonomic Symptoms, Column A
Survey of Autonomic Symptoms, questions in column A
The range in scores is 0 to 11 for women and 0 to 12 for men, with higher scores indicating more symptoms
Measured: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Serum NF-L Levels
Changes in serum NFL levels over the course of chemotherapy will be monitored to determine if NFL can be used as a biomarker for axonal damage in patients who develop CIPN. NFL will be measured at baseline, before each round of chemotherapy and at the completion of chemotherapy. Changes in NFL will be compared between patients who develop CIPN and those that do not.
Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 201814 Feb 2022

First posted21 Nov 2017
Study start1 Mar 2018
Primary completion14 Feb 2022
Study completion14 Feb 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for CIPN - Chemotherapy-Induced Peripheral NeuropathyStudies of the same condition, open and under way.
More trials run by Dartmouth-Hitchcock Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 7 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03348956
Sponsor's protocol ID: D17062
Acronym: CIPN
Status last verified: May 2024
First submitted: 19 Oct 2017
Last updated: 20 Jun 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No: Individual participant data is not intended to be shared with other researchers per the current protocol and informed consent.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
The AIUR Trial: Surgical Gloves to Prevent Peripheral Neuropathy
Chemotherapy-induced Peripheral Neuropathy
Not yet recruiting
Continuous Controlled Cooling for Prevention of Chemotherapy-Induced Peripheral Neuropathy
Chemotherapy Induced Peripheral Neuropathy (CIPN)
RecruitingObservational study
Relationship Between Great Toe Strength And Symptoms of Chemotherapy-Induced Peripheral Neuropathy (CIPN)
Chemotherapy-induced Peripheral Neuropathy (CIPN), Healthy
Not yet recruiting
The Effect of Aerobic and Resistance Training With and Without Neurodynamic Exercises on Chemotherapy-induced Peripheral Neuropathy Symptoms and Associated Neuro-immune Mechanisms
Chemotherapy Induced Peripheral Neuropathy (CIPN)
RecruitingPhase 2
Analgesic Efficacy and Safety of Topical VMD-3866 Gel in Management of Pain Induced by Chemotherapy (CIPN)
Chemotherapy-induced Peripheral Neuropathy, Chemotherapy-induced Neuropathic Pain

All CIPN - Chemotherapy-Induced Peripheral Neuropathy trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Biomarkers in Chemotherapy-Induced Peripheral Neurotoxicity: Better Tools and Understanding
ClinicalTrials.gov ID: NCT03348956
Acronym / sponsor ID: CIPN / D17062
Conditions: CIPN - Chemotherapy-Induced Peripheral Neuropathy
Study type: Interventional
Recruitment status: Completed
Enrolment: 7 participants (actual)
Lead sponsor: Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
Collaborators: Disarm Therapeutics
Study start: 1 Mar 2018 (actual)
Primary completion: 14 Feb 2022 (actual)
Study completion: 14 Feb 2022 (actual)
First posted: 21 Nov 2017 (actual)
Results: Posted 20 Jun 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
EPR Oximetry	Experimental	Diagnostic Test: EPR OximetryAll subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points (pre-exposure, during-exposure or CIPN incidence, and post exposure), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Scheduled to receive chemotherapy with taxane compounds for the treatment of breast cancer.
No prior taxane or platinum chemotherapy prior to enrollment.
Life expectancy greater than or equal to 12 months.
Able to provide independent informed consent for the study.
Able to undergo EPR oximetry

Key exclusion criteria (5 listed)

Central nervous system or other impairments that interfere with clinical and electrophysiological assessment.
Unable to provide independent informed consent.
Pacemaker or other metallic objects that would be contraindicated for MRI.
A requirement for supplemental oxygen at baseline, or known, severe chronic obstructive pulmonary disease .
Previous exposure to neurotoxic chemotherapeutic agents.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
EPR OximetrySubjects will have up to five EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.	Diagnostic test	EPR Oximetry

Primary outcome

Relative Change in % pO2
Time frame: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
EPR Oximetry will measure tissue oxygen levels in the injected foot during 10 minutes of breathing room air, 10 minutes while breathing 100% oxygen, and 10 minutes of room air.

44 secondary outcomes

Neurologic Examination_ Strength_ Toe Fan
Time frame: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Neurologic Examination_ Strength_ Toe Flex
Time frame: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Neurologic Examination_ Strength_ Inv
Time frame: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Neurologic Examination_ Strength_ Ev
Time frame: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Neurologic Examination_ Strength_ ADF
Time frame: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Neurologic Examination_ Vibration Sense_Toe
Time frame: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Neurologic Examination_ Vibration Sense_MM
Time frame: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Neurologic Examination_ Vibration Sense_Knee
Time frame: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Neurologic Examination_ Vibration Sense_DIP2
Time frame: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Neurologic Examination_ Vibration Sense_DIP5
Time frame: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Neurologic Examination_ Deep Tendon Reflexes _ Biceps
Time frame: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Neurologic Examination_ Deep Tendon Reflexes _ Triceps
Time frame: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Neurologic Examination_ Deep Tendon Reflexes _ BR
Time frame: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Neurologic Examination_ Deep Tendon Reflexes _ Patella
Time frame: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Neurologic Examination_ Deep Tendon Reflexes _ Achilles
Time frame: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Mean Nerve Conduction Metrics (Amplitude)_DORSAL SURAL
Time frame: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Change in Nerve Conduction Metrics (Amplitude)_MED PLANTAR
Time frame: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Change in Nerve Conduction Metrics (Amplitude)_SURAL
Time frame: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Mean of the Difference in Nerve Conduction Amplitudes Between Pre-Mid and Pre-Post exposure_Dorsal Sural
Time frame: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Change in Nerve Conduction/Mixed Nerve Amplitudes _Medial Plantar
Time frame: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Change in Nerve Conduction/Mixed Nerve Amplitudes _Sural
Time frame: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Change in Nerve Conduction_Motor_ (Amplitude)_Peron-EDB
Time frame: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Change in Nerve Conduction_Motor_ (Amplitude)_Peron-TA
Time frame: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Change in Nerve Conduction_Motor_ (Amplitude)_Tibial-AH
Time frame: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Nerve Conduction Metrics as Measured by Mean Change (Velocity) for Peroneal CMAP AMP, EDB
Time frame: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Nerve Conduction Metrics as Measured by Mean Change (Velocity) for Peroneal CMAP, AT
Time frame: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Nerve Conduction Metrics as Measured by Mean Change (Velocity) for Tibial CMAP, AH
Time frame: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Nerve Conduction Metrics as Measured by Mean Change (Velocity) for Dorsal Sural CV
Time frame: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Nerve Conduction Metrics as Measured by Mean Change (Velocity) for Med Plantar CV
Time frame: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Nerve Conduction Metrics as Measured by Mean Change (Velocity) for Sural CV
Time frame: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Nerve Conduction Metrics as Measured by Mean Change (Velocity) for Peroneal CV, Distal
Time frame: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Mean Score of Neuro-Quality of Life - Positive Affect and Well-Being Scale
Time frame: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Mean Score of Neuro-Quality of Life - Satisfaction With Social Roles and Activities Scale
Time frame: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Mean Score of Neuro-Quality of Life - Lower Extremity Function (Mobility) Scale
Time frame: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Mean Score of Neuro-Quality of Life - Upper Extremity Function (Fine Motor, Activities of Daily Living) Scale
Time frame: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Mean Score of The Neuropathy Total Symptom Score-6 Questionnaire
Time frame: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Mean Score of Toronto Clinical Neuropathy Scoring System
Time frame: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Mean Score of National Cancer Institute - Common Toxicity Criteria
Time frame: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Mean Score of Total Neuropathy Scores
Time frame: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
Mean Score of Survey of Autonomic Symptoms, Column B
Time frame: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)

Results and safety

Results posted to the registry on 20 Jun 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
EPR Oximetry	7	3

Primary outcome: Relative Change in % pO2

Time frame: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline). Mean (Full Range). Unit: change in % oxygenation

Measure	Relative % pO2 Change From Baseline While Breathing Room Air n = 3	Relative % pO2 Change From Baseline While Breathing 100% Oxygen n = 3	Relative % pO2 Change From Baseline While Breathing Room Air (Recovery) n = 3
Mid-Point	12.3 (-7 to 45)	19 (-25 to 44)	24 (11 to 44)
End of Chemo	25.3 (20 to 32)	9.5 (4 to 15)	42.5 (39 to 46)

Population analysed: 3 patients underwent testing. 1 patient did not undergo the 100% oxygen condition at the End of Chemo, so there is no data for Mid-Point or recovery for that patient. Data was not gathered for the remaining 4 participants.

44 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events will be reported from the initiation of any study procedures to the end of the study treatment follow-up. Adverse events were collected from Baseline through 15 - 18 weeks after chemotherapy.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
EPR Oximetry	0 of 7 (0%)	6 of 7 (85.7%)	0 of 7

Limitations and caveats (from the sponsor): LIMITATION OF EPR DATA While it may be feasible to make serial measurements with the technique, there were technical problems with the sensor (India Ink), and no conclusions can be drawn in regard to oxygenation. Additionally, the ERP data are limited.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. Individual participant data is not intended to be shared with other researchers per the current protocol and informed consent.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Victoria H Lawson, M.D. principal investigator

Dartmouth-Hitchcock Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing EPR Oximetry in people with CIPN - Chemotherapy-Induced Peripheral Neuropathy, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Relative Change in % pO2 (time frame: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03348956.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2024.