Chemotherapy-Induced Peripheral NeuropathyNCT04367480
Effects of Transcutaneous Electrical Nerve Stimulation on Chemotherapy-Induced Peripheral Neuropathy
A study testing Questionnaire Administration and Transcutaneous Electrical Nerve Stimulation in people with Chemotherapy-Induced Peripheral Neuropathy, run by University of Rochester NCORP Research Base at 15 sites in United States.
Trial summary
This phase II trial studies the effects of transcutaneous electrical nerve stimulation (TENS) for the treatment of peripheral neuropathy caused by chemotherapy, often called chemotherapy-induced peripheral neuropathy (CIPN). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy-Induced Peripheral Neuropathy
- What is being tested?
- Questionnaire Administration and Transcutaneous Electrical Nerve Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 151 participants
- Where
- 15 sitesUnited States
- Study dates
- 10 Sep 2020to 3 Oct 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
- Have completed treatment with a platinum agent, taxane, vinca alkaloid, or bortezomib at least 3 months prior to registration
- Have a clinical diagnosis of CIPN from their physician or physician designee based on the following criteria: bilateral (i.e., present on both sides of the body), abnormal sensory symptoms in their feet or legs (e.g., hot/burning pain, sharp/shooting pain, numbness, tingling, cramping)
- Report at least 1 non-painful symptom associated with CIPN in their lower limbs (e.g., tingling, burning that isn't reported as painful, numbness)
- Report at least 2 of the following symptoms in their lower limbs (at their worst) as at least 4 out of 10 on a 0 - 10 NRS: hot/burning pain, sharp/shooting pain, numbness, tingling, cramping at visit 1 (i.e., week -1). Use the CIPN Symptom Inventory - week recall form (questions 1-5 ONLY) to assess these symptoms at screening
- Be willing and able not to start any new analgesic medications or change the dosages of any current analgesic medications (except acetaminophen [Tylenol] or non-steroidal anti-inflammatory drugs [NSAIDs] [i.e., ibuprofen (Advil, Motrin), naproxen (Aleve)]) for the duration of the study
- Be able to read English (i.e., is not illiterate, can speak English, and is not blind)
- Have access to a smart phone or device with an Apple or Android operating system that can be used to access the TENS device's application (App) and ability to connect to the internet on a daily basis during the trial
Who cannot join
- Have pre-existing neuropathy of any cause documented in their medical record prior to the start of chemotherapy or respond "yes" to the question "Did you have frequent numbness, tingling, sharp/shooting pain, hot/burning pain, or cramping in your feet before you started your chemotherapy?"
- Have unilateral CIPN symptoms (i.e., symptoms occur on predominantly only one side of the body)
- Be currently using a TENS device for any other reason
- Be currently taking, or have taken in the past 3 months, medications known to cause neuropathy in a significant portion of patients
- Have an acute and symptomatic lower extremity deep vein thrombosis (DVT) (treated DVT with resolution of symptoms is acceptable for enrollment)
- Lower extremity edema that is 2+ or greater (i.e., slight indentation that takes less than 15 seconds to rebound)
Show all 14Show fewer
- Have started a new prescription pain medication or altered dosages of a prescription pain medication within the last 2 weeks
- Have lower extremity wounds or ulcers
- Have a cardiac pace maker or defibrillator
- Have epilepsy
- Have a leg that is too small or too large for the TENS device to fit securely
- Have missing lower limbs or amputations
- Have impaired decision making capacity (i.e., requires a legally authorized representative or health care proxy)
- Be pregnant or planning to get pregnant before expected completion of the study
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Decatur Memorial Hospital
Decatur, Illinois, 62526
Lee Memorial Health System
Fort Myers, Florida, 33905
Gibbs Cancer Center-Gaffney
Gaffney, South Carolina, 29341
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, 49503
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, 54301
St. Vincent Hospital Cancer Center at St. Mary's
Green Bay, Wisconsin, 54303
Prisma Health Cancer Institute - Butternut
Greenville, South Carolina, 29605
Prisma Health Cancer Institute - Faris
Greenville, South Carolina, 29605
Prisma Health Cancer Institute - Eastside
Greenville, South Carolina, 29615
Gibbs Cancer Center-Pelham
Greer, South Carolina, 29651
Christiana Health Care System
Newark, Delaware, 19713
Spartanburg Medical Center
Spartanburg, South Carolina, 29303
MGC Hematology Oncology-Union
Union, South Carolina, 29379
Aspirus
Wausau, Wisconsin, 54401
Metro Health Hospital
Wyoming, Michigan, 49519
About this study
Official title: Wireless Transcutaneous Electrical Nerve Stimulation (TENS) for Chemotherapy-Induced Peripheral Neuropathy: A Phase II Clinical Trial
This phase II trial studies the effects of transcutaneous electrical nerve stimulation (TENS) for the treatment of peripheral neuropathy caused by chemotherapy, often called chemotherapy-induced peripheral neuropathy (CIPN). Peripheral neuropathy refers to the conditions that result when nerves that carry messages to and from the brain and spinal cord from and to the rest of the body are damaged or diseased. The TENS device emits high frequency electrical stimulation through the skin and may provide relief from chronic pain.
Read the detailed description
PRIMARY OBJECTIVE:
- Obtain efficacy estimates of daily TENS on CIPN (European Organization for Research and Treatment of Cancer-CIPN20 [EORTC-CIPN20]) to inform the design of a phase III confirmatory trial.
SECONDARY OBJECTIVES:
- Obtain efficacy estimates of TENS on individual CIPN symptoms (i.e., hot/burning pain, sharp/shooting pain, tingling, numbness, cramping (measured daily via 0 - 10 numeric rating scale [NRS]).
II. Evaluate the feasibility of conducting, within the University of Rochester Cancer Center (URCC) National Cancer Institute Community Oncology Research Program (NCORP) network, a multisite, modified double-blind randomized control trial (RCT) of TENS for CIPN with physiologic assessments of descending inhibition (i.e., conditioned pain modulation [CPM] test) by assessing the proportions of (a) screened patients who enroll, (b) randomized participants who adhere to the treatment and complete the primary assessment, and (c) randomized participants who complete the CPM test.
EXPLORATORY OBJECTIVES:
- Investigate the potential effects of TENS on balance, physical function, descending inhibition, lower limb sensation, and anxiety and depression.
II. Establish data to support the construct validity of the Treatment-Induced Neuropathy Assessment Scale (TNAS) and CIPN symptom inventory daily diary by comparison to the EORTC-CIPN20, which is the most commonly used measure of CIPN.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients wear an active wireless TENS device 5 hours daily for up to 6 weeks in the absence of unacceptable toxicity.
GROUP II: Patients wear a placebo wireless TENS device 5 hours daily for up to 6 weeks in the absence of unacceptable toxicity.
- Being tested
- Placebo Administration, Questionnaire Administration, Transcutaneous Electrical Nerve Stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo AdministrationDevice
Wear placebo TENS device
Questionnaire AdministrationOther
Ancillary studies
Transcutaneous Electrical Nerve StimulationDevice
Also called TENS, transcutaneous electric nerve stimulation
Wear active TENS device
| Study group | Role | What they receive |
|---|---|---|
| Group I (Active TENS) | Experimental | Patients wear an active wireless TENS device 5 hours daily for up to 6 weeks in the absence of unacceptable toxicity. Receives: Other: Questionnaire Administration; Device: Transcutaneous Electrical Nerve Stimulation |
| Group II (Placebo TENS) | Placebo comparator | Patients wear a placebo wireless TENS device 5 hours daily for up to 6 weeks in the absence of unacceptable toxicity. Receives: Device: Placebo Administration; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chemotherapy-induced Peripheral Neuropathy (CIPN) Symptoms
Measured by the mean European Organization for Research and Treatment of Cancer-CIPN20 (EORTC-CIPN20). The effects of transcutaneous electrical nerve stimulation (TENS) on CIPN will be estimated using analysis of covariance (ANCOVA).
A 20 -item patient self -report tool to assess symptoms and function in the sensory, motor and autonomic domains.
Two items, Q49 and Q50, were excluded from the total score calculation. Q49 was relevant only for individuals who could drive, and Q50 was relevant only for men.
0 - 72, a higher score indicates worse neuropathy
Measured: 6 weeks after the start of intervention
Secondary outcomes (5)
Effect of TENS on Hot/Burning Pain
Measured by the CIPN Symptom Inventory; numeric rating scale of 0-10. Higher score is worse. The effects of transcutaneous electrical nerve stimulation (TENS) on hot/burning pain will be estimated using analysis of covariance (ANCOVA) for 2 study populations: (1) Study Completers (N: Active TENS=67, Placebo TENS=62) and (2) participants who reported at least 4 out of 10 at baseline for Hot/Burning Pain. (N: Active TENS=22, Placebo TENS=22).
Measured: 6 weeks after the start of intervention
Effect of TENS on Sharp/Shooting Pain
Measured by the CIPN Symptom Inventory; numeric rating scale of 0-10. Higher score is worse. The effects of transcutaneous electrical nerve stimulation (TENS) on sharp/shooting pain will be estimated using analysis of covariance (ANCOVA) for 2 study populations: (1) Study Completers (N: Active TENS=67, Placebo TENS=62) and (2) participants who reported at least 4 out of 10 at baseline for Sharp/Shooting Pain. (N: Active TENS=24, Placebo TENS=23)
Measured: 6 weeks after the start of intervention
Effect of TENS on Numbness
Measured by the CIPN Symptom Inventory; numeric rating scale of 0-10. Higher score is worse. The effects of transcutaneous electrical nerve stimulation (TENS) on numbness will be estimated using analysis of covariance (ANCOVA) for 2 study populations: (1) Study Completers (N: Active TENS=67, Placebo TENS=62) and (2) participants who reported at least 4 out of 10 at baseline for Numbness. (N: Active TENS=60, Placebo TENS=50)
Measured: 6 weeks after the start of intervention
Effect of TENS on Tingling
Measured by the CIPN Symptom Inventory; numeric rating scale of 0-10. Higher score is worse. The effects of transcutaneous electrical nerve stimulation (TENS) on tingling will be estimated using analysis of covariance (ANCOVA) for 2 study populations: (1) Study Completers (N: Active TENS=67, Placebo TENS=62) and (2) participants who reported at least 4 out of 10 at baseline for Tingling. (N: Active TENS=55, Placebo TENS=50)
Measured: 6 weeks after the start of intervention
Effect of TENS on Cramping
Measured by the CIPN Symptom Inventory; numeric rating scale of 0-10. Higher score is worse. The effects of transcutaneous electrical nerve stimulation (TENS) on cramping will be estimated using analysis of covariance (ANCOVA) for 2 study populations: (1) Study Completers (N: Active TENS=67, Placebo TENS=62) and (2) participants who reported at least 4 out of 10 at baseline for Cramping. (N: Active TENS=18, Placebo TENS=18)
Measured: 6 weeks after the start of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2020
- Study start10 Sep 2020
- Primary completion3 Oct 2022
- Study completion3 Oct 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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chemotherapy-Induced Peripheral NeuropathyStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester NCORP Research Base
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Jennifer Gewandter, University of Rochester NCORP Research Base
- Investigators
- Jennifer Gewandter, Principal investigator, University of Rochester NCORP Research Base
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04367480
- Sponsor's protocol ID
- URCC19085
- Other IDs
- NCI-2019-07566, URCC19085, URCC-19085, URCC-19085, R21CA235389, UG1CA189961
- Status last verified
- Aug 2023
- First submitted
- 21 Apr 2020
- Last updated
- 8 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Rangel M, Besharat S, Sohn MB, Foust M, Francar L, Jorgensen C, Mustian K, Morrow G, Culakova E, Jensen MP, Langford DJ, Gewandter JS. Mean of Daily Versus Single Week Recall-Based Pain Quality Assessments in Neuropathic Pain Trials: Implications for Assay Sensitivity. J Pain. 2024 Nov;25(11):104643. doi: 10.1016/j.jpain.2024.104643. Epub 2024 Jul 25.
PubMed 39067580Gewandter JS, Culakova E, Davis JN, Gada U, Guido JJ, Bearden JD, Burnette B, Shah D, Morrow GR, Mustian K, Sluka KA, Mohile N. Wireless Transcutaneous Electrical Nerve Stimulation (TENS) for Chronic Chemotherapy-Induced Peripheral Neuropathy (CIPN): A Proof-of-Concept Randomized Clinical Trial. J Pain. 2024 May;25(5):104431. doi: 10.1016/j.jpain.2023.11.014. Epub 2023 Nov 21.
PubMed 37993030
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wireless Transcutaneous Electrical Nerve Stimulation (TENS) for Chemotherapy-Induced Peripheral Neuropathy: A Phase II Clinical Trial
- ClinicalTrials.gov ID
- NCT04367480
- Acronym / sponsor ID
- URCC19085
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- University of Rochester NCORP Research BaseUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 10 Sep 2020 (actual)
- Primary completion
- 3 Oct 2022 (actual)
- Study completion
- 3 Oct 2022 (actual)
- First posted
- 29 Apr 2020 (actual)
- Results
- Posted 8 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial studies the effects of transcutaneous electrical nerve stimulation (TENS) for the treatment of peripheral neuropathy caused by chemotherapy, often called chemotherapy-induced peripheral neuropathy (CIPN). Peripheral neuropathy refers to the conditions that result when nerves that carry messages to and from the brain and spinal cord from and to the rest of the body are damaged or diseased. The TENS device emits high frequency electrical stimulation through the skin and may provide relief from chronic pain.
Detailed description
PRIMARY OBJECTIVE:
- Obtain efficacy estimates of daily TENS on CIPN (European Organization for Research and Treatment of Cancer-CIPN20 [EORTC-CIPN20]) to inform the design of a phase III confirmatory trial.
SECONDARY OBJECTIVES:
- Obtain efficacy estimates of TENS on individual CIPN symptoms (i.e., hot/burning pain, sharp/shooting pain, tingling, numbness, cramping (measured daily via 0 - 10 numeric rating scale [NRS]).
II. Evaluate the feasibility of conducting, within the University of Rochester Cancer Center (URCC) National Cancer Institute Community Oncology Research Program (NCORP) network, a multisite, modified double-blind randomized control trial (RCT) of TENS for CIPN with physiologic assessments of descending inhibition (i.e., conditioned pain modulation [CPM] test) by assessing the proportions of (a) screened patients who enroll, (b) randomized participants who adhere to the treatment and complete the primary assessment, and (c) randomized participants who complete the CPM test.
EXPLORATORY OBJECTIVES:
- Investigate the potential effects of TENS on balance, physical function, descending inhibition, lower limb sensation, and anxiety and depression.
II. Establish data to support the construct validity of the Treatment-Induced Neuropathy Assessment Scale (TNAS) and CIPN symptom inventory daily diary by comparison to the EORTC-CIPN20, which is the most commonly used measure of CIPN.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients wear an active wireless TENS device 5 hours daily for up to 6 weeks in the absence of unacceptable toxicity.
GROUP II: Patients wear a placebo wireless TENS device 5 hours daily for up to 6 weeks in the absence of unacceptable toxicity.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (Active TENS) | Experimental | Other: Questionnaire Administration, Device: Transcutaneous Electrical Nerve StimulationPatients wear an active wireless TENS device 5 hours daily for up to 6 weeks in the absence of unacceptable toxicity. |
| Group II (Placebo TENS) | Placebo comparator | Device: Placebo Administration, Other: Questionnaire AdministrationPatients wear a placebo wireless TENS device 5 hours daily for up to 6 weeks in the absence of unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Have completed treatment with a platinum agent, taxane, vinca alkaloid, or bortezomib at least 3 months prior to registration
- Have a clinical diagnosis of CIPN from their physician or physician designee based on the following criteria: bilateral (i.e., present on both sides of the body), abnormal sensory symptoms in their feet or legs (e.g., hot/burning pain, sharp/shooting pain, numbness, tingling, cramping)
- Report at least 1 non-painful symptom associated with CIPN in their lower limbs (e.g., tingling, burning that isn't reported as painful, numbness)
- Report at least 2 of the following symptoms in their lower limbs (at their worst) as at least 4 out of 10 on a 0 - 10 NRS: hot/burning pain, sharp/shooting pain, numbness, tingling, cramping at visit 1 (i.e., week -1). Use the CIPN Symptom Inventory - week recall form (questions 1-5 ONLY) to assess these symptoms at screening
- Be willing and able not to start any new analgesic medications or change the dosages of any current analgesic medications (except acetaminophen [Tylenol] or non-steroidal anti-inflammatory drugs [NSAIDs] [i.e., ibuprofen (Advil, Motrin), naproxen (Aleve)]) for the duration of the study
Key exclusion criteria (14 listed)
- Have pre-existing neuropathy of any cause documented in their medical record prior to the start of chemotherapy or respond "yes" to the question "Did you have frequent numbness, tingling, sharp/shooting pain, hot/burning pain, or cramping in your feet before you started your chemotherapy?"
- Have unilateral CIPN symptoms (i.e., symptoms occur on predominantly only one side of the body)
- Be currently using a TENS device for any other reason
- Be currently taking, or have taken in the past 3 months, medications known to cause neuropathy in a significant portion of patients
- Have an acute and symptomatic lower extremity deep vein thrombosis (DVT) (treated DVT with resolution of symptoms is acceptable for enrollment)
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 |
|---|---|---|
| Placebo AdministrationWear placebo TENS device | Device | Group II (Placebo TENS) |
| Questionnaire AdministrationAncillary studies | Other | Group I (Active TENS), Group II (Placebo TENS) |
| Transcutaneous Electrical Nerve StimulationAlso: TENS, transcutaneous electric nerve stimulationWear active TENS device | Device | Group I (Active TENS) |
Primary outcome
Chemotherapy-induced Peripheral Neuropathy (CIPN) Symptoms
Time frame: 6 weeks after the start of intervention
Measured by the mean European Organization for Research and Treatment of Cancer-CIPN20 (EORTC-CIPN20). The effects of transcutaneous electrical nerve stimulation (TENS) on CIPN will be estimated using analysis of covariance (ANCOVA). A 20 -item patient self -report tool to assess symptoms and function in the sensory, motor and autonomic domains. Two items, Q49 and Q50, were excluded from the total score calculation. Q49 was relevant only for individuals who could drive, and Q50 was relevant only for men. 0 - 72, a higher score indicates worse neuropathy
5 secondary outcomes
Effect of TENS on Hot/Burning Pain
Time frame: 6 weeks after the start of intervention
Effect of TENS on Sharp/Shooting Pain
Time frame: 6 weeks after the start of intervention
Effect of TENS on Numbness
Time frame: 6 weeks after the start of intervention
Effect of TENS on Tingling
Time frame: 6 weeks after the start of intervention
Effect of TENS on Cramping
Time frame: 6 weeks after the start of intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39067580Rangel M, Besharat S, Sohn MB, Foust M, Francar L, Jorgensen C, Mustian K, Morrow G, Culakova E, Jensen MP, Langford DJ, Gewandter JS. Mean of Daily Versus Single Week Recall-Based Pain Quality Assessments in Neuropathic Pain Trials: Implications for Assay Sensitivity. J Pain. 2024 Nov;25(11):104643. doi: 10.1016/j.jpain.2024.104643. Epub 2024 Jul 25.
- Derived from this study: PubMed 37993030Gewandter JS, Culakova E, Davis JN, Gada U, Guido JJ, Bearden JD, Burnette B, Shah D, Morrow GR, Mustian K, Sluka KA, Mohile N. Wireless Transcutaneous Electrical Nerve Stimulation (TENS) for Chronic Chemotherapy-Induced Peripheral Neuropathy (CIPN): A Proof-of-Concept Randomized Clinical Trial. J Pain. 2024 May;25(5):104431. doi: 10.1016/j.jpain.2023.11.014. Epub 2023 Nov 21.
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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.
Jennifer Gewandter principal investigator
University of Rochester NCORP Research Base
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaire Administration and Transcutaneous Electrical Nerve Stimulation in people with Chemotherapy-Induced Peripheral Neuropathy, run by University of Rochester NCORP Research Base at 15 sites 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 7 inclusion and 14 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 8 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites 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. Some participants in this study may receive a placebo. 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 8 Sep 2023). 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?
Chemotherapy-induced Peripheral Neuropathy (CIPN) Symptoms (time frame: 6 weeks after the start of intervention). 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 NCT04367480, which also lists 2 linked publications.
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 8 Sep 2023.