Chemotherapy-induced NeuropathyCINNCT01557608
Characterization and Treatment of Chemotherapy Neuropathy
A study testing Photon stimulation in people with Chemotherapy-induced Neuropathy, run by University of California, San Francisco at 1 site in United States.
Trial summary
Numbness, tingling, and pain in the hands and feet following the administration of chemotherapy (also called chemotherapy-induced neuropathy (CIN)) is a common problem in oncology patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy-induced Neuropathy
- What is being tested?
- Photon stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 754 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to 8 Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- is an adult >18 years of age;
- has received a platinum compound and/or a taxane;
- has completed a course of CTX;
- has changes in sensation and/or pain in their feet of >3 months duration following the completion of CTX;
- has a rating of >3 on a 0 to 10 numeric rating scale (NRS) on any one of the following sensations from the Pain Qualities Assessment Scale (i.e., numb, tender, shooting, sensitive, electrical, tingling radiating, throbbing, cramping, itchy, unpleasant),91
- if they have pain associated with the CIN, has an average pain intensity score in their feet of >3 on a 0 to 10 NRS;
Show all 9Show fewer
- has a Karnofsky Performance Status (KPS) score of >50;
- is able to read, write, and understand English; and
- signs a written informed consent.
Who cannot join
- If they have CIN in their hands, because we have no experience treating CIN in patients' hands with photon stimulation and the photon stimulator is designed to provide treatment only to the feet.
- Women will be excluded if they intend to become or are pregnant or lactating. Men and women will be required to take active measures to prevent pregnancy while on the study.
- If unwilling to provide the scheduled blood specimens they will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California
San Francisco, California, 94143
About this study
Official title: Characterization of and Treatment for Chemotherapy-Induced Neuropathy
Numbness, tingling, and pain in the hands and feet following the administration of chemotherapy (also called chemotherapy-induced neuropathy (CIN)) is a common problem in oncology patients. However, more information is needed on why patients develop neuropathy and how it impacts their mood, ability to function, and their quality of life. In addition, effective treatments for this problem are not available at the present time. This study will be conducted in two parts. In Part 1, patients who have finished chemotherapy and did or did not develop CIN will be evaluated to determine why some patients do and other patients do not develop CIN. In addition, the impact of CIN on patients' mood, function, and quality of life will be evaluated by comparing patients' reports on these important outcome measures. In addition, genetic markers that contribute to or protect against the development of CIN will be evaluated. Part 2 of this study will test the effects of a new treatment called photon stimulation (also called infrared light therapy) compared to placebo treatment to improve sensations in the feet of oncology patients with CIN. Patients who receive the photon stimulation will have greater improvement in sensation in their feet compared with those who do not receive photon stimulation.
Read the detailed description
This protocol is designed in two parts. Part 1 will use an "extreme phenotype" approach to evaluate the phenotypic and genotypic characteristics of chemotherapy induced neuropathy(CIN)in a sample of oncology patients who have completed their chemotherapy and did(n=400)and did not (n=200) develop CIN. Patients with and without CIN will be matched, in a 2 to 1 ratio, on their cancer diagnosis and CTX agents administered (i.e., only a platinum compound, only a taxane, or both). Patients will be recruited in cohorts of 30 to 40 to insure that the matching criteria are met and the 2:1 ratio is achieved.
In a single study visit, to take place at the outpatient CTSI CRC (CCRC) at Mt. Zion,participants will be enrolled, complete a battery of sensorimotor tests and questionnaires, and provide a single blood specimen for genomic analysis.
Part 2 will be a pilot study of a randomized, double-blind, placebo-controlled clinical trial (RDBPCT) of photon stimulation in a sample of patients (n=142) with CIN who participated in Part 1. Participants will be randomized to receive the active treatment or the placebo in a series of 8 treatments, lasting 7 minutes each, across a 14-day period. Participants will be assessed at baseline and after the 2nd, 4th, 6th, and 8th treatments with sensory, motor, balance, pain intensity and pain quality measures, mood, and quality of life measures. Blood specimens will be drawn on treatment days 1, 4, 5, and 8 for gene expression.
10.1 * Study design: 10.2 Check
- Conditions
- Chemotherapy-induced Neuropathy
- Being tested
- Photon stimulation, Placebo treatment
- Keywords
- cancer, chemotherapy, photon stimulation, neuropathy, pain
- Medical subject headings
- Neoplasms, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photon stimulationProcedure or surgery
The LED diode wavelength chosen for this study is 870 nanometers. When activated, the photon stimulator is preset to deliver 1800 Joules in a 7 minute treatment period. Patients will receive a total of 8 treatments, to both feet simultaneously, within a 14 day period depending on their schedule.
Placebo treatmentProcedure or surgery
For patients who receive the placebo treatment, the electronic control unit will be deactivated (i.e., no energy is delivered) even though the indicator lights will be illuminated when the power switch is turned to the "ON" position. Using this procedure, the research nurse who administers the treatments and collects the outcome data will be blinded to the patients' group assignment.
| Study group | Role | What they receive |
|---|---|---|
| Photon stimulation | Experimental | Not described Receives: Procedure: Photon stimulation |
| Placebo treatment | Placebo comparator | Not described Receives: Procedure: Placebo treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes over time in light touch sensation
Light touch sensation will be measured using Semmes Weinstein monofilaments.
Measured: Treatment days 1, 2, 4, 6, and 8
Secondary outcomes (4)
Safety measures
Skin will be assessed for redness and swelling.
Measured: Before and after each treatment on days 1 through 8
Changes over time in pain qualities
Pain qualities will be assessed using the Pain Qualities Assessment Scale
Measured: Treatment days 2, 4, 6, 8
Changes over time in average pain intensity
Average pain will be assessed using a 0 to 10 numeric rating scale.
Measured: Treatment days 1 through 8
Changes over time in worst pain intensity
Worst pain will be assessed using a 0 to 10 numeric rating scale.
Measured: Treatment days 1 through 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2012 (estimated)
- Study startApr 2012
- Primary completion8 Dec 2015
- Study completion8 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-induced NeuropathyStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 754 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christine A. Miaskowski, RN, PHD, Principal investigator, University of California, San FranciscoBradley Aouizerat, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01557608
- Sponsor's protocol ID
- R01CA151692
- Acronym
- CIN
- Status last verified
- Jan 2020
- First submitted
- 28 Feb 2012
- Last updated
- 14 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of and Treatment for Chemotherapy-Induced Neuropathy
- ClinicalTrials.gov ID
- NCT01557608
- Acronym / sponsor ID
- CIN / R01CA151692
- Conditions
- Chemotherapy-induced Neuropathy
- Keywords
- cancer, chemotherapy, photon stimulation, neuropathy, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 754 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- 8 Dec 2015 (actual)
- Study completion
- 8 Dec 2015 (actual)
- First posted
- 19 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Numbness, tingling, and pain in the hands and feet following the administration of chemotherapy (also called chemotherapy-induced neuropathy (CIN)) is a common problem in oncology patients. However, more information is needed on why patients develop neuropathy and how it impacts their mood, ability to function, and their quality of life. In addition, effective treatments for this problem are not available at the present time. This study will be conducted in two parts. In Part 1, patients who have finished chemotherapy and did or did not develop CIN will be evaluated to determine why some patients do and other patients do not develop CIN. In addition, the impact of CIN on patients' mood, function, and quality of life will be evaluated by comparing patients' reports on these important outcome measures. In addition, genetic markers that contribute to or protect against the development of CIN will be evaluated. Part 2 of this study will test the effects of a new treatment called photon stimulation (also called infrared light therapy) compared to placebo treatment to improve sensations in the feet of oncology patients with CIN. Patients who receive the photon stimulation will have greater improvement in sensation in their feet compared with those who do not receive photon stimulation.
Detailed description
This protocol is designed in two parts. Part 1 will use an "extreme phenotype" approach to evaluate the phenotypic and genotypic characteristics of chemotherapy induced neuropathy(CIN)in a sample of oncology patients who have completed their chemotherapy and did(n=400)and did not (n=200) develop CIN. Patients with and without CIN will be matched, in a 2 to 1 ratio, on their cancer diagnosis and CTX agents administered (i.e., only a platinum compound, only a taxane, or both). Patients will be recruited in cohorts of 30 to 40 to insure that the matching criteria are met and the 2:1 ratio is achieved.
In a single study visit, to take place at the outpatient CTSI CRC (CCRC) at Mt. Zion,participants will be enrolled, complete a battery of sensorimotor tests and questionnaires, and provide a single blood specimen for genomic analysis.
Part 2 will be a pilot study of a randomized, double-blind, placebo-controlled clinical trial (RDBPCT) of photon stimulation in a sample of patients (n=142) with CIN who participated in Part 1. Participants will be randomized to receive the active treatment or the placebo in a series of 8 treatments, lasting 7 minutes each, across a 14-day period. Participants will be assessed at baseline and after the 2nd, 4th, 6th, and 8th treatments with sensory, motor, balance, pain intensity and pain quality measures, mood, and quality of life measures. Blood specimens will be drawn on treatment days 1, 4, 5, and 8 for gene expression.
10.1 * Study design: 10.2 Check
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 |
|---|---|---|
| Photon stimulation | Experimental | Procedure: Photon stimulation |
| Placebo treatment | Placebo comparator | Procedure: Placebo treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- is an adult >18 years of age;
- has received a platinum compound and/or a taxane;
- has completed a course of CTX;
- has changes in sensation and/or pain in their feet of >3 months duration following the completion of CTX;
- has a rating of >3 on a 0 to 10 numeric rating scale (NRS) on any one of the following sensations from the Pain Qualities Assessment Scale (i.e., numb, tender, shooting, sensitive, electrical, tingling radiating, throbbing, cramping, itchy, unpleasant),91
Key exclusion criteria (3 listed)
- If they have CIN in their hands, because we have no experience treating CIN in patients' hands with photon stimulation and the photon stimulator is designed to provide treatment only to the feet.
- Women will be excluded if they intend to become or are pregnant or lactating. Men and women will be required to take active measures to prevent pregnancy while on the study.
- If unwilling to provide the scheduled blood specimens they will be excluded.
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 |
|---|---|---|
| Photon stimulationThe LED diode wavelength chosen for this study is 870 nanometers. When activated, the photon stimulator is preset to deliver 1800 Joules in a 7 minute treatment period. Patients will receive a total of 8 treatments, to both feet simultaneously, within a 14 day period depending on their schedule. | Procedure or surgery | Photon stimulation |
| Placebo treatmentFor patients who receive the placebo treatment, the electronic control unit will be deactivated (i.e., no energy is delivered) even though the indicator lights will be illuminated when the power switch is turned to the "ON" position. Using this procedure, the research nurse who administers the treatments and collects the outcome data will be blinded to the patients' group assignment. | Procedure or surgery | Placebo treatment |
Primary outcome
Changes over time in light touch sensation
Time frame: Treatment days 1, 2, 4, 6, and 8
Light touch sensation will be measured using Semmes Weinstein monofilaments.
4 secondary outcomes
Safety measures
Time frame: Before and after each treatment on days 1 through 8
Changes over time in pain qualities
Time frame: Treatment days 2, 4, 6, 8
Changes over time in average pain intensity
Time frame: Treatment days 1 through 8
Changes over time in worst pain intensity
Time frame: Treatment days 1 through 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2020.
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Continuous Controlled Cooling for Prevention of Chemotherapy-Induced Peripheral Neuropathy
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NeuroGuard: Psilocybin Trial for Preventing Chemo-induced Neuropathy
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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.
Christine A. Miaskowski, RN, PHD principal investigator
University of California, San Francisco
Bradley Aouizerat, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photon stimulation in people with Chemotherapy-induced Neuropathy, run by University of California, San Francisco 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 9 inclusion and 3 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 14 Jan 2020. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes over time in light touch sensation (time frame: Treatment days 1, 2, 4, 6, and 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jan 2020.