Chemotherapy-induced Peripheral NeuropathyPhase 4NCT07834281
High-concentration Capsaicin Patch for the Prevention of Paclitaxel-induced Peripheral Neuropathy
A Phase 4 study testing High Concentration Capsaicin Patch (HCCP) in people with Chemotherapy-induced Peripheral Neuropathy and CIPN - Chemotherapy-Induced Peripheral Neuropathy, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
This research study is for participants who are receiving paclitaxel infusion as part of their cancer treatment. The purpose of this study is to test the effectiveness of the Food and Drug Administration (FDA) approved high-concentration (8%) capsaicin patch (HCCP) in prevention of taxane-induced peripheral neuropathy… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chemotherapy-induced Peripheral Neuropathy, CIPN - Chemotherapy-Induced Peripheral Neuropathy
- What is being tested?
- High Concentration Capsaicin Patch (HCCP)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2026to Jun 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult participants (ages 18-65 years old)
- Eligible participants must have intact skin in the areas to be treated (hands and feet)
- Participants must have the ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Participants with pre-existing peripheral neuropathy, concurrent use of other neurotoxic medications, palliative-intent chemotherapy, pregnancy, inability to provide informed consent or participate in follow-up visits, or any contraindications listed in the HCCP Summary of Product Characteristics (SmPC)8 will be excluded.
- Pregnant or breastfeeding women are excluded from this study because Paclitaxel is a chemotherapy agent with the potential for teratogenic or abortifacient effects.
- HIV-positive participants will not be excluded unless the participant has an established peripheral neuropathy related to HIV or its treatment. HIV testing is not required for this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
Cleveland, Ohio, 44195
Jijun Xu, MD, PhD, 216-444-4080, Xuj3@ccf.org
Jijun Xu, MD, PhD
About this study
Official title: High-concentration Capsaicin Patch for the Prevention of Paclitaxel-induced Peripheral Neuropathy- a Prospective, Double-blind, Randomized, Placebo-controlled Trial
This research study is for participants who are receiving paclitaxel infusion as part of their cancer treatment. The purpose of this study is to test the effectiveness of the Food and Drug Administration (FDA) approved high-concentration (8%) capsaicin patch (HCCP) in prevention of taxane-induced peripheral neuropathy (nerve pain in hands and/or feet). Participants will be randomized, like flipping a coin, into one of four groups. Group one will receive the HCCP on one hand and one foot 60 minutes prior to each infusion. Group two will receive the HCCP on one hand and one foot 30 minutes prior to each infusion. Group three will receive a placebo patch on one hand and one foot containing a very low concentration of capsaicin (0.025%) for 60 minutes prior to infusion. Group four will receive a placebo patch on one hand and one foot for 30 minutes prior to infusion. Participants will have an equal chance of being placed in each of the four groups.
Read the detailed description
Chemotherapy-induced peripheral neuropathy (CIPN) is a common, serious side effect of drugs used to treat cancer, such as taxanes. CIPN affects up to 80% of people receiving chemotherapy cancer treatment, and the incidence of CIPN is expected to increase as cancer survival increases. CIPN can cause sensory loss, neuropathic (nerve-related) pain, gait instability (problems with balance), and fine motor impairment. These symptoms can often continue for years after treatment is completed. These symptoms may also cause doctors to lower or stop chemotherapy, which may affect the outcomes of cancer treatment. CIPN is a leading cause of poor quality of life for millions of cancer survivors.
Despite how common and serious CIPN is, there are no FDA-approved preventive therapies for CIPN. The high-concentration capsaicin patch (HCCP, 8%) is an FDA-approved topical therapy for peripheral neuropathic pain that acts by prolonged activation and reversible "defunctionalization" of nerve cells called Transient Receptor Potential Vanilloid 1 (TRPV1)-expressing sensory neurons. TRPV1 plays an important role in how pain is felt by acting as a receptor on sensory neurons. This means that it detects and relays painful stimuli to the central nervous system. Damaging TRPV1 by using the topical HCCP patch leads to temporary relief without permanent nerve injury or systemic side effects. HCCP has demonstrated clinical efficacy in treating established CIPN; however, its use as a preventive intervention has not been reported. Preclinical and translational data indicate that early modulation of TRPV1-calcium signaling may prevent maladaptive neuronal hyperexcitability and epigenetic changes that underlie chronic neuropathy. Thus, repurposing HCCP to preemptively modulate this pathway represents a novel, mechanism-based opportunity to prevent CIPN before irreversible neurodegeneration occurs.
This project directly addresses a high-impact unmet need by testing whether pretreatment with HCCP reduces the incidence and severity of CIPN. By integrating a randomized, placebo-controlled clinical trial with multimodal neurophysiological, participant-reported, and molecular assessments, this work will generate rigorous clinical and mechanistic evidence supporting a scalable, non-invasive, and rapidly translatable prevention strategy. If successful, these findings will shift the CIPN management paradigm from reactive symptom control to proactive prevention, improving treatment adherence, functional outcomes, and survivorship quality.
- Conditions
- Chemotherapy-induced Peripheral Neuropathy, CIPN - Chemotherapy-Induced Peripheral Neuropathy
- Being tested
- High Concentration Capsaicin Patch (HCCP), Placebo patch
- Keywords
- high-concentration capsaicin patch, HCCP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Concentration Capsaicin Patch (HCCP)Other
Participants will receive 8% HCCP patch. It will be administered on the hand or foot for either 30 or 60 minutes, depending on which arm the participant is in. It will be administered at baseline (Week 0), just prior to starting standard of care chemotherapy. It will be administered again on Week 11, as long as the participant is expected to receive standard of care chemotherapy on Week 12.
Placebo patchOther
Participants will receive the placebo patch containing 0.025% capsaicin. It will be administered on the hand or foot for either 30 or 60 minutes, depending on which arm the participant is in. It will be administered at baseline (Week 0), just prior to starting standard of care chemotherapy. It will be administered again on Week 11, as long as the participant is expected to receive standard of care chemotherapy on Week 12.
| Study group | Role | What they receive |
|---|---|---|
| HCCP 30-minute application | Experimental | The 8% High Concentration Capsaicin Patch (HCCP) patch will be administered in an outpatient setting one week prior to the initiation of standard of care chemotherapy. The patch will be administered either on the hand or foot. It will be applied for 30 minutes. If the participant is expected to receive standard of care chemotherapy at Week 12, then they will receive a second HCCP patch on Week 11. Receives: Other: High Concentration Capsaicin Patch (HCCP) |
| HCCP 60-minute application | Experimental | The 8% High Concentration Capsaicin Patch (HCCP) patch will be administered in an outpatient setting one week prior to the initiation of standard of care chemotherapy. The patch will be administered either on the hand or foot. It will be applied for 60 minutes. If the participant is expected to receive standard of care chemotherapy at Week 12, then they will receive a second HCCP patch on Week 11. Receives: Other: High Concentration Capsaicin Patch (HCCP) |
| Placebo 30-minute application | Placebo comparator | This arm will receive a matched placebo patch containing 0.025% capsaicin. The patch will be administered in an outpatient setting one week prior to the initiation of standard of care chemotherapy. The patch will be administered either on the hand or foot. It will be applied for 30 minutes. If the participant is expected to receive standard of care chemotherapy at Week 12, then they will receive a second HCCP patch on Week 11. Receives: Other: Placebo patch |
| Placebo 60-minute application | Placebo comparator | This arm will receive a matched placebo patch containing 0.025% capsaicin. The patch will be administered in an outpatient setting one week prior to the initiation of standard of care chemotherapy. The patch will be administered either on the hand or foot. It will be applied for 60 minutes. If the participant is expected to receive standard of care chemotherapy at Week 12, then they will receive a second HCCP patch on Week 11. Receives: Other: Placebo patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in taxane-induced peripheral neuropathy due to HCCP patch
Change in taxane-induced peripheral neuropathy is measured by the incidence of grade ≥2 neuropathy (Common Terminology Criteria for Adverse Events, CTCAE v5.0).
Measured: Baseline (Day 0), Week 1, Week 4, Week 12, Week 24, Week 52
Secondary outcomes (11)
Change in FACT-GOG-Ntx scores
The Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) is a 13-item questionnaire that asks participants to rank symptoms of daily function on a 5-point Likert scale from Not at all (0) to Very much (4). Higher scores indicate greater quality of life.
Measured: Baseline (Day 0), Week 1, Week 4, Week 12, Week 24, Week 52
Change in PROMIS Pain Interference scores
The Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference questionnaire is a 8-item questionnaire that assesses the daily impacts of pain. Each item is answered on a 5-point Likert scale from Not at all (1) to Very much (5). Higher scores indicate greater pain interference.
Measured: Baseline (Day 0), Week 1, Week 4, Week 12, Week 24, Week 52
Change in PROMIS Physical Function scores
The Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function questionnaire is a 8-item questionnaire that assesses daily physical functioning. Four questions are answered on a 5-point Likert scale from Without any difficulty (5) to Unable to do (1), and the other 4 questions answered on a 5-point Likert scale from Not at all (5) to Cannot do (1). Higher scores indicate greater physical functioning.
Measured: Baseline (Day 0), Week 1, Week 4, Week 12, Week 24, Week 52
Change in PROMIS Sleep Disturbance scores
The Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance questionnaire is a 8-item questionnaire that assesses sleep disturbance. One question asks participants to ran their sleep quality on a 5-point scale from "Very poor" to "Very good." Seven questions are answered on a 5-point Likert scale from Not at all (5) to Very much (1). Higher scores indicate worse sleep disturbance.
Measured: Baseline (Day 0), Week 1, Week 4, Week 12, Week 24, Week 52
Change in EQ-5D-5L scores
The EuroQol 5-Dimension, 5-Level (EQ-5D-5L) questionnaire has 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels that the participant can choose from: no problems, slight problems, moderate problems, severe problems and extreme problems. These numbers are combined for a 5-digit number that describes the participant's health status.
Measured: Baseline (Day 0), Week 1, Week 4, Week 12, Week 24, Week 52
Change in Patient Global Impression of Change (PGIC) scores
Patient Global Impression of Change (PGIC) questionnaire contains one question that asks the participant to rank their overall health status on a 7-point Likert scale from (1) Very much improved to (7) Very much worse. Higher scores indicate worse health status.
Measured: Baseline (Day 0), Week 1, Week 4, Week 12, Week 24, Week 52
Change in EORTC QLQ-CIPN20 scores
The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Chemotherapy-Induced Peripheral Neuropathy 20-Item Scale (EORTC QLQ-CIPN20) questionnaire is a 20-item questionnaire that assess symptoms of chemotherapy-induced peripheral neuropathy (CIPN). Participants answer questions on a 4-point Likert scale from Not at all (1) to Very much (4). Higher scores indicate greater symptoms of CIPN.
Measured: Baseline (Day 0), Week 1, Week 4, Week 12, Week 24, Week 52
Change in Numeric Rating Scale for pain (NRS) scores
The Numeric Rating Scale (NRS) for pain is a one-item question that asks participants to rank their pain on a scale of 0 to 10 from None (0) to Severe (10). Higher rankings indicate more severe pain.
Measured: Baseline (Day 0), Week 1, Week 4, Week 12, Week 24, Week 52
Time-to-onset of paclitaxel-induced peripheral neuropathy (PIPN)
Time-to-onset of PIPN will be measured as the days from start of treatment (Week 1) to the first reported day of PIPN. This question will be asked at Baseline (Day 0), Week 1, Week 4, Week 12, Week 24, Week 52.
Measured: Baseline (Day 0), Week 1, Week 4, Week 12, Week 24, Week 52
Cumulative paclitaxel dose
Cumulative paclitaxel dose will be measured as the amount of paclitaxel a participant receives in total (from Week 0 and up to Week 52). This question will be asked at Baseline (Day 0), Week 1, Week 4, Week 12, Week 24, Week 52.
Measured: Baseline (Day 0), Week 1, Week 4, Week 12, Week 24, Week 52
Dose reductions or delays due to neuropathy
The number of instances of dose reductions or delays due to neuropathy will be measured as the incidence in total (from Week 0 and up to Week 52). This question will be asked at Baseline (Day 0), Week 1, Week 4, Week 12, Week 24, Week 52.
Measured: Baseline (Day 0), Week 1, Week 4, Week 12, Week 24, Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-induced Peripheral NeuropathyStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jijun Xu, MD, PhD, Principal investigator, Case Comprehensive Cancer Center, Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07834281
- Sponsor's protocol ID
- CASE10Z26
- Status last verified
- Sep 2026
- First submitted
- 17 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-concentration Capsaicin Patch for the Prevention of Paclitaxel-induced Peripheral Neuropathy- a Prospective, Double-blind, Randomized, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT07834281
- Acronym / sponsor ID
- CASE10Z26
- Conditions
- Chemotherapy-induced Peripheral Neuropathy, CIPN - Chemotherapy-Induced Peripheral Neuropathy
- Keywords
- high-concentration capsaicin patch, HCCP
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 22 Sep 2026 (actual)
- 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.
This research study is for participants who are receiving paclitaxel infusion as part of their cancer treatment. The purpose of this study is to test the effectiveness of the Food and Drug Administration (FDA) approved high-concentration (8%) capsaicin patch (HCCP) in prevention of taxane-induced peripheral neuropathy (nerve pain in hands and/or feet). Participants will be randomized, like flipping a coin, into one of four groups. Group one will receive the HCCP on one hand and one foot 60 minutes prior to each infusion. Group two will receive the HCCP on one hand and one foot 30 minutes prior to each infusion. Group three will receive a placebo patch on one hand and one foot containing a very low concentration of capsaicin (0.025%) for 60 minutes prior to infusion. Group four will receive a placebo patch on one hand and one foot for 30 minutes prior to infusion. Participants will have an equal chance of being placed in each of the four groups.
Detailed description
Chemotherapy-induced peripheral neuropathy (CIPN) is a common, serious side effect of drugs used to treat cancer, such as taxanes. CIPN affects up to 80% of people receiving chemotherapy cancer treatment, and the incidence of CIPN is expected to increase as cancer survival increases. CIPN can cause sensory loss, neuropathic (nerve-related) pain, gait instability (problems with balance), and fine motor impairment. These symptoms can often continue for years after treatment is completed. These symptoms may also cause doctors to lower or stop chemotherapy, which may affect the outcomes of cancer treatment. CIPN is a leading cause of poor quality of life for millions of cancer survivors.
Despite how common and serious CIPN is, there are no FDA-approved preventive therapies for CIPN. The high-concentration capsaicin patch (HCCP, 8%) is an FDA-approved topical therapy for peripheral neuropathic pain that acts by prolonged activation and reversible "defunctionalization" of nerve cells called Transient Receptor Potential Vanilloid 1 (TRPV1)-expressing sensory neurons. TRPV1 plays an important role in how pain is felt by acting as a receptor on sensory neurons. This means that it detects and relays painful stimuli to the central nervous system. Damaging TRPV1 by using the topical HCCP patch leads to temporary relief without permanent nerve injury or systemic side effects. HCCP has demonstrated clinical efficacy in treating established CIPN; however, its use as a preventive intervention has not been reported. Preclinical and translational data indicate that early modulation of TRPV1-calcium signaling may prevent maladaptive neuronal hyperexcitability and epigenetic changes that underlie chronic neuropathy. Thus, repurposing HCCP to preemptively modulate this pathway represents a novel, mechanism-based opportunity to prevent CIPN before irreversible neurodegeneration occurs.
This project directly addresses a high-impact unmet need by testing whether pretreatment with HCCP reduces the incidence and severity of CIPN. By integrating a randomized, placebo-controlled clinical trial with multimodal neurophysiological, participant-reported, and molecular assessments, this work will generate rigorous clinical and mechanistic evidence supporting a scalable, non-invasive, and rapidly translatable prevention strategy. If successful, these findings will shift the CIPN management paradigm from reactive symptom control to proactive prevention, improving treatment adherence, functional outcomes, and survivorship quality.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HCCP 30-minute application | Experimental | Other: High Concentration Capsaicin Patch (HCCP)The 8% High Concentration Capsaicin Patch (HCCP) patch will be administered in an outpatient setting one week prior to the initiation of standard of care chemotherapy. The patch will be administered either on the hand or foot. It will be applied for 30 minutes. If the participant is expected to receive standard of care chemotherapy at Week 12, then they will receive a second HCCP patch on Week 11. |
| HCCP 60-minute application | Experimental | Other: High Concentration Capsaicin Patch (HCCP)The 8% High Concentration Capsaicin Patch (HCCP) patch will be administered in an outpatient setting one week prior to the initiation of standard of care chemotherapy. The patch will be administered either on the hand or foot. It will be applied for 60 minutes. If the participant is expected to receive standard of care chemotherapy at Week 12, then they will receive a second HCCP patch on Week 11. |
| Placebo 30-minute application | Placebo comparator | Other: Placebo patchThis arm will receive a matched placebo patch containing 0.025% capsaicin. The patch will be administered in an outpatient setting one week prior to the initiation of standard of care chemotherapy. The patch will be administered either on the hand or foot. It will be applied for 30 minutes. If the participant is expected to receive standard of care chemotherapy at Week 12, then they will receive a second HCCP patch on Week 11. |
| Placebo 60-minute application | Placebo comparator | Other: Placebo patchThis arm will receive a matched placebo patch containing 0.025% capsaicin. The patch will be administered in an outpatient setting one week prior to the initiation of standard of care chemotherapy. The patch will be administered either on the hand or foot. It will be applied for 60 minutes. If the participant is expected to receive standard of care chemotherapy at Week 12, then they will receive a second HCCP patch on Week 11. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult participants (ages 18-65 years old)
- Eligible participants must have intact skin in the areas to be treated (hands and feet)
- Participants must have the ability to understand and the willingness to sign a written informed consent document.
Key exclusion criteria (3 listed)
- Participants with pre-existing peripheral neuropathy, concurrent use of other neurotoxic medications, palliative-intent chemotherapy, pregnancy, inability to provide informed consent or participate in follow-up visits, or any contraindications listed in the HCCP Summary of Product Characteristics (SmPC)8 will be excluded.
- Pregnant or breastfeeding women are excluded from this study because Paclitaxel is a chemotherapy agent with the potential for teratogenic or abortifacient effects.
- HIV-positive participants will not be excluded unless the participant has an established peripheral neuropathy related to HIV or its treatment. HIV testing is not required for this study.
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 |
|---|---|---|
| High Concentration Capsaicin Patch (HCCP)Participants will receive 8% HCCP patch. It will be administered on the hand or foot for either 30 or 60 minutes, depending on which arm the participant is in. It will be administered at baseline (Week 0), just prior to starting standard of care chemotherapy. It will be administered again on Week 11, as long as the participant is expected to receive standard of care chemotherapy on Week 12. | Other | HCCP 30-minute application, HCCP 60-minute application |
| Placebo patchParticipants will receive the placebo patch containing 0.025% capsaicin. It will be administered on the hand or foot for either 30 or 60 minutes, depending on which arm the participant is in. It will be administered at baseline (Week 0), just prior to starting standard of care chemotherapy. It will be administered again on Week 11, as long as the participant is expected to receive standard of care chemotherapy on Week 12. | Other | Placebo 30-minute application, Placebo 60-minute application |
Primary outcome
Change in taxane-induced peripheral neuropathy due to HCCP patch
Time frame: Baseline (Day 0), Week 1, Week 4, Week 12, Week 24, Week 52
Change in taxane-induced peripheral neuropathy is measured by the incidence of grade ≥2 neuropathy (Common Terminology Criteria for Adverse Events, CTCAE v5.0).
11 secondary outcomes
Change in FACT-GOG-Ntx scores
Time frame: Baseline (Day 0), Week 1, Week 4, Week 12, Week 24, Week 52
Change in PROMIS Pain Interference scores
Time frame: Baseline (Day 0), Week 1, Week 4, Week 12, Week 24, Week 52
Change in PROMIS Physical Function scores
Time frame: Baseline (Day 0), Week 1, Week 4, Week 12, Week 24, Week 52
Change in PROMIS Sleep Disturbance scores
Time frame: Baseline (Day 0), Week 1, Week 4, Week 12, Week 24, Week 52
Change in EQ-5D-5L scores
Time frame: Baseline (Day 0), Week 1, Week 4, Week 12, Week 24, Week 52
Change in Patient Global Impression of Change (PGIC) scores
Time frame: Baseline (Day 0), Week 1, Week 4, Week 12, Week 24, Week 52
Change in EORTC QLQ-CIPN20 scores
Time frame: Baseline (Day 0), Week 1, Week 4, Week 12, Week 24, Week 52
Change in Numeric Rating Scale for pain (NRS) scores
Time frame: Baseline (Day 0), Week 1, Week 4, Week 12, Week 24, Week 52
Time-to-onset of paclitaxel-induced peripheral neuropathy (PIPN)
Time frame: Baseline (Day 0), Week 1, Week 4, Week 12, Week 24, Week 52
Cumulative paclitaxel dose
Time frame: Baseline (Day 0), Week 1, Week 4, Week 12, Week 24, Week 52
Dose reductions or delays due to neuropathy
Time frame: Baseline (Day 0), Week 1, Week 4, Week 12, Week 24, Week 52
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Jijun Xu, MD, PhD principal investigator
Case Comprehensive Cancer Center, Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing High Concentration Capsaicin Patch (HCCP) in people with Chemotherapy-induced Peripheral Neuropathy and CIPN - Chemotherapy-Induced Peripheral Neuropathy, run by Case Comprehensive Cancer 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 3 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: opening soon, as of the sponsor's last update on 22 Sep 2026. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jijun Xu, MD, PhD ((216) 444-4080, Xuj3@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in taxane-induced peripheral neuropathy due to HCCP patch (time frame: Baseline (Day 0), Week 1, Week 4, Week 12, Week 24, Week 52). 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 22 Sep 2026.