Peripheral Neuropathy Due to ChemotherapyEarly Phase 1NCT06744816
Exploring the Benefit of Topical Capsaicin in Treating Pain From Chemo-induced Peripheral Neuropathy: a Longitudinal Single Center Pilot Study
A Early Phase 1 study testing Qutenza Patch in people with Peripheral Neuropathy Due to Chemotherapy, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
To learn if topical capsaicin can help relieve pain from CIPN and improve gait (the pattern of walking) in patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Neuropathy Due to Chemotherapy
- What is being tested?
- Qutenza Patch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Dec 2025to 30 Nov 2027
- Phase
- Early Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants diagnosed with pain of the lower extremity from chronic (>90 days duration) CIPN (due to either vinca alkaloids, taxanes, bortezomib, thalidomide, platinum-based compounds), seen at MD Anderson Cancer Center
- Participants reporting baseline pain ≥ 4 (0-10 scale, NRS)
- Participants age 18+
- Participants who have completed chemotherapy within the last year at the time of enrollment.
Who cannot join
- Participants with cognitive dysfunction
- Participants with recent history (<6 months) of drug or alcohol abuse
- Participants with open skin lesion or undergoing antibiotic therapy for local for systemic infection
- Participants with allergies to capsaicin or adhesives
- Pregnant participants
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, 1 recruiting
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Saba Javed, MD, 713-792-9530, sjaved@mdanderson.org
Saba Javed, MD
About this study
To learn if topical capsaicin can help relieve pain from CIPN and improve gait (the pattern of walking) in patients.
Read the detailed description
Primary Objectives
- To assess changes in Gait (specifically looking at velocity) before and after use of topical capsaicin.
Secondary Objectives
- To assess Pain intensity numerical rating scale (NRS) scores in chemotherapy induced peripheral neuropathy (CIPN) participants before and after use of capsaicin 8% topical patch.
- To assess changes in quantitative sensory testing (QST) before and after use of topical capsaicin.
- To assess skin punch biopsy to compare the integrity of epidermal nerve fibers and Meissner's corpuscles (MC) in CIPN patients before and after use of topical capsaicin (optional).
- To assess pain tumor related neuropathy assessment scale (TNAS) before and after topical capsaicin
- To assess pain interference using the Brief Pain Inventory (BPI), before and after topical capsaicin
- To assess Patient Global Impression of Change (PGIC)
- To assess the rate of adverse events and tolerability of topical capsaicin as reported by participants
- Being tested
- Qutenza Patch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qutenza PatchDrug
Given topical
| Study group | Role | What they receive |
|---|---|---|
| Treatment with Qutenza Patch (Topical Capsaicin) | Experimental | Up to 4 topical capsaicin patches will be applied on your feet for 30 minutes. Receives: Drug: Qutenza Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and adverse events (AE)s
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Measured: Through study completion; an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
- Study start11 Dec 2025
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Neuropathy Due to ChemotherapyStudies of the same condition, open and under way.
- More trials run by M.D. Anderson 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
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Averitas Pharma, Inc.
- Responsible party
- Sponsor
- Investigators
- Saba Javed, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06744816
- Sponsor's protocol ID
- 2024-1601
- Other IDs
- NCI-2024-10413
- Status last verified
- Jun 2026
- First submitted
- 17 Dec 2024
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Benefit of Topical Capsaicin in Treating Pain From Chemo-induced Peripheral Neuropathy: a Longitudinal Single Center Pilot Study
- ClinicalTrials.gov ID
- NCT06744816
- Acronym / sponsor ID
- 2024-1601
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Averitas Pharma, Inc.
- Study start
- 11 Dec 2025 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 20 Dec 2024 (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.
To learn if topical capsaicin can help relieve pain from CIPN and improve gait (the pattern of walking) in patients.
Detailed description
Primary Objectives
- To assess changes in Gait (specifically looking at velocity) before and after use of topical capsaicin.
Secondary Objectives
- To assess Pain intensity numerical rating scale (NRS) scores in chemotherapy induced peripheral neuropathy (CIPN) participants before and after use of capsaicin 8% topical patch.
- To assess changes in quantitative sensory testing (QST) before and after use of topical capsaicin.
- To assess skin punch biopsy to compare the integrity of epidermal nerve fibers and Meissner's corpuscles (MC) in CIPN patients before and after use of topical capsaicin (optional).
- To assess pain tumor related neuropathy assessment scale (TNAS) before and after topical capsaicin
- To assess pain interference using the Brief Pain Inventory (BPI), before and after topical capsaicin
- To assess Patient Global Impression of Change (PGIC)
- To assess the rate of adverse events and tolerability of topical capsaicin as reported by participants
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment with Qutenza Patch (Topical Capsaicin) | Experimental | Drug: Qutenza PatchUp to 4 topical capsaicin patches will be applied on your feet for 30 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants diagnosed with pain of the lower extremity from chronic (>90 days duration) CIPN (due to either vinca alkaloids, taxanes, bortezomib, thalidomide, platinum-based compounds), seen at MD Anderson Cancer Center
- Participants reporting baseline pain ≥ 4 (0-10 scale, NRS)
- Participants age 18+
- Participants who have completed chemotherapy within the last year at the time of enrollment.
Key exclusion criteria (5 listed)
- Participants with cognitive dysfunction
- Participants with recent history (<6 months) of drug or alcohol abuse
- Participants with open skin lesion or undergoing antibiotic therapy for local for systemic infection
- Participants with allergies to capsaicin or adhesives
- Pregnant participants
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 |
|---|---|---|
| Qutenza PatchGiven topical | Drug | Treatment with Qutenza Patch (Topical Capsaicin) |
Primary outcome
Safety and adverse events (AE)s
Time frame: Through study completion; an average of 1 year
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
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 26 Jun 2026.
- MD Anderson Cancer CenterLink provided by the sponsor.
Related trials for Peripheral Neuropathy Due to Chemotherapy
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)
RecruitingEarly Phase 1
Neuroprotective Potential of Cannabidiol (CBD) in Preventing Oxaliplatin (Ox)-Induced Neuropathy
Oxaliplatin Induced Peripheral Neuropathy in Cancer Patients, Metastatic Colorectal Cancer (CRC)
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.
Saba Javed, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Qutenza Patch in people with Peripheral Neuropathy Due to Chemotherapy, run by M.D. Anderson 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 4 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: looking for participants now, as of the sponsor's last update on 26 Jun 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. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Saba Javed, MD (713-792-9530, sjaved@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and adverse events (AE)s (time frame: Through study completion; an average of 1 year). 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 26 Jun 2026.