Breast CancerPhase 2NCT01855607
Topical Menthol for the Treatment of Chemotherapy Induced Peripheral Neuropathy
A Phase 2 study testing topical menthol in people with Breast Cancer and Colon Cancer, run by Columbia University at 1 site in United States.
Trial summary
Primary Objective: To assess whether six-week treatment with twice daily topical Menthol application will decrease neuropathic pain as measured by the change in Brief Pain Inventory-Short Form (BPI-SF worst pain score), following or during neoadjuvant/adjuvant chemotherapy with taxane or platinum-based regimens among… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Breast Cancer, Colon Cancer, Neuropathy
- What is being tested?
- topical menthol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Nov 2016
- Phase
- Phase 2
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age≥21 years
- History of stage I-III breast, gastrointestinal or gynecologic cancer
- Must have received at least one taxane or platinum based chemotherapy drug within two years prior to enrollment.
- Must exhibit a typical symptom of CIPN that was not present prior to chemotherapy. Symptoms include numbness, tingling, thermal hyperalgesia, cold allodynia in the hands and/or feet, muscle weakness or unsteady gait in at least two of the last seven days prior to registration.
- Signed informed consent
- Concomitant biologic, hormonal, or radiation therapy are acceptable
- Narcotics, antidepressants or other medications for the treatment of CIPN are permitted, if patient on a stable dose for at least one month prior to enrollment
Who cannot join
- Previous treatment with topical menthol (menthol/methylsalicylate products like BenGay, Aspercreme, or Icy Hot) of any concentration within the previous 3 months
- Known diabetic neuropathy
- Severe concomitant illnesses
- Known allergy or preexisting skin disease which prohibits use of menthol
- Any topical treatment for neuropathy or other serious skin condition on the hands or feet.
Trial locations and contacts
1 site in 1 country.
United States1 site
Herbert Irving Comprehensive Cancer Center
New York, New York, 10032
About this study
Official title: Topical Menthol for Chemotherapy Induced Peripheral Neuropathy (CIPN): A Randomized, Placebo Controlled Phase II Trial
Primary Objective: To assess whether six-week treatment with twice daily topical Menthol application will decrease neuropathic pain as measured by the change in Brief Pain Inventory-Short Form (BPI-SF worst pain score), following or during neoadjuvant/adjuvant chemotherapy with taxane or platinum-based regimens among breast, gastrointestinal or gynecologic cancer patients.
Secondary objectives:
- To compare change in patient-reported outcomes: overall BPI-SF scales, EORTC-CIPN20, European Organization for Research and Treatment of Cancer Chemotherapy Quality of Life Questionnaire (EORTC QLQ-C30), Patient-Reported Outcomes Measurement Information System (PROMIS-29) scores between study groups.
- To compare changes in dose delivery and early treatment discontinuation rates between study groups.
- To compare objective sensory and motor functional change from baseline with the use of quantitative neurosensory testing.
- To perform an exploratory analysis evaluating the interaction between treatment and chemotherapy type.
Read the detailed description
Chemotherapy induced peripheral neuropathy (CIPN): CIPN is a debilitating and often irreversible toxicity associated with various chemotherapy agents widely used in the treatment of both solid tumors and hematologic malignancies. Clinical trials with Taxane-based forms of chemotherapy, commonly used in the adjuvant treatment of breast cancer, have reported up to 33% grades 2-3 sensory neuropathy and up to 14% of motor neuropathy. Severity is closely related to chemotherapy dose and schedule. CIPN may also develop in up to 64% of patients treated with 12 cycles of Oxaliplatin based adjuvant chemotherapy, when assessed clinically and electro physiologically. Patients develop an axonal, predominately sensory peripheral neuropathy, of mild to moderate severity. Thermal hyperalgesia with cold allodynia was found to be a clinical marker of early oxaliplatin neurotoxicity and may predict severe neuropathy
- Conditions
- Breast Cancer, Colon Cancer, Neuropathy
- Being tested
- topical menthol, placebo lotion
- Keywords
- chemotherapy induced neuropathy
- Medical subject headings
- Breast Neoplasms, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
topical mentholDrug
Also called RX-116
7.5% Methylsalicylate / 2% Menthol Lotion
placebo lotionDrug
Also called RX-115
The control (placebo) product has same amount of Methylsalicylate (7.5%) and no menthol.
| Study group | Role | What they receive |
|---|---|---|
| topical menthol | Experimental | Patients with neuropathic pain will receive topical menthol following or during chemotherapy for the treatment of either breast, gastrointestinal, or gynecologic cancer. Receives: Drug: topical menthol |
| placebo lotion | Active comparator | Patients with neuropathic pain will receive placebo lotion following or during chemotherapy for the treatment of either breast, gastrointestinal, or gynecologic cancer. Receives: Drug: placebo lotion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Brief Pain Inventory-Short Form Score
The Brief Pain Inventory-Short Form (BPI-SF) is a well-validated clinical tool used frequently to assess severity of pain and its effect on daily functions in patients with neuropathy. The instrument gives several ratings of the intensity and severity of pain and the degree of pain interference on activity, mood, sleep, relations with others and work. The questionnaire uses a 0-10 scale with a higher score indicating a worse outcome.
Measured: Baseline and 6 weeks
Secondary outcomes (2)
Change in EORTC-CIPN20 Score
The European Organization for Research and Treatment of Cancer Chemotherapy-induced peripheral neuropathy (EORTC-CIPN20) is a questionnaire measuring patient reported symptoms of chemotherapy induced neuropathy. Scores range from 20-80 with a higher score indicating a worse outcome.
Measured: Baseline and 6 weeks
Change in Sensorimotor Function
Sensorimotor function as measured by a Bio-Thesiometer, which measures changes in vibratory perception. The Bio-Thesiometer is an electrical tuning fork whose amplitude can be gradually increased. Vibration threshold will be assessed at the dorsum of the distal interphalangeal joint of the index finger and dorsum of the interphalangeal joint of the hallux. Subjects will be asked to indicate when the vibration stimulus is initially felt (perception threshold) and when the stimulus disappears (disappearance threshold.) The vibration perception threshold is the average of three paired measurements.
Measured: Baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2013 (estimated)
- Study startAug 2013
- Primary completionNov 2016
- Study completionNov 2016
Why it stopped: Poor enrollment
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 Breast CancerStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dawn L. Hershman, Columbia University
- Investigators
- Dawn Hershman, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01855607
- Sponsor's protocol ID
- AAAL2664
- Status last verified
- Oct 2022
- First submitted
- 14 May 2013
- Last updated
- 11 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Menthol for Chemotherapy Induced Peripheral Neuropathy (CIPN): A Randomized, Placebo Controlled Phase II Trial
- ClinicalTrials.gov ID
- NCT01855607
- Acronym / sponsor ID
- AAAL2664
- Conditions
- Breast Cancer, Colon Cancer, Neuropathy
- Keywords
- chemotherapy induced neuropathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor enrollment
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- Aug 2013 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 16 May 2013 (estimated)
- Results
- Posted 11 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Objective: To assess whether six-week treatment with twice daily topical Menthol application will decrease neuropathic pain as measured by the change in Brief Pain Inventory-Short Form (BPI-SF worst pain score), following or during neoadjuvant/adjuvant chemotherapy with taxane or platinum-based regimens among breast, gastrointestinal or gynecologic cancer patients.
Secondary objectives:
- To compare change in patient-reported outcomes: overall BPI-SF scales, EORTC-CIPN20, European Organization for Research and Treatment of Cancer Chemotherapy Quality of Life Questionnaire (EORTC QLQ-C30), Patient-Reported Outcomes Measurement Information System (PROMIS-29) scores between study groups.
- To compare changes in dose delivery and early treatment discontinuation rates between study groups.
- To compare objective sensory and motor functional change from baseline with the use of quantitative neurosensory testing.
- To perform an exploratory analysis evaluating the interaction between treatment and chemotherapy type.
Detailed description
Chemotherapy induced peripheral neuropathy (CIPN): CIPN is a debilitating and often irreversible toxicity associated with various chemotherapy agents widely used in the treatment of both solid tumors and hematologic malignancies. Clinical trials with Taxane-based forms of chemotherapy, commonly used in the adjuvant treatment of breast cancer, have reported up to 33% grades 2-3 sensory neuropathy and up to 14% of motor neuropathy. Severity is closely related to chemotherapy dose and schedule. CIPN may also develop in up to 64% of patients treated with 12 cycles of Oxaliplatin based adjuvant chemotherapy, when assessed clinically and electro physiologically. Patients develop an axonal, predominately sensory peripheral neuropathy, of mild to moderate severity. Thermal hyperalgesia with cold allodynia was found to be a clinical marker of early oxaliplatin neurotoxicity and may predict severe neuropathy
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| topical menthol | Experimental | Drug: topical mentholPatients with neuropathic pain will receive topical menthol following or during chemotherapy for the treatment of either breast, gastrointestinal, or gynecologic cancer. |
| placebo lotion | Active comparator | Drug: placebo lotionPatients with neuropathic pain will receive placebo lotion following or during chemotherapy for the treatment of either breast, gastrointestinal, or gynecologic cancer. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age≥21 years
- History of stage I-III breast, gastrointestinal or gynecologic cancer
- Must have received at least one taxane or platinum based chemotherapy drug within two years prior to enrollment.
- Must exhibit a typical symptom of CIPN that was not present prior to chemotherapy. Symptoms include numbness, tingling, thermal hyperalgesia, cold allodynia in the hands and/or feet, muscle weakness or unsteady gait in at least two of the last seven days prior to registration.
- Signed informed consent
Key exclusion criteria (5 listed)
- Previous treatment with topical menthol (menthol/methylsalicylate products like BenGay, Aspercreme, or Icy Hot) of any concentration within the previous 3 months
- Known diabetic neuropathy
- Severe concomitant illnesses
- Known allergy or preexisting skin disease which prohibits use of menthol
- Any topical treatment for neuropathy or other serious skin condition on the hands or feet.
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 |
|---|---|---|
| topical mentholAlso: RX-1167.5% Methylsalicylate / 2% Menthol Lotion | Drug | topical menthol |
| placebo lotionAlso: RX-115The control (placebo) product has same amount of Methylsalicylate (7.5%) and no menthol. | Drug | placebo lotion |
Primary outcome
Change in Brief Pain Inventory-Short Form Score
Time frame: Baseline and 6 weeks
The Brief Pain Inventory-Short Form (BPI-SF) is a well-validated clinical tool used frequently to assess severity of pain and its effect on daily functions in patients with neuropathy. The instrument gives several ratings of the intensity and severity of pain and the degree of pain interference on activity, mood, sleep, relations with others and work. The questionnaire uses a 0-10 scale with a higher score indicating a worse outcome.
2 secondary outcomes
Change in EORTC-CIPN20 Score
Time frame: Baseline and 6 weeks
Change in Sensorimotor Function
Time frame: Baseline and 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
Dawn Hershman, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing topical menthol in people with Breast Cancer and Colon Cancer, run by Columbia University 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 7 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: stopped early, as of the sponsor's last update on 11 Jul 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jul 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?
Change in Brief Pain Inventory-Short Form Score (time frame: Baseline and 6 weeks). 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 11 Jul 2024.