Trial · NCT01855607
Topical Menthol for the Treatment of Chemotherapy Induced Peripheral Neuropathy
NCT01855607, Phase 2, Terminated, Columbia University; results first posted 2024-07-11
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Topical Menthol for the Treatment of Chemotherapy Induced Peripheral Neuropathy. Trials, record NCT01855607. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01855607
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Topical Menthol for the Treatment of Chemotherapy Induced Peripheral Neuropathy
- NCT number
- NCT01855607
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 12 participants, actual
- Lead sponsor
- Columbia University
- Conditions
- Breast Cancer, Colon Cancer, Neuropathy
- Interventions
- topical menthol, placebo lotion
- First posted
- 2013-05-16
- Last updated
- 2024-07-11
- Results first posted
- 2024-07-11
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Brief Pain Inventory-Short Form Score | 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. |
| Secondary | Change in EORTC-CIPN20 Score | Baseline and 6 weeks | 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. |
| Secondary | Change in Sensorimotor Function | Baseline and 6 weeks | 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. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Brief Pain Inventory-Short Form Score | Baseline and 6 weeks | The study was terminated due to poor enrollment; no data was collected from participants. Participants were not randomized, therefore results are reported as a combined total and cannot be presented per Arm. | ||
| SECONDARY | Change in EORTC-CIPN20 Score | Baseline and 6 weeks | The study was terminated due to poor enrollment; no data was collected from participants. Participants were not randomized, therefore results are reported as a combined total and cannot be presented per Arm. | ||
| SECONDARY | Change in Sensorimotor Function | Baseline and 6 weeks | The study was terminated due to poor enrollment; no data was collected from participants. Participants were not randomized, therefore results are reported as a combined total and cannot be presented per Arm. |
Source ClinicalTrials.gov
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | All Participants | 12 | |
| Overall Study | COMPLETED | All Participants | 0 | |
| Overall Study | NOT COMPLETED | All Participants | 12 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | All Participants | 0 | 11 |
| Total, other adverse events | All Participants | 0 | 11 |
| Total, serious adverse events | All Participants | 0 | 11 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01855607
GET https://conductscience.org/api/trials/v1/NCT01855607/registered