Breast Cancer, Colon Cancer, Neuropathy
Conditions
Keywords
chemotherapy induced neuropathy
Brief 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 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
Interventions
DRUGtopical menthol
7.5% Methylsalicylate / 2% Menthol Lotion
DRUGplacebo lotion
The control (placebo) product has same amount of Methylsalicylate (7.5%) and no menthol.
Sponsors
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age≥21 years 2. History of stage I-III breast, gastrointestinal or gynecologic cancer 3. Must have received at least one taxane or platinum based chemotherapy drug within two years prior to enrollment. 4. 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. 5. Signed informed consent 6. Concomitant biologic, hormonal, or radiation therapy are acceptable 7. 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
Exclusion criteria
1. Previous treatment with topical menthol (menthol/methylsalicylate products like BenGay, Aspercreme, or Icy Hot) of any concentration within the previous 3 months 2. Known diabetic neuropathy 3. Severe concomitant illnesses 4. Known allergy or preexisting skin disease which prohibits use of menthol 5. Any topical treatment for neuropathy or other serious skin condition on the hands or feet.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
Participant flow
Pre-assignment details
The study was terminated before randomization could be assigned, therefore all participant data is presented as a combined total and cannot be presented per Arm.
Participants by arm
| Arm | Count |
|---|---|
| All Participants Patients with neuropathic pain will receive topical menthol or placebo lotion following or during chemotherapy for the treatment of either breast, gastrointestinal, or gynecologic cancer.
Topical menthol: 7.5% Methylsalicylate and 2% Menthol Lotion
Placebo lotion: 7.5% Methylsalicylate and no menthol. | 11 |
| Total | 11 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Study was terminated | 11 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 4 Participants |
| Region of Enrollment United States | 11 participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 11 |
| other Total, other adverse events | 0 / 11 |
| serious Total, serious adverse events | 0 / 11 |
Outcome results
Primary
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.
Time frame: Baseline and 6 weeks
Population: 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
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.
Time frame: Baseline and 6 weeks
Population: 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
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.
Time frame: Baseline and 6 weeks
Population: 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.