Randomized Controlled Selection Trial of Cryotherapy vs. Compression Therapy for the Prevention of Taxane-induced Peripheral Neuropathy in Breast Cancer Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- CIPN - Chemotherapy-Induced Peripheral Neuropathy
- Sponsor
- Columbia University
- Enrollment
- 63
- Locations
- 1
- Primary Endpoint
- Proportion of Patients With Successful Outcomes (<5-point Decrease in FACT-NTX From Baseline)
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
The primary objective of this study is to select the best intervention from cold therapy, compression therapy and placebo at reducing neuropathic pain as measured by the change in the Neurotoxicity (NTX) component of the Functional Assessment of Cancer Therapy (FACT) - Taxane questionnaire, following 12 weeks of neoadjuvant/adjuvant chemotherapy with paclitaxel or docetaxel among breast cancer patients.
Detailed Description
Chemotherapy-induced peripheral neuropathy (CIPN) is a frequent side effect resulting from the administration of cytotoxic chemotherapeutic agents. The incidence of CIPN can vary on the type of agent used, the frequency with which it is given, and the cumulative dose. Unfortunately, for some patients, symptoms may persist even after discontinuation of the drug due to irreversible nerve damage. As of now, there are no established agents for CIPN prevention. This is a randomized, placebo-controlled clinical selection trial of interventions for CIPN in patients treated with docetaxel every 3 weeks or paclitaxel on a weekly schedule. Patients will be randomly assigned to receive either frozen gloves and socks, compression gloves and socks, or "loose" gloves and socks (placebo arm) during chemotherapy infusion to study the best intervention at reducing neuropathic pain.
Investigators
Melissa K Accordino
Assistant Professor of Medicine
Columbia University
Eligibility Criteria
Inclusion Criteria
- •Age greater or equal to 18 years.
- •History of stage I-III breast cancer
- •Patient scheduled to be receiving adjuvant or neoadjuvant paclitaxel or docetaxel for at least 12 weeks
- •Signed informed consent
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤2 (Karnofsky ≥60%,)
Exclusion Criteria
- •Prior treatment with taxane or platinum based chemotherapy
- •Known history of neuropathy
- •Raynaud's phenomenon
- •Peripheral arterial ischemia
- •Cold intolerance
- •Current use of duloxetine which may mitigate chemotherapy-induced peripheral neuropathy (CIPN)
Outcomes
Primary Outcomes
Proportion of Patients With Successful Outcomes (<5-point Decrease in FACT-NTX From Baseline)
Time Frame: Baseline, 12 weeks
The primary endpoint is the change in FACT NTX at 12 weeks from the start of chemotherapy. The change in FACT NTX will be dichotomized into a good outcome (change in FACT NTX less than 5 from baseline to week 12) versus a poor outcome (change in FACT NTX greater than or equal to 5 from baseline to week 12). The FACT-NTX subscale includes 11 items, each of which is divided into 5 scoring levels: 0, 1, 2, 3, 4, and a total score of 44. The scale is graded 0-4. A low score indicates a good effect. This change in FACT-NTX scale score indicates the proportion of patients with successful outcomes.
Secondary Outcomes
- Change in NCI-CTCAE Grade for CIPN(Baseline, 12, and 24 weeks)
- Change in Nail Toxicity(Baseline, 12 weeks, 24 weeks)
- Comfort With Intervention Scale Score(Up to 24 weeks)
- Vibration Perception and Disappearance Threshold(Up to 24 weeks)
- Subjects Perceived Pain and Pressure Using Neuropen Test(Up to 24 weeks)
- Average Time to Complete 'Timed Get up and go' Test(Up to 24 weeks)
- Tandem and Unipedal Stance Test(Up to 24 weeks)
- Adherence to Study Intervention(Up to 24 weeks)