Clinical trial NCT03873272: The CONTRoL Trial: Cryotherapy vs. cOmpression Neuropathy TRiaL
Official title: Randomized Controlled Selection Trial of Cryotherapy vs. Compression Therapy for the Prevention of Taxane-induced Peripheral Neuropathy in Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: CIPN - Chemotherapy-Induced Peripheral Neuropathy
Keywords: Neuropathy
CIPN
Cryotherapy
Compression therapy
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2019-03-13
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: The preferred intervention can be selected during the ongoing enrollment as soon as the pre-specified selection criteria are met, and further enrollment will cease.
Primary purpose: PREVENTION

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.

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)

Primary outcomes:
measure: Proportion of Patients With Successful Outcomes (<5-point Decrease in FACT-NTX From Baseline)
timeFrame: Baseline, 12 weeks
Secondary outcomes:
measure: Change in NCI-CTCAE Grade for CIPN
timeFrame: Baseline, 12, and 24 weeks
measure: Change in Nail Toxicity
timeFrame: Baseline, 12 weeks, 24 weeks
measure: Comfort With Intervention Scale Score
timeFrame: Up to 24 weeks
measure: Vibration Perception and Disappearance Threshold
timeFrame: Up to 24 weeks
measure: Subjects Perceived Pain and Pressure Using Neuropen Test
timeFrame: Up to 24 weeks
measure: Average Time to Complete 'Timed Get up and go' Test
timeFrame: Up to 24 weeks
measure: Tandem and Unipedal Stance Test
timeFrame: Up to 24 weeks
measure: Adherence to Study Intervention
timeFrame: Up to 24 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Melissa Accordino, MD
role: PRINCIPAL_INVESTIGATOR
References: