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07-12-2023 | Cryotherapy | Clinical trial

Randomized adaptive selection trial of cryotherapy, compression therapy, and placebo to prevent taxane-induced peripheral neuropathy in patients with breast cancer

Authors: Melissa K. Accordino, Shing Lee, Cheng Shiun Leu, Bruce Levin, Meghna S. Trivedi, Katherine D. Crew, Kevin Kalinsky, Rohit Raghunathan, Khadija Faheem, Erik Harden, Alessandra Taboada, Beatriz Desanti de Oliveira, Elisabeth Larson, Lauren Franks, Erin Honan, Cynthia Law, Dawn L. Hershman

Published in: Breast Cancer Research and Treatment | Issue 1/2024

Abstract

Background

Chemotherapy-induced peripheral neuropathy (CIPN) is a common and debilitating adverse effect of taxane therapy. Small non-randomized studies in patients with early-stage breast cancer (ESBC) suggest both cryotherapy and compression therapy may prevent CIPN. It is unknown which is more effective.

Methods

We conducted a randomized phase IIB adaptive sequential selection trial of cryotherapy vs. compression therapy vs. placebo (“loose” gloves/socks) during taxane chemotherapy. Participants were randomized in triplets. Garments were worn for 90–120 min, beginning 15 min prior and continuing for 15 min following the infusion. The primary goal was to select the best intervention based on a Levin–Robbins–Leu sequential selection procedure. The primary endpoint was a < 5-point decrease in the Functional Assessment of Cancer Therapy Neurotoxicity (FACT-NTX) at 12 weeks. An arm was eliminated if it had four or more fewer successes than the currently leading arm. Secondary endpoints included intervention adherence and patient-reported comfort/satisfaction.

Results

Between April 2019 and April 2021, 63 patients were randomized (cryotherapy (20); compression (22); placebo (21)). Most patients (60.3%) were treated with docetaxel. The stopping criterion was met after the 17th triplet (n = 51) was evaluated; success at 12 weeks occurred in 11 (64.7%) on compression therapy, 7 (41.1%) on cryotherapy, and 7 (41.1%) on placebo. Adherence to the intervention was lowest with cryotherapy (35.0%) compared to compression (72.7%) and placebo (76.2%).

Conclusion

Compression therapy was the most effective intervention in this phase IIB selection trial to prevent CIPN and was well tolerated. Compression therapy for the prevention of CIPN should be evaluated in a phase III study.

Clinical trial registration

ClinicaTrials.gov Identifier: NCT03873272.

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Title: Randomized adaptive selection trial of cryotherapy, compression therapy, and placebo to prevent taxane-induced peripheral neuropathy in patients with breast cancer
Authors: Melissa K. Accordino
Shing Lee
Cheng Shiun Leu
Bruce Levin
Meghna S. Trivedi
Katherine D. Crew
Kevin Kalinsky
Rohit Raghunathan
Khadija Faheem
Erik Harden
Alessandra Taboada
Beatriz Desanti de Oliveira
Elisabeth Larson
Lauren Franks
Erin Honan
Cynthia Law
Dawn L. Hershman
Publication date: 07-12-2023
Publisher: Springer US
Keywords: Cryotherapy
Cryotherapy
Cytostatic Therapy
Breast Cancer
Breast Cancer
Published in: Breast Cancer Research and Treatment / Issue 1/2024
Print ISSN: 0167-6806
Electronic ISSN: 1573-7217
DOI: https://doi.org/10.1007/s10549-023-07172-y

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Abstract

Background

Methods

Results

Conclusion

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