# Cryotherapy and Compression Therapy to Prevent Chemotherapy Induced Peripheral Neuropathy in Breast Cancer Patients

> **NIH NIH R03** · COLUMBIA UNIVERSITY HEALTH SCIENCES · 2021 · $81,000

## Abstract

Due to major advances in early detection and improved therapies, patients with breast cancer (BC) are living
longer. Unfortunately, many BC therapies are known to carry a substantial risk of adverse long-term effects. One
of the most common and debilitating adverse effects is chemotherapy-induced peripheral neuropathy (CIPN),
which is associated with widely used anti-breast cancer drugs such as taxane chemotherapy. CIPN is difficult to
prevent and to treat. Many pharmacologic therapies have been evaluated including antidepressants,
anticonvulsants, analgesics, and supplements; unfortunately, all studies, except for a phase III evaluation of
duloxetine, have demonstrated no improvement or even worsening of CIPN symptoms, and no effective
prevention strategy has been identified. A few small, non-randomized studies in which patients served as their
own controls, suggest a possible benefit of cryotherapy or compression therapy on prevention of CIPN
symptoms. We will conduct a phase IIB randomized trial of up to 100 subjects (60-70 subjects expected under
most likely scenarios) with early stage BC during treatment with taxane chemotherapy. Participants will be
randomized to either cryotherapy, compression therapy, or placebo. The primary goal of this study is to select
the best intervention to be carried forward to a larger phase III trial, with a high probability of a correct selection
if one intervention is truly superior to the other using a pre-specified effect size. Our aims are to (1) to identify a
preferred therapy between cryotherapy delivered via frozen gloves and socks, compression therapy delivered
via compression gloves and socks, or placebo (“loose” gloves and socks) at prevention of patient reported CIPN
symptoms after 12 weeks of therapy. We will define success as a change in the FACT NTX questionnaire of <5
from baseline to 12-week evaluation; (2) To evaluate the effect of cryotherapy, compression therapy, and
placebo on objective sensory and motor functional tests. We will compare changes from baseline to 12-weeks
with the tuning fork, Neuropen, timed get up and go test, and tandem/unipedal stance test. To date, we have not
been successful at treating or preventing CIPN. This study evaluates the use of promising and readily available,
non-pharmacologic, and low cost interventions aimed at prevention of CIPN. If found beneficial, these treatments
may bring us one step closer to improving the lives of cancer survivors.

## Key facts

- **NIH application ID:** 10069322
- **Project number:** 5R03CA238982-02
- **Recipient organization:** COLUMBIA UNIVERSITY HEALTH SCIENCES
- **Principal Investigator:** Melissa Accordino
- **Activity code:** R03 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $81,000
- **Award type:** 5
- **Project period:** 2019-12-10 → 2021-11-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10069322

## Citation

> US National Institutes of Health, RePORTER application 10069322, Cryotherapy and Compression Therapy to Prevent Chemotherapy Induced Peripheral Neuropathy in Breast Cancer Patients (5R03CA238982-02). Retrieved via AI Analytics 2026-06-11 from https://api.ai-analytics.org/grant/nih/10069322. Licensed CC0.

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