NCT04563130

Cryocompression to Reduce Chemotherapy-induced Peripheral Neuropathy in Gynecologic Cancer

Completed NA Last updated 13 November 2023

What this trial tests

NA trial testing Cryocompression in Gynecologic Cancer in 91 participants. Completed in 26 October 2023.

Timeline

11 January 2021

Primary endpoint
17 November 2022

26 October 2023

Quick facts

Lead sponsor	Duke University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	91
Start date	11 January 2021
Primary completion	17 November 2022
Estimated completion	26 October 2023
Sites	1 location across United States

Drugs / interventions tested

• Cryocompression

Conditions studied

• Gynecologic Cancer — all drugs for Gynecologic Cancer →
• Chemotherapy-induced Peripheral Neuropathy — all drugs for Chemotherapy-induced Peripheral Neuropathy →

Sponsor

Duke University

Who can join

Eligibility, female only, with Gynecologic Cancer or Chemotherapy-induced Peripheral Neuropathy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The aim of this study is to evaluate the effect of cryocompression therapy on the incidence and degree of taxane-induced peripheral neuropathy in gynecologic cancer patients receiving chemotherapy. Subjects will serve as their own controls, and will be randomized to cryocompression therapy on their dominant versus non-dominant hand and foot, with standard of care treatment (no intervention) on the opposite hand and foot. Compression therapy will be performed using commercially available compression socks and disposable surgical gloves, and cryotherapy will be achieved by applying bags of ice to the compression devices. Subjects will complete baseline neuropathy surveys including the Patient Neurotoxicity Questionnaire (PNQ) and the Functional Assessment of Cancer Therapy (FACT) -Taxane (FACT-NTX), which includes the sensory subscale of the FACT-NTX. Subjective symptoms will be assessed at baseline, before each cycle of chemotherapy and cryocompression, and one month after completion of 6 cycles. In addition, tactile sensation will be assessed with the monofilament test at baseline and one month after completion of 6 cycles of chemotherapy and cryocompression. The primary outcomes are the proportion of patients with PNQ grade C or higher and decline in tactile sensitivity from baseline based on the monofilament test. The investigators hypothesize that cryocompression will reduce chemotherapy-induced peripheral neuropathy in patients with gynecologic cancer.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Cryocompression to Reduce Peripheral Neuropathy in Gynecologic Cancer: A Randomized Controlled Trial.
   Anastasio MK, Unnithan S, Scott A, Hayes T, et al · · 2023 · cited 2× · PMID 37883997 · DOI 10.1097/aog.0000000000005419