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Cryocompression to Reduce Chemotherapy-induced Peripheral Neuropathy in Gynecologic Cancer

NCT04563130 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 91

Last updated 2023-11-13

No results posted yet for this study

Summary

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.

Conditions

  • Gynecologic Cancer
  • Chemotherapy-induced Peripheral Neuropathy

Interventions

BEHAVIORAL

Cryocompression

Cryocompression will be administered using ice bags and compression socks/ surgical gloves

Sponsors & Collaborators

Principal Investigators

  • Laura Havrilesky, MD, MHSc · Duke University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-01-11
Primary Completion
2022-11-17
Completion
2023-10-26

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04563130 on ClinicalTrials.gov