Cryocompression to Reduce Chemotherapy-induced Peripheral Neuropathy in Gynecologic Cancer

NCT04563130 | Completed DMC

• 1 other identifier: Pro00106236
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Change in Patient Neurotoxicity Questionnaire [PNQ] (patient reported assessment) over time

  PNQ is a patient-reported questionnaire that consists of 2 items, representing motor and sensory components, with increasing grades for worsening symptoms. Patients will respond to each question for each of their 4 extremities by grading sensory and motor symptoms as A (no neuropathy), B (mild neuropathy), C (moderate neuropathy that does not interfere with activities of daily living \[ADL\]), D (moderate neuropathy that does interfere with ADL), or E (severe neuropathy that interferes with ADL). The first primary outcome of this study is the proportion of patients with Patient Neurotoxicity Questionnaire (PNQ) grade C or higher peripheral sensory neuropathy any time after the baseline assessment.

  baseline, after each dose of paclitaxel and cryocompression, and one month after completion of chemotherapy.

• Change in Semmes-Weinstein monofilament test (tactile disturbance) over time

  The monofilament test is a simple, inexpensive test to assess tactile sensation and detect peripheral sensory neuropathy. Tactile perception is assessed at 10 locations on the hand and 10 locations on the foot. Patients who exhibit any decline in tactile sensitivity in response to light touch from baseline to completion of taxane treatment will be counted as events for the primary outcome assessment.

  baseline, one month after completion of chemotherapy.

Secondary Outcomes (3)

• Change in Functional Assessment of Cancer Therapy (FACT) -Taxane [FACT-NTX] (patient reported assessment) over time

  baseline, after each dose of paclitaxel and cryocompression, and one month after completion of chemotherapy.

• Tolerability of cryocompression: scale

  after each dose of paclitaxel and cryocompression

• Acceptability: scale

  immediately after the intervention

Study Arms (2)

Cryocompression

EXPERIMENTAL

Patients will be randomized to receive cryocompression on one hand and foot using ice bags and compression socks.

Behavioral: Cryocompression

Control

NO INTERVENTION

Patients will be randomized to receive no intervention on the opposite hand and foot.

Interventions

Cryocompression BEHAVIORAL

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

Cryocompression

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Gynecologic cancer diagnosis (ovarian, cervical, endometrial cancer; adenocarcinomas of likely primary gynecologic origin based on cytology or FNA in conjunction with radiologic impression will be eligible)
• Plan to receive at least 6 cycles of paclitaxel administered every 3 weeks at Duke Cancer Institute. Patients receiving neoadjuvant chemotherapy with a plan for interval debulking will be eligible.
• ECOG performance status of 0-1
• Latex allergy does not exclude a subject from the study. Non-latex gloves will be provided.

You may not qualify if:

• Treated with prior neurotoxic chemotherapeutic agents
• Baseline diagnosis of peripheral neuropathy such as diabetic neuropathy, or associated with conditions including but not limited to fibromyalgia, cryoglobulinemia and Raynaud's disease.

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

• Anastasio MK, Unnithan S, Scott A, Hayes T, Shah S, Moss HA, Erkanli A, Havrilesky LJ. Cryocompression to Reduce Peripheral Neuropathy in Gynecologic Cancer: A Randomized Controlled Trial. Obstet Gynecol. 2023 Dec 1;142(6):1459-1467. doi: 10.1097/AOG.0000000000005419. Epub 2023 Oct 26.

  PMID: 37883997 DERIVED

Study Officials

• Laura Havrilesky, MD, MHSc

  Duke University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2020
• First Posted: September 24, 2020
• Study Start: January 11, 2021
• Primary Completion: November 17, 2022
• Study Completion: October 26, 2023
• Last Updated: November 13, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)