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Recruiting NCT06139458

Cryocompression to Reduce Chemotherapy-induced Peripheral Neuropathy in Gynecologic Cancer - COHORT 2

No phase Interventional Gynecologic Cancer Chemotherapy-induced Peripheral Neuropathy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cryotherapy, Compression.
Who it may be relevant to
Registry conditions: Gynecologic Cancer, Chemotherapy-induced Peripheral Neuropathy. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Use of Cryocompression to Reduce Chemotherapy-induced Peripheral Neuropathy in Gynecologic Cancer: a Randomized Controlled Trial - COHORT 2

Overview

The investigators aim to determine the effect of cryotherapy wraps plus compression therapy (henceforth referred to as cryocompression) versus cryotherapy wraps alone on the incidence and degree of chemotherapy-induced peripheral neuropathy in patients with gynecologic cancer using a noninferiority design. The investigators also aim to determine the effect of cryocompression versus cryotherapy on patient tolerability and patient and staff satisfaction.

Detailed description

Participants will be randomized by patient to receive cryotherapy wraps plus compression therapy (cryocompression) versus cryotherapy wraps alone applied to the bilateral hands and feet. Participants will receive cryotherapy (+/- compression) for the duration of their taxane infusions. Participants will be asked to complete the FACT-NTX survey and a PNQ neuropathy surveys at each infusion visit to evaluate symptoms related to neuropathy. Participants will also complete a brief acceptability and tolerability survey at each visit. Lastly, a staff satisfaction survey will be administered at each visit as well. The investigators will test the hypothesis that the average final visit FACT-NTX11 scores in the cryotherapy group are noninferior to the cryocompression group with a noninferiority margin of 2.5 points. The investigators will routinely monitor for the following adverse events: frost bite, (unexpected) hospitalizations, and death.

Interventions

  • Behavioral Cryotherapy
    Participants will receive cryotherapy on both hands and feet
  • Behavioral Compression
    Participants will receive compression on both hands and feet

Primary outcome measures

  • Change in Functional Assessment of Cancer Therapy (FACT) -Taxane [FACT-NTX] (patient reported assessment) over time [Time frame: Up to two months after completion of chemotherapy, an average of 6 months]
Secondary outcome measures (5)
  • Tolerability of cryocompression: scale [Time frame: Up to two months after completion of chemotherapy, an average of 6 months]
  • Acceptability: scale [Time frame: Up to two months after completion of chemotherapy, an average of 6 months]
  • Measure of manageability and acceptability for staff involved in the participants' care [Time frame: Up to two months after completion of chemotherapy, an average of 6 months]
  • Change in Patient Neurotoxicity Questionnaire [PNQ] (patient reported assessment) over time [Time frame: Up to two months after completion of chemotherapy, an average of 6 months]
  • Chemotherapy Dose [Time frame: Up to two months after completion of chemotherapy, an average of 6 months]

Eligibility criteria

Inclusion criteria

  • 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 the Duke Cancer Center or Macon Pond or at the Carilion Clinic in Roanoke, VA. Patients receiving neoadjuvant chemotherapy with a plan for interval debulking will be eligible.
  • ECOG (Eastern Cooperative Oncology Group) performance status of 0-1

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 4 centers
  • Hartford Healthcare Cancer Institute — Hartford
  • Middlesex Health Cancer Center - Middletown — Middletown
  • Duke University Medical Center — Durham
  • Carilion Clinic — Roanoke

Identifiers

NCT: NCT06139458 · Pro00106236_1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗