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NCT04563130 · ClinicalTrials.gov registry record · NA
Cryocompression to Reduce Chemotherapy-induced Peripheral Neuropathy in Gynecologic Cancer
A NA study, sponsored by Duke University.
- Completed
- Registry status
- NA
- Development phase
- 91
- Enrollment target
NCT04563130 is a NA study that has completed, run by Duke University. The registered enrollment target is 91 participants.
The verdict
NCT04563130, a NA study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- NA
- Development phase
- 91 participants
- Enrollment target
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.
Interventions
- BEHAVIORAL Cryocompression
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 91 participants |
| Start Date | 2021-01-11 |
| Est. Completion | 2023-10-26 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04563130
The ClinicalTrials.gov registry entry for NCT04563130 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 91 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Cryocompression is the first listed.
NCT04563130 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04563130 about?
NCT04563130 is a clinical study titled "Cryocompression to Reduce Chemotherapy-induced Peripheral Neuropathy in Gynecologic Cancer". 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 ...
What is the current status of trial NCT04563130?
This trial is currently completed. It is a NA study. The enrollment target is 91 participants. The study started on 2021-01-11. Estimated completion is 2023-10-26.
What interventions are being tested in trial NCT04563130?
The interventions under investigation include: Cryocompression (BEHAVIORAL).
Who is sponsoring clinical trial NCT04563130?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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