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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: Completed NA study, sponsored by Duke University.
NCT04563130 is a NA study that has completed, run by Duke University. The registered enrollment target is 91 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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)
Interventions
- BEHAVIORAL Cryocompression
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 91 participants |
| Start Date | 2021-01-11 |
| Est. Completion | 2023-10-26 |
| Phase | NA |
What the finished NCT04563130 record still lists
NCT04563130 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 91 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 1 intervention - of which Cryocompression is the first listed.
NCT04563130 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04563130's enrollment target sits among peer trials
91 939th of 2000 higher than 1,060 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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