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NCT05642611 · ClinicalTrials.gov registry record · Phase 3
Comparing Cooling and/or Compression Approaches of Limbs for Prevention of Chemotherapy-Induced Peripheral Neuropathy
A Phase 3 study of Malignant Solid Neoplasm, sponsored by SWOG Cancer Research Network.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 777
- Enrollment target
- 20
- Study locations
NCT05642611: Recruiting Phase 3 study of Malignant Solid Neoplasm, sponsored by SWOG Cancer Research Network.
NCT05642611 is a Phase 3 study of Malignant Solid Neoplasm that is actively recruiting participants, run by SWOG Cancer Research Network. The registered enrollment target is 777 participants, below the 1,136-participant average among 176 other Malignant Solid Neoplasm trials with a reported enrollment target (32% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05642611, a Phase 3 study of Malignant Solid Neoplasm, is actively recruiting participants, sponsored by SWOG Cancer Research Network.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 777 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase III trial compares the effect of 3 study approaches in preventing chemotherapy-induced peripheral neuropathy: 1) cryocompression, 2) continuous compression, and 3) low cyclic compression. Taxane chemotherapy drugs, such as paclitaxel or docetaxel, can cause a nerve disorder called peripheral neuropathy, which can cause numbness, tingling, or pain in the arms and legs. The 3 study approaches will use a device, called the Paxman Limb Cryocompression System, made of wraps that cool and/or compress the arms and legs. This study may help researchers determine if any of the study approaches are able to prevent taxane chemotherapy from causing peripheral neuropathy.
Primary Outcome
Defined as an absolute increase of 8 or more points over baseline in the CIPN-20 sensory neuropathy subscale score. Analysis will be conducted multivariable logistic regression, adjusting for the baseline score and the stratification factor as covariates.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- OTHER Quality-of-Life Assessment
- PROCEDURE Cryocompression Therapy
- PROCEDURE Pneumatic Compression Therapy
Study Locations (20)
Kansas
- University of Kansas Cancer Center - Kansas City
- University of Kansas Hospital-Indian Creek Campus - Overland Park
- University of Kansas Hospital-Westwood Cancer Center - Westwood
Michigan
- Henry Ford Macomb Hospital-Clinton Township - Clinton Township
- Henry Ford Hospital - Detroit
- Corewell Health Grand Rapids Hospitals - Butterworth Hospital - Grand Rapids
North Carolina
- CaroMont Regional Medical Center - Gastonia
- Cone Health Cancer Center - Greensboro
- Margaret R Pardee Memorial Hospital - Hendersonville
New Jersey
- The Valley Hospital - Luckow Pavilion - Paramus
- Valley Health System Ridgewood Campus - Ridgewood
New York
- NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center - New York
- State University of New York Upstate Medical University - Syracuse
Alabama
- University of Alabama at Birmingham Cancer Center - Birmingham
California
- Contra Costa Regional Medical Center - Martinez
Georgia
- Emory University Hospital/Winship Cancer Institute - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 777 participants |
| Start Date | 2023-06-06 |
| Est. Completion | 2031-08-30 |
| Phase | Phase 3 |
What NCT05642611 shows while recruiting
NCT05642611 is an interventional study that assigns participants to a tested intervention. The registered 777 participants enrollment target is mid-sized for trials with a published cap, below the 1,136-participant average among 176 other Malignant Solid Neoplasm trials with a reported enrollment target (32% lower).
The record links to 1 condition, with Malignant Solid Neoplasm appearing as the primary indexed condition, and to 4 interventions - of which Biospecimen Collection is the first listed.
NCT05642611 names 20 study sites across 12 states, led by Kansas, Michigan, North Carolina.
Frequently Asked Questions
What is clinical trial NCT05642611 about?
NCT05642611 is a clinical study titled "Comparing Cooling and/or Compression Approaches of Limbs for Prevention of Chemotherapy-Induced Peripheral Neuropathy". This phase III trial compares the effect of 3 study approaches in preventing chemotherapy-induced peripheral neuropathy: 1) cryocompression, 2) continuous compression, and 3) low cyclic compression. Taxane chemotherapy drugs, such as paclitaxel or docetaxel, can cause a nerve disorder called periphe...
What is the current status of trial NCT05642611?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 777 participants. The study started on 2023-06-06. Estimated completion is 2031-08-30.
What conditions does trial NCT05642611 study?
This clinical trial studies the following conditions: Malignant Solid Neoplasm.
What interventions are being tested in trial NCT05642611?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Quality-of-Life Assessment (OTHER), Cryocompression Therapy (PROCEDURE), Pneumatic Compression Therapy (PROCEDURE).
Who is sponsoring clinical trial NCT05642611?
This trial is sponsored by SWOG Cancer Research Network, which has 270 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05642611 being conducted?
This trial has 20 study locations across Alabama, California, Georgia, Hawaii, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Malignant Solid Neoplasm
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05642611's enrollment target sits among peer trials
777 21st of 176 higher than 156 of 176 other Malignant Solid Neoplasm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Malignant Solid Neoplasm 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.
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