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NCT03873272 · ClinicalTrials.gov registry record · NA
The CONTRoL Trial: Cryotherapy vs. cOmpression Neuropathy TRiaL
A NA study, sponsored by Columbia University.
- Completed
- Registry status
- NA
- Development phase
- 63
- Enrollment target
NCT03873272: Completed NA study, sponsored by Columbia University.
NCT03873272 is a NA study that has completed, run by Columbia University. The registered enrollment target is 63 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03873272, a NA study, has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- NA
- Development phase
- 63 participants
- Enrollment target
Study Summary
The primary objective of this study is to select the best intervention from cold therapy, compression therapy and placebo at reducing neuropathic pain as measured by the change in the Neurotoxicity (NTX) component of the Functional Assessment of Cancer Therapy (FACT) - Taxane questionnaire, following 12 weeks of neoadjuvant/adjuvant chemotherapy with paclitaxel or docetaxel among breast cancer patients.
Primary Outcome
The primary endpoint is the change in FACT NTX at 12 weeks from the start of chemotherapy. The change in FACT NTX will be dichotomized into a good outcome (change in FACT NTX less than 5 from baseline to week 12) versus a poor outcome (change in FACT NTX greater than or equal to 5 from baseline to week 12). The FACT-NTX subscale includes 11 items, each of which is divided into 5 scoring levels: 0, 1, 2, 3, 4, and a total score of 44. The scale is graded 0-4. A low score indicates a good effect.
Interventions
- DEVICE Cryotherapy
- DEVICE Compression Therapy
- DEVICE Loose glove/sock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2019-04-25 |
| Est. Completion | 2023-02-02 |
| Phase | NA |
What the finished NCT03873272 record still lists
NCT03873272 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 63 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 3 interventions - of which Cryotherapy is the first listed.
NCT03873272 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03873272 about?
NCT03873272 is a clinical study titled "The CONTRoL Trial: Cryotherapy vs. cOmpression Neuropathy TRiaL". The primary objective of this study is to select the best intervention from cold therapy, compression therapy and placebo at reducing neuropathic pain as measured by the change in the Neurotoxicity (NTX) component of the Functional Assessment of Cancer Therapy (FACT) - Taxane questionnaire, followin...
What is the current status of trial NCT03873272?
This trial is currently completed. It is a NA study. The enrollment target is 63 participants. The study started on 2019-04-25. Estimated completion is 2023-02-02.
What interventions are being tested in trial NCT03873272?
The interventions under investigation include: Cryotherapy (DEVICE), Compression Therapy (DEVICE), Loose glove/sock (DEVICE).
Who is sponsoring clinical trial NCT03873272?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03873272's enrollment target sits among peer trials
63 1157th of 2000 higher than 844 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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