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NCT03858153 · ClinicalTrials.gov registry record · Phase 2
Exercise and Nutrition Interventions During Chemotherapy K07
A Phase 2 study of Neuropathy;Peripheral, sponsored by University of Rochester.
- Completed
- Registry status
- Phase 2
- Development phase
- 80
- Enrollment target
- 2
- Study locations
NCT03858153: Completed Phase 2 study of Neuropathy;Peripheral, sponsored by University of Rochester.
NCT03858153 is a Phase 2 study of Neuropathy;Peripheral that has completed, run by University of Rochester. The registered enrollment target is 80 participants, above the 31-participant average among 6 other Neuropathy;Peripheral trials with a reported enrollment target (158% higher). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03858153, a Phase 2 study of Neuropathy;Peripheral, has completed, sponsored by University of Rochester.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 80 participants
- Enrollment target
- 2
- Study locations
Study Summary
Chemotherapy-induced peripheral neuropathy (CIPN) is a highly prevalent and severe side-effect of taxane chemotherapy, often used to treat breast cancer. Unfortunately there are very limited treatments for CIPN. This is a phase II randomized controlled trial to test the preliminary efficacy of exercise vs. nutrition education on CIPN, to systematically investigate the potential roles of inflammation and interoception, and to obtain data with a more accurate effect size to inform a future study.
Primary Outcome
CIPN-20 sensory subscale (Postma et al 2005). The subscale includes 9 questions, each rated 1-4, and the score ranges from 9-36 with larger values reflecting more severe (worse) symptoms of chemotherapy-induced peripheral neuropathy (CIPN).
Conditions Studied
Interventions
- BEHAVIORAL Nutrition Education
- BEHAVIORAL EXCAP Exercise
Study Locations (2)
Maryland
- University of Maryland - Baltimore
New York
- University of Rochester Medical Center - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2019-04-15 |
| Est. Completion | 2025-08-27 |
| Phase | Phase 2 |
What the finished NCT03858153 record still lists
NCT03858153 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, above the 31-participant average among 6 other Neuropathy;Peripheral trials with a reported enrollment target (158% higher).
The record links to 1 condition, with Neuropathy;Peripheral appearing as the primary indexed condition, and to 2 interventions - of which Nutrition Education is the first listed.
NCT03858153 reports a single indexed study location in Maryland, New York.
Frequently Asked Questions
What is clinical trial NCT03858153 about?
NCT03858153 is a clinical study titled "Exercise and Nutrition Interventions During Chemotherapy K07". Chemotherapy-induced peripheral neuropathy (CIPN) is a highly prevalent and severe side-effect of taxane chemotherapy, often used to treat breast cancer. Unfortunately there are very limited treatments for CIPN. This is a phase II randomized controlled trial to test the preliminary efficacy of exerc...
What is the current status of trial NCT03858153?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 80 participants. The study started on 2019-04-15. Estimated completion is 2025-08-27.
What conditions does trial NCT03858153 study?
This clinical trial studies the following conditions: Neuropathy;Peripheral.
What interventions are being tested in trial NCT03858153?
The interventions under investigation include: Nutrition Education (BEHAVIORAL), EXCAP Exercise (BEHAVIORAL).
Who is sponsoring clinical trial NCT03858153?
This trial is sponsored by University of Rochester, which has 636 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03858153 being conducted?
This trial has 2 study locations across Maryland, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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