Exercise and nutrition interventions for chemotherapy-induced neuropathy
The Effects of Exercise and Nutrition Interventions on Chemotherapy-induced Peripheral Neuropathy and Interoceptive Brain Circuitry
This study tests if exercise and nutrition education can help women with breast cancer who are experiencing nerve pain from chemotherapy feel better.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Rochester Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Baltimore, Maryland and 1 other locations) |
| Trial ID | NCT03858153 on ClinicalTrials.gov |
What this trial studies
This phase II randomized controlled trial investigates the effects of exercise and nutrition education on chemotherapy-induced peripheral neuropathy (CIPN) in women undergoing taxane chemotherapy for breast cancer. The study aims to evaluate the preliminary efficacy of these interventions while exploring the roles of inflammation and interoception. Participants will be randomly assigned to either an exercise program or nutrition education to assess their impact on CIPN symptoms. The trial seeks to gather data that will inform future studies with a more accurate effect size.
Who should consider this trial
Good fit: Ideal candidates for this study are sedentary women diagnosed with breast cancer who are scheduled to receive taxane chemotherapy.
Not a fit: Patients who are already active in exercise or have physical limitations that prevent participation in the study will not benefit from this trial.
Why it matters
Potential benefit: If successful, this study could provide effective non-pharmacological interventions to alleviate CIPN symptoms in breast cancer patients undergoing chemotherapy.
How similar studies have performed: Other studies have shown promise in using exercise and nutrition interventions for managing chemotherapy side effects, but this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria (subjects must...) 1. Be female 2. Have breast cancer 3. Be scheduled to receive taxane chemotherapy without other neurotoxic chemotherapy (platinums, vinca alkaloids, bortezomib, thalidomide) 4. Have at least six months life expectancy according to the patient's oncologist or designee 5. Be able to read English 6. Be at least 18 years old (no upper limit on age) 7. Provide written informed consent Exclusion criteria (subjects must not...) 1. Be in the active or maintenance stage of exercise behavior (i.e., subjects must be sedentary) 2. Have physical limitations (e.g., cardiorespiratory, orthopedic, central nervous system) that contraindicate participation in maximal physiological fitness testing and a low/moderate intensity home-based walking and progressive resistance exercise program. Additional exclusion criteria only for patients performing the MRI scanning (40 of 80 enrolled subjects) 1. Subjects must not have contraindications for MRI scanning (pacemaker, metal implants, pregnancy, chest expander from breast reconstruction, etc.-note that most port-a-caths are safe for MRI scanning)
Where this trial is running
Baltimore, Maryland and 1 other locations
- University of Maryland — Baltimore, Maryland, United States (Recruiting)
- University of Rochester Medical Center — Rochester, New York, United States (Active_not_recruiting)
Study contacts
- Study coordinator: Ian Kleckner, PhD, MPH
- Email: ian.kleckner@umaryland.edu
- Phone: 410-706-5981
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.