Exercise and nutrition interventions for chemotherapy-induced nerve damage
The Effects of Exercise and Nutrition Interventions on Platinum Chemotherapy-induced Peripheral Neuropathy and Interoceptive Brain Circuitry (R21)
This study is testing whether exercise or nutrition education can help cancer patients with nerve damage caused by chemotherapy feel better.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Maryland, Baltimore Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT05452902 on ClinicalTrials.gov |
What this trial studies
This phase II randomized controlled trial aims to evaluate the effectiveness of exercise compared to nutrition education in managing chemotherapy-induced peripheral neuropathy (CIPN) in cancer patients receiving platinum-based chemotherapy. The study will explore the roles of inflammation and interoception in CIPN and gather data to inform future research. Participants will be enrolled before their first, second, or third infusion of neurotoxic chemotherapy and will be monitored for changes in their symptoms and overall well-being.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are scheduled to receive platinum chemotherapy and do not engage in regular exercise.
Not a fit: Patients who are already performing regular exercise or have physical limitations that prevent them from participating may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide new non-pharmacological strategies to alleviate the debilitating symptoms of chemotherapy-induced peripheral neuropathy.
How similar studies have performed: Other studies have shown promise in using exercise and lifestyle interventions for managing chemotherapy-related side effects, but this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria (subjects must...) 1. Have a diagnosis of cancer 2. Be scheduled to receive platinum chemotherapy (specifically oxaliplatin or cisplatin) without other neurotoxic chemotherapy (taxanes, bortezomib, thalidomide). Patients may be enrolled before their first (preferred), second, or third infusion of neurotoxic chemotherapy 3. Be able to read English 4. Be ≥18 years Exclusion criteria (subjects must not...) 1. Be performing regular exercise, which is any planned physical activity (e.g., brisk walking, aerobics, jogging, bicycling, swimming, rowing, weight lifting, resistance training, yoga, pilates, etc.) performed to increase physical fitness. To be considered exercise, physical activity should be performed 3-5 times per week for 20-60 minutes per session and should be done at a level that increases your breathing rate and causes you to break a sweat. 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. 3. Have planned surgery or radiation treatment in the 12 weeks after baseline. Additional exclusion criteria only for patients completing MRI (approximately 40 of 60 enrolled subjects; subjects must not...) 1. Have current or prior cancer in the spine, brainstem, or brain (to allow standard brain MRI analysis) 2. Have contraindications for MRI scanning (pacemaker, ferrous metal implants, pregnancy, etc. note that most port-a-caths are safe for MRI scanning)
Where this trial is running
Baltimore, Maryland
- University of Maryland Medical System — Baltimore, Maryland, United States (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.