Effects of exercise on nerve damage from chemotherapy
Multi-Center Randomized Controlled Phase II Trial of Exercise to Treat Chemotherapy-Induced Peripheral Neuropathy (CIPN)
This study is testing if exercise can help people with cancer who have nerve damage from chemotherapy feel better compared to just getting standard care.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 132 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Rochester Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 93 sites (Fresno, California and 92 other locations) |
| Trial ID | NCT04888988 on ClinicalTrials.gov |
What this trial studies
This phase II trial investigates whether exercise can effectively treat chemotherapy-induced peripheral neuropathy (CIPN) compared to standard care. Participants with a cancer diagnosis who have experienced neurotoxic chemotherapy will be randomized into two groups: one receiving exercise interventions and the other receiving usual care. The study will assess the efficacy of exercise on CIPN symptoms through patient-reported outcomes and clinical tests. Additionally, it will explore the impact of exercise on related symptoms such as anxiety, depression, and quality of life.
Who should consider this trial
Good fit: Ideal candidates include adults diagnosed with cancer who have experienced neurotoxic chemotherapy and report significant CIPN symptoms.
Not a fit: Patients with physical limitations that prevent participation in exercise programs may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a non-pharmacological treatment option for patients suffering from CIPN.
How similar studies have performed: Other studies have shown promising results for exercise as a treatment for neuropathy, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Have a diagnosis of cancer * Have received neurotoxic chemotherapy within the past nine months (could still be on chemotherapy or have already completed chemotherapy; i.e., taxane-, platinum-, vinca alkaloid-, epothilone-, or proteasome inhibitor-based chemotherapy * Report one or more symptoms of CIPN at a level of \>= 4 on the CIPN symptom inventory on the Screening Form * Have an Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * Have at least six months life expectancy * Be at least 18 years of age * Be able to read and understand English * Be able to provide written informed consent Exclusion Criteria: * Have physical limitations (e.g., cardiorespiratory, orthopedic, central nervous system) that contraindicate participation in a low to moderate intensity home-based walking and progressive resistance exercise program, according to the participant's physician (e.g., oncologist, primary care) or physician's designee * Be identified as in the active or maintenance stage of exercise behavior per the Exercise Stages of Change Question on the Screening Form * Have planned surgery or radiation treatment during the course of the study (hormonal and biologic therapy is allowed) * Have contraindications for MRI scanning, per the MRI safety screening procedures of the MRI facility to be utilized for this participant * Are pregnant of have plans to become pregnant during the course of the study. Documentation of pregnancy and use of contraception can be obtained from the medical record. * Have a current or prior cancer in the central nervous system (spine, brainstem, brain) as this would interfere with assessments of brain functional connectivity.
Where this trial is running
Fresno, California and 92 other locations
- Kaiser Permanente-Fresno — Fresno, California, United States (Recruiting)
- Contra Costa Regional Medical Center — Martinez, California, United States (Recruiting)
- Kaiser Permanente-Roseville — Roseville, California, United States (Recruiting)
- Kaiser Permanente Downtown Commons — Sacramento, California, United States (Recruiting)
- Kaiser Permanente-South Sacramento — Sacramento, California, United States (Recruiting)
- Kaiser Permanente-Santa Teresa-San Jose — San Jose, California, United States (Recruiting)
- Kaiser Permanente San Leandro — San Leandro, California, United States (Recruiting)
- Kaiser San Rafael-Gallinas — San Rafael, California, United States (Recruiting)
- Kaiser Permanente Medical Center - Santa Clara — Santa Clara, California, United States (Recruiting)
- Kaiser Permanente-South San Francisco — South San Francisco, California, United States (Recruiting)
- Kaiser Permanente-Vallejo — Vallejo, California, United States (Recruiting)
- Kaiser Permanente-Walnut Creek — Walnut Creek, California, United States (Recruiting)
- Rocky Mountain Cancer Centers-Aurora — Aurora, Colorado, United States (Recruiting)
- Boulder Community Foothills Hospital — Boulder, Colorado, United States (Recruiting)
- Rocky Mountain Cancer Centers-Boulder — Boulder, Colorado, United States (Recruiting)
- Rocky Mountain Cancer Centers - Centennial — Centennial, Colorado, United States (Recruiting)
- The Women's Imaging Center — Denver, Colorado, United States (Recruiting)
- Colorado Blood Cancer Institute — Denver, Colorado, United States (Recruiting)
- Rocky Mountain Cancer Centers-Midtown — Denver, Colorado, United States (Recruiting)
- Rocky Mountain Cancer Centers-Rose — Denver, Colorado, United States (Recruiting)
- Rocky Mountain Cancer Centers - Swedish — Englewood, Colorado, United States (Recruiting)
- The Melanoma and Skin Cancer Institute — Englewood, Colorado, United States (Recruiting)
- Rocky Mountain Cancer Centers-Lakewood — Lakewood, Colorado, United States (Recruiting)
- Rocky Mountain Cancer Centers-Littleton — Littleton, Colorado, United States (Recruiting)
- Rocky Mountain Cancer Centers-Sky Ridge — Lone Tree, Colorado, United States (Recruiting)
- Rocky Mountain Cancer Centers-Longmont — Longmont, Colorado, United States (Recruiting)
- Rocky Mountain Cancer Centers-Thornton — Thornton, Colorado, United States (Recruiting)
- Beebe South Coastal Health Campus — Millville, Delaware, United States (Recruiting)
- Helen F Graham Cancer Center — Newark, Delaware, United States (Recruiting)
- Medical Oncology Hematology Consultants PA — Newark, Delaware, United States (Recruiting)
- Beebe Health Campus — Rehoboth Beach, Delaware, United States (Recruiting)
- MedStar Georgetown University Hospital — Washington, District of Columbia, United States (Recruiting)
- MedStar Washington Hospital Center — Washington, District of Columbia, United States (Recruiting)
- Hawaii Cancer Care - Westridge — Aiea, Hawaii, United States (Recruiting)
- Pali Momi Medical Center — Aiea, Hawaii, United States (Recruiting)
- Hawaii Cancer Care Inc - Waterfront Plaza — Honolulu, Hawaii, United States (Recruiting)
- Straub Clinic and Hospital — Honolulu, Hawaii, United States (Recruiting)
- University of Hawaii Cancer Center — Honolulu, Hawaii, United States (Recruiting)
- Kapiolani Medical Center for Women and Children — Honolulu, Hawaii, United States (Recruiting)
- SIH Cancer Institute — Carterville, Illinois, United States (Recruiting)
- Centralia Oncology Clinic — Centralia, Illinois, United States (Recruiting)
- Carle at The Riverfront — Danville, Illinois, United States (Recruiting)
- Cancer Care Specialists of Illinois - Decatur — Decatur, Illinois, United States (Recruiting)
- Decatur Memorial Hospital — Decatur, Illinois, United States (Recruiting)
- Crossroads Cancer Center — Effingham, Illinois, United States (Recruiting)
- Cancer Care Center of O'Fallon — O'Fallon, Illinois, United States (Recruiting)
- Carle Cancer Center — Urbana, Illinois, United States (Recruiting)
- Physicians' Clinic of Iowa PC — Cedar Rapids, Iowa, United States (Recruiting)
- Oncology Associates at Mercy Medical Center — Cedar Rapids, Iowa, United States (Recruiting)
- Mercy Medical Center - Des Moines — Des Moines, Iowa, United States (Recruiting)
+43 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Principal investigator: Ian R Kleckner — University of Rochester NCORP Research Base
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.