Exercise program to help cancer survivors with nerve pain from chemotherapy
EX-CIPN: An Exercise-based Rehabilitation Intervention to Treat Persistent Chemotherapy-Induced Peripheral Neuropathy (CIPN)
This study tests if a 10-week exercise program can help cancer survivors with nerve pain from chemotherapy feel better.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Health Network, Toronto Academic / other |
| Drugs / interventions | trastuzumab, chemotherapy |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT06405542 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the feasibility, acceptability, and safety of an exercise-based intervention called EX-CIPN for cancer survivors suffering from persistent chemotherapy-induced peripheral neuropathy (CIPN). Participants will engage in a 10-week remote, individualized exercise program, receive health coaching calls, and track their physical activity using a FitBit. Assessments will be conducted at baseline, immediately after the intervention, and three months post-intervention to measure the effectiveness of the program in alleviating CIPN symptoms.
Who should consider this trial
Good fit: Ideal candidates are cancer survivors who are more than six months post-chemotherapy and experience persistent symptoms of CIPN.
Not a fit: Patients currently undergoing chemotherapy or those with severe neuropathy symptoms may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the quality of life for cancer survivors by reducing the symptoms of chemotherapy-induced peripheral neuropathy.
How similar studies have performed: Other studies have shown promise in using exercise interventions for managing CIPN, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Received a diagnosis of any cancer and treated with curative intent (no minimum dose) including Stage 3 \& 4 gynecologic malignancies, treated in the platinum-sensitive setting * Are \> 6 months post-completion of chemotherapy (ie no other chemotherapeutic agents since completing of the chemotherapy regimen) * Report \> Grade 1 on the Patient Reported NCI Common Terminology Criteria for Adverse Events version 5.0 grading scale (numbness and tingling severity item) and neuropathic pain \>3 on the Neuropathic Pain 4 (DN4) (interview) (0-7) * The presence of peripheral neuropathy due to chemotherapy (following onset of chemotherapy), as established via clinical assessment * May be on maintenance oncologic therapies (ie endocrine therapy, Poly (ADP-ribose) polymerase (PARP) inhibitors) not known to cause neuropathy * No current plans for chemotherapy in the next 6 months * Currently engaging in \< 90min per week of planned moderate-intensity aerobic exercise * Independent with ambulation and transfers with or without ambulatory assistance (EGOG 0-2) * Able to communicate sufficiently in English to complete intervention, questionnaires, and consent * Willing to participate in the intervention and attend in-person physical assessments * Have access to and are able to operate videoconferencing. Exclusion Criteria: * Known neurological conditions influencing cognition and preventing safe or appropriate engagement with self-management and exercise recommendations * Pre-existing neuropathy prior to the start of chemotherapy * Are currently enrolled in other cancer rehabilitation or exercise-based programs/interventions. * Are currently taking ado-trastuzumab emtansine (TDM1) (ex. Kadcyla)
Where this trial is running
Toronto, Ontario
- ELLICSR: Health Wellness and Cancer Survivorship Centre — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: Eric Antonen
- Email: eric.antonen2@uhn.ca
- Phone: 416-581-8453
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.