Overview
The goal of this clinical trial is to learn if the EX-CIPN exercise-based intervention is feasible, acceptable, and safe in participants with persistent chemotherapy-induced peripheral neuropathy (CIPN). It will also give insight on the effectiveness of the exercise intervention in treating CIPN symptoms. The main questions it aims to answer are:
- Is EX-CIPN safe, acceptable, and feasible in cancer survivors experiencing persistent CIPN?
- Are the study design and methods feasible (recruitment and retention rates, feasibility of data collection and procedures)?
Researchers will provide all participants with the exercise-based intervention.
Participants will:
- Complete assessments at baseline, immediately post-intervention, and 3-months post-intervention
- Complete a 10-week remote, individualized exercise program
- Receive health coaching calls on weeks 2, 3, 4, 6, and 8 of the intervention
- Wear a FitBit throughout the study to track physical activity and promote behaviour change
Eligibility
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)