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Exercise-based Rehabilitation to Treat Persistent Chemotherapy Induced Peripheral Neuropathy (CIPN)

Chemotherapy-induced Peripheral Neuropathy

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

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Participation Requirements

  • Sex:

    ALL

  • Eligible Ages:

    18 and up

Participation 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)

Study Location

ELLICSR: Health Wellness and Cancer Survivorship Centre
ELLICSR: Health Wellness and Cancer Survivorship Centre
Toronto, Ontario
Canada

Contact Study Team

Primary Contact

Eric Antonen

[email protected]
416-581-8453
Study Sponsored By
University Health Network, Toronto
Participants Required
More Information
Study ID: NCT06405542