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

University Health Network, Toronto

Status and phase: Enrolling; Phase 1

Conditions: Chemotherapy-induced Peripheral Neuropathy

Treatments: Behavioral: EX-CIPN

Study type: Interventional

Funder types: Other

Identifiers

NCT06405542

23-5839

Details and patient eligibility

About

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

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

EX-CIPN Exercise- Based intervention

Experimental group

Description:

This arm is provided with an intervention that includes an individualized exercise program, remote monitoring, and remote person-to-person clinical support.

Treatment:

Behavioral: EX-CIPN