Clinical trial NCT06405542: Exercise-based Rehabilitation to Treat Persistent Chemotherapy Induced Peripheral Neuropathy (CIPN)
Official title: EX-CIPN: An Exercise-based Rehabilitation Intervention to Treat Persistent Chemotherapy-Induced Peripheral Neuropathy (CIPN)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Chemotherapy-induced Peripheral Neuropathy
Keywords: Cancer Rehabilitation
Peripheral Neuropathy
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2024-05-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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 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)

Primary outcomes:
measure: Accrual Rate
timeFrame: Throughout study completion, up to 24 weeks.
measure: Retention Rates
timeFrame: Baseline, post-intervention (10 weeks), 3-months post-intervention (20-24 weeks)
measure: Adherence
timeFrame: Through study completion, up to 24 weeks.
measure: Intervention Safety
timeFrame: Through study completion, up to 24 weeks.
Secondary outcomes:
measure: Pain Intensity
timeFrame: Baseline, post-intervention (10 weeks), 3-months post-intervention (20-24 weeks)
measure: CIPN Symptoms
timeFrame: Baseline, post-intervention (10 weeks), 3-months post-intervention (20-24 weeks)
measure: CIPN-related Disability
timeFrame: Baseline, post-intervention (10 weeks), 3-months post-intervention (20-24 weeks)
measure: Strength (Upper Body)
timeFrame: Baseline, post-intervention (10 weeks), 3-months post-intervention (20-24 weeks)
measure: Strength (Lower Body)
timeFrame: Baseline, post-intervention (10 weeks), 3-months post-intervention (20-24 weeks)
measure: Balance
timeFrame: Baseline, post-intervention (10 weeks), 3-months post-intervention (20-24 weeks)
measure: Gait Speed
timeFrame: Baseline, post-intervention (10 weeks), 3-months post-intervention (20-24 weeks)
measure: Aerobic Functional Capacity
timeFrame: Baseline, post-intervention (10 weeks), 3-months post-intervention (20-24 weeks)
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: ELLICSR: Health Wellness and Cancer Survivorship Centre
state: Ontario
Study officials:
References: