Clinical trial · Interventional
Exercise-based Rehabilitation to Treat Persistent Chemotherapy Induced Peripheral Neuropathy (CIPN)
EX-CIPN: An Exercise-based Rehabilitation Intervention to Treat Persistent Chemotherapy-Induced Peripheral Neuropathy (CIPN)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapy-induced Peripheral Neuropathy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EX-CIPN | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- EX-CIPN Exercise- Based intervention
- description
- This arm is provided with an intervention that includes an individualized exercise program, remote monitoring, and remote person-to-person clinical support.
- interventionNames
- Behavioral: EX-CIPN
Primary outcomes (4)
- measure
- Accrual Rate
- timeFrame
- Throughout study completion, up to 24 weeks.
- description
- Assessed based on CONSORT criteria through a screening log that tracks data collected of all screened patients. Eligibility screening will be performed to identify eligible consented and eligible non-recruited individuals with non-recruitment reasons documented. Number of participants consented and enrolled will be tracked each month.
- measure
- Retention Rates
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available