Cycling-Based Aerobic Exercise Intervention for Individuals With Chemotherapy-Induced Peripheral Neuropathy (CIPN)

NCT07150117 | Recruiting

• 1 other identifier: HREBA.CC-25-0188
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

CYCLE-CIPN is a proof-of-concept study designed to evaluate whether a prescribed aerobic exercise intervention has the potential to reduce the symptoms and functional impact of CIPN. The small number of participants in the proposed study will allow us to make decisions on the feasibility ("go/no-go") of a future larger-scale trial. The protocol will assess feasibility and acceptability through recruitment, completion, adherence, program satisfaction, and safety. The study will also evaluate CIPN symptoms using both patient-reported and objective outcome measures, as well as fitness and quality of life outcomes. We aim to recruit 30 participants. The Health Research Board of Alberta Cancer Committee has approved this study. Participants will participate in a stationary cycling-based aerobic exercise program biweekly for 12 weeks. Exercise sessions will be supervised and progressive, between 30 and 60 minutes each.

Conditions

Cancer; Adults

Keywords

peripheral neuropathy; chemotherapy; exercise; aerobic; cancer

Outcome Measures

Primary Outcomes (1)

• Recruitment

  Recruitment rate of 30 participants in one year

  One year

Secondary Outcomes (3)

• Study completion

  One year

• Adherence

  12 weeks

• Program satisfaction

  12 weeks

Study Arms (1)

Aerobic exercise intervention

EXPERIMENTAL

Cycling-based aerobic exercise

Behavioral: Exercise

Interventions

Exercise BEHAVIORAL

A supervised 12-week cycling-based aerobic exercise intervention performed twice per week.

Aerobic exercise intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• Cancer diagnosis stage I to III
• CIPN: grade 1 (mild)
• Receiving or have received chemotherapy treatment for cancer
• Speak, read and understand English

You may not qualify if:

• Medical conditions that cause additional neuropathy symptoms (i.e. diabetes)
• Any uncontrolled medical conditions
• Will undergo surgery or radiation therapy during the study period
• Are already receiving an aerobic exercise training program
• Are already participating in an exercise-based research study
• Are unable to provide signed informed consent

Sponsors & Collaborators

• University of Alberta: lead
• Cross Cancer Institute: collaborator

Study Sites (1)

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

RECRUITING

MeSH Terms

Conditions

Neoplasms; Peripheral Nervous System Diseases; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Margaret L McNeely, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christopher Sellar, PhD

CONTACT

1-780-492-6007; frmace@ualberta.ca

Trei Lindstrom, BSc

CONTACT

1-780-492-6007; frmace@ualberta.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: An independent assessor will be used to collect post-intervention outcomes.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Proof of concept study

Study Record Dates

• First Submitted: August 24, 2025
• First Posted: September 2, 2025
• Study Start: January 26, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Data will be made available no later than 12 months following primary publication of study findings.
• Access Criteria: Data will be shared on request with qualified researchers affiliated with academic institutions, healthcare organizations, or other not-for-profit entities conducting methodologically sound research.

Locations

CA (1)