Health TrialsbyHealthPanel

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

ConditionsCancerAdults
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Alberta

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18 years or older

Cancer diagnosis stage I to III

CIPN: grade 1 (mild)

Receiving or have received chemotherapy treatment for cancer

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Exercise

    Behavioral

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

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Aerobic exercise interventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Recruitment

Recruitment rate of 30 participants in one year

Time frame
One year

Secondary outcomes

1

Study completion

Completion rate: \>70% of participants consenting to the study complete the 12-week assessment

Time frame
One year
2

Adherence

Adherence rate \>70% for the prescription variables

Time frame
12 weeks
3

Program satisfaction

\>70% of participants reporting high to very high program satisfaction with higher scores indicating higher satisfaction with the intervention, program delivery and perceived benefits.

Time frame
12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Alberta

Lead sponsor

Cross Cancer Institute

Collaborator

Source ClinicalTrials.gov
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