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Behavioral Intervention

Exercise Rehabilitation for Peripheral Neuropathy (EX-CIPN Trial)

Phase 1

Recruiting

Research Sponsored by University Health Network, Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

The presence of peripheral neuropathy due to chemotherapy as established via clinical assessment

Independent with ambulation and transfers with or without ambulatory assistance (EGOG 0-2)

Must not have

Currently taking ado-trastuzumab emtansine (TDM1) (ex. Kadcyla)

Pre-existing neuropathy prior to the start of chemotherapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, post-intervention (10 weeks), 3-months post-intervention (20-24 weeks)

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to determine if a specific exercise program called EX-CIPN is safe and effective in helping cancer survivors with persistent chemotherapy-induced peripheral neuropathy (CIPN). Participants will undergo assessments and

Who is the study for?

This trial is for cancer survivors who are dealing with persistent chemotherapy-induced peripheral neuropathy (CIPN). Participants should be willing to engage in a 10-week exercise program, receive health coaching calls, and wear a FitBit. Specific eligibility criteria were not provided.

What is being tested?

The EX-CIPN intervention being tested involves an individualized exercise program designed to treat symptoms of CIPN. The study will assess the safety, acceptability, and feasibility of this approach through participant assessments at various stages.

What are the potential side effects?

Since the intervention is exercise-based, typical side effects may include muscle soreness or strain. However, as it's tailored for individuals with CIPN, any adverse effects related to exacerbating their condition will be closely monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have nerve damage from chemotherapy.

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I can walk and move around on my own, with or without help.

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I was treated for cancer, including advanced gynecologic cancer, with the goal of curing it.

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I experience significant numbness, tingling, or neuropathic pain.

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I am not planning to undergo chemotherapy within the next 6 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently on Kadcyla (TDM1) treatment.

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I had nerve damage before starting chemotherapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, post-intervention (10 weeks), 3-months post-intervention (20-24 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, post-intervention (10 weeks), 3-months post-intervention (20-24 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, post-intervention (10 weeks), 3-months post-intervention (20-24 weeks) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Accrual Rate

Adherence

Intervention Safety

+1 more

Secondary study objectives

Aerobic Functional Capacity

Balance

CIPN Symptoms

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: EX-CIPN Exercise- Based interventionExperimental Treatment1 Intervention

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

0 / 7Eligibility criteria met