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Exercise + Nutrition Education for Peripheral Neuropathy

Phase 2

Recruiting

Research Sponsored by University of Rochester

Eligibility Criteria Checklist

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

Must have

Be scheduled to receive taxane chemotherapy without other neurotoxic chemotherapy (platinums, vinca alkaloids, bortezomib, thalidomide)

Be female

Must not have

Have physical limitations (e.g., cardiorespiratory, orthopedic, central nervous system) that contraindicate participation in maximal physiological fitness testing and a low/moderate intensity home-based walking and progressive resistance exercise program.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks) or time point 4 (approx. 24 weeks), controlling for baseline

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether exercise or nutrition education can help relieve side-effects from chemotherapy-induced peripheral neuropathy, which causes severe pain and numbness.

Who is the study for?

This trial is for women with breast cancer who are about to start taxane chemotherapy. They must be able to read English, be at least 18 years old, and have a life expectancy of at least six months. Participants should not already be active in exercise routines and must not have physical limitations that prevent them from exercising or MRI scans if applicable.

What is being tested?

The study compares the effects of an exercise program (EXCAP Exercise) versus nutrition education on chemotherapy-induced peripheral neuropathy (CIPN). It aims to understand how these interventions might influence inflammation and body awareness, helping design future studies.

What are the potential side effects?

Since this trial involves exercise and educational interventions rather than drugs, side effects may include typical exercise-related discomforts such as muscle soreness or fatigue. There are no drug-related side effects involved.

Eligibility Criteria

Inclusion Criteria

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

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I am scheduled for taxane chemotherapy without other nerve-damaging treatments.

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I am female.

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I have breast cancer.

Exclusion Criteria

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

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I have health issues that prevent me from doing intense exercise or walking programs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks) or time point 4 (approx. 24 weeks), controlling for baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks) or time point 4 (approx. 24 weeks), controlling for baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks) or time point 4 (approx. 24 weeks), controlling for baseline for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Patient-reported sensory symptoms of chemotherapy-induced peripheral neuropathy (CIPN)

Secondary study objectives

Numbness and tingling

Patient-reported sensory symptoms of CIPN

Sensory loss

+1 more

Other study objectives

Cardiovascular function

Immunological function

Musculoskeletal function

+1 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: ExerciseExperimental Treatment1 Intervention

Exercise for Cancer Patients (EXCAP©®) involves face-to-face instruction and a prescription for an at-home progressive walking and resistance exercise program.

Group II: Nutrition EducationActive Control1 Intervention

Nutrition education involves equal time and attention as the exercise arm, but the content covers nutrition for cancer patients and lacks an exercise prescription.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

EXCAP Exercise

2017

N/A

~30

0 / 4Eligibility criteria met