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Exercise Program for Breast Cancer Fatigue

N/A

Recruiting

Led By Priya P Gor, MD, MSCE

Research Sponsored by Virtua Health, Inc.

Eligibility Criteria Checklist

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

Must have

ECOG performance score < 3

Age > 18 years

Must not have

Coronary artery disease, not cleared by cardiologist

Chronic fatigue syndrome

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 6 following completion of chemotherapy

Awards & highlights

No Placebo-Only Group

Summary

This trial tests how home exercise can reduce fatigue in people with breast cancer receiving chemotherapy. Subjects use a mobile device to report outcomes weekly.

Who is the study for?

This trial is for English-speaking women over 18 with breast cancer, planning to undergo at least 4 chemotherapy cycles. They must be able to exercise (if cleared by a cardiologist), have an ECOG score <3, and own a device like a smartphone for reporting. It's not for those with exercise contraindications or certain medical/psychiatric conditions.

What is being tested?

The study tests if home exercises can reduce fatigue in breast cancer patients during chemotherapy. Participants are randomly assigned to either control (no exercise) or intervention (exercise) groups, and they report their fatigue levels using specific tools online throughout the treatment period.

What are the potential side effects?

Since this trial involves an exercise program rather than medication, side effects may include typical physical responses to exercise such as muscle soreness or strain especially when starting new routines or increasing intensity.

Eligibility Criteria

Inclusion Criteria

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

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I can take care of myself but may not be able to do heavy physical work.

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I am older than 18 years.

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I am a woman planning to undergo at least 4 chemotherapy cycles for breast cancer.

Exclusion Criteria

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

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I have heart artery disease not approved by a heart doctor.

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I have been diagnosed with chronic fatigue syndrome.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 6 following completion of chemotherapy

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~month 6 following completion of chemotherapy

This trial's timeline: 3 weeks for screening, Varies for treatment, and month 6 following completion of chemotherapy for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Determine the feasibility of a specific home-based exercise program in reducing cancer-related fatigue.

Secondary study objectives

To quantify the change over time in PRO-CTCAE derived symptoms

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

Intervention: Subject will be assessed by a Physical Therapist. Based on the assessment, the Physical Therapist will provide the patient with a home-based exercise program including core exercises as follows: Core Stabilization, core extension, leg extensions, squats with and without weights, shoulder and arm exercises. Patients will be asked to complete a symptom survey weekly via a web-based platform for tracking cancer and treatment-related symptoms and fatigue.

Group II: ControlActive Control1 Intervention

Subject will not be provided an exercise program but will be asked to complete the symptom survey weekly via a web-based platform for tracking cancer and treatment-related symptoms and fatigue.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Exercise

2016

Completed Phase 1

~820

0 / 5Eligibility criteria met