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Exercise Regimen for Breast Cancer

N/A

Waitlist Available

Led By Karen Milligan, MD

Research Sponsored by Nevada Cancer Institute

Eligibility Criteria Checklist

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

Must have

Requires treatment that includes chemotherapy, radiation therapy or both chemotherapy and radiation therapy

Stage 0 to III breast cancer prior to any treatment and at time of diagnosis

Must not have

Major surgery within last 6 months that requires exercise restriction

Metastatic breast cancer (Stage IV)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare the outcomes of two groups, one of which will receive a physical activity intervention while the other will only receive limited information on activity.

Who is the study for?

This trial is for women over 18 with Stage 0 to III breast cancer, diagnosed before treatment. Participants must need chemo or radiation therapy and be fit enough for exercise as determined by the study team. They can't join if they have advanced cancer, started treatment already, don't need chemo or radiation, are pregnant/lactating, have certain chronic diseases or recent major surgery.

What is being tested?

The study tests an exercise program starting at diagnosis and continuing through treatment into six months of survivorship against a control group that receives basic activity information. The goal is to compare physical outcomes between those who follow the regimen and those who do not.

What are the potential side effects?

While specific side effects aren't listed for exercising during cancer treatment in this summary, common concerns may include fatigue, muscle soreness, joint pain or increased risk of injury. Any unusual symptoms should be reported to the research team.

Eligibility Criteria

Inclusion Criteria

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

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I need treatment that involves chemotherapy, radiation, or both.

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My breast cancer is between stage 0 and III and I haven't started treatment.

Exclusion Criteria

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

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I had major surgery less than 6 months ago that limits my physical activity.

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My breast cancer has spread to other parts of my body.

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I have diabetes.

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My breast cancer treatment does not include chemotherapy or radiation.

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I have a known heart condition.

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My high blood pressure is not under control.

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I currently have an infection.

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I have lost 10% or more of my body weight in the last 6 months.

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My thyroid condition is not under control.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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: Intervention GroupExperimental Treatment1 Intervention

Each patient will have a weekly goal of 2000 calories burned and 18 MET-hours of exercise which can be achieved in 4 to 7 hours of physical activity per week. Resistance training, using weight machines and aerobic training using treadmills, elliptical trainers and stationary bicycles, will be utilized in the intervention group.

Group II: Control GroupActive Control1 Intervention

The control group will receive basic information on physical activity but not be instructed.

0 / 11Eligibility criteria met