← Back to Search

Lifestyle Interventions for Breast Cancer

N/A

Waitlist Available

Led By Lorenzo Cohen

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

Participants must be oriented to person, place, and time

Be older than 18 years old

Must not have

Patients with another primary cancer diagnosis within 5 years of consent, not including non-melanoma skin cancers

Patients with communication barriers (e.g., hard of hearing)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether an integrative oncology program can improve cancer-related outcomes in patients with stage II or III breast cancer undergoing radiation therapy.

Who is the study for?

This trial is for English-speaking women with stage II or III breast cancer who are about to start a 4-6 week course of radiotherapy. They should be oriented and have a BMI of at least 24.45. Participants must also have poor lifestyle habits, like eating less than three servings of fruits and vegetables per day, exercising minimally, and rarely engaging in mind-body practices.

What is being tested?

The study tests an integrative oncology program that includes diet changes, exercise, stress management, social support, and reducing environmental toxins during radiation therapy to see if it improves biological processes related to cancer and enhances patients' quality of life.

What are the potential side effects?

Since the interventions involve lifestyle modifications rather than medications, typical drug side effects aren't expected. However, participants may experience discomfort from increased physical activity or dietary changes.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am aware of who I am, where I am, and the current time.

Exclusion Criteria

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

Select...

I have not had another primary cancer diagnosis in the last 5 years, except for non-melanoma skin cancers.

Select...

I have difficulty hearing or communicating.

Select...

My breast cancer has come back after treatment.

Select...

I cannot move in and out of a chair without help.

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

Study Objectives

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

Primary study objectives

Changes in biological pathways

Changes in dietary patterns

Changes in fitness levels

+3 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: Arm I (IO interventions)Experimental Treatment8 Interventions

Patients undergo up to 7 different IO intervention sessions per week during their 6-week course of radiotherapy for between 1 and 3 hours each session, in addition to, up to 6 aerobic training sessions per week and one grocery store trip during the course of the program. IO intervention programs consist of nutritional coaching, behavioral therapy, yoga and meditation practice, resistance training, and a weekly meal sharing and cooking class. Patients then have weekly meetings with the study psychologist on the computer for 6 months, followed by a monthly meeting on the computer from 6-12 months, and 2 hour meetings at all follow-up appointments during the first year after radiotherapy.

Group II: Arm II (standard of care)Active Control4 Interventions

Patients undergo standard of care.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Exercise Intervention

2016

Completed Phase 4

~1330

0 / 5Eligibility criteria met