The Role of Lifestyle Factors in Breast Cancer-Related Outcomes

Running, not enrolling · Not applicable

Conditions studied: Stage II Breast Cancer AJCC v6 and v7, Stage IIA Breast Cancer AJCC v6 and v7, Stage IIB Breast Cancer AJCC v6 and v7, Stage III Breast Cancer AJCC v7, Stage IIIA Breast Cancer AJCC v7, Stage IIIB Breast Cancer AJCC v7, Stage IIIC Breast Cancer AJCC v7

In brief

This randomized clinical trial studies an integrative oncology (making changes in lifestyle and behavior) program in improving cancer-related outcomes in patients with stage II or III breast cancer undergoing radiation therapy. An integrative oncology program consisting of dietary recommendations, physical activity, stress management, social support, and control of environmental contaminants may modify cancer-related biological processes, influence long-term treatment results, and improve the quality of life of patients.

Key facts

Study ID

NCT02079662

Run by

M.D. Anderson Cancer Center

People needed

110

Starts

2013-06-13

Expected to finish

2030-12-31

Last updated by the study team

2026-06-11

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Women with stage II or III breast cancer that will be scheduled to undergo a 4 to 6-week course of radiotherapy
• Participants must be able to read, write, and speak English
• Participants must be oriented to person, place, and time
• Participants must also meet at least two of the following criteria related to lifestyle: 1) consume less than 3 servings of fruit and vegetable/day; 2) engage in less than 75 minutes moderate/vigorous activity per week, defined as anything that causes small increases in breathing or heart rate for a sustained amount of time (e.g., brisk walking, bicycling); and 3) engage in a mind-body practice less than 4 times a month
• Participants must have a body mass index (BMI) of 24.45 or higher as assessed in the medical record

You may not qualify if…

• Patients with a recurrent breast cancer diagnosis
• Patients with another primary cancer diagnosis within 5 years of consent, not including non-melanoma skin cancers
• Patients who have any major psychiatric diagnoses or thought disorder (e.g. schizophrenia, bi-polar disorder, dementia)
• Patients with communication barriers (e.g., hard of hearing)
• Patients with extreme mobility issues (e.g. unable to get in and out of a chair unassisted)
• Patients with poorly or uncontrolled diabetes in the opinion of the physician(s)

Where it is running

• M D Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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