Lifestyle makeover may boost breast cancer outcomes during radiation
NCT ID NCT02079662
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether an integrative oncology program—including diet changes, exercise, stress management, social support, and reducing exposure to environmental toxins—can improve outcomes for women with stage II or III breast cancer undergoing radiation therapy. About 110 participants will be randomly assigned to either the program or standard care. Researchers will track disease-free survival, quality of life, and biological changes to see if the program makes a difference.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Integrative oncology program (dietary recommendations, physical activity, stress management, social support, environmental contaminant control)
- What this could lead to
- If it works, this program could help breast cancer patients live longer without the cancer returning and improve their quality of life during and after radiation therapy.
- What could go wrong
- This is a small, early-stage study with only 110 participants, so results may not apply to everyone. The program is complex and may be hard for some patients to follow consistently.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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110 people
The number who actually took part.
- Started
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Jun 2013
- Expected to finish
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Dec 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Exclusion Criteria: * 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)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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M D Anderson Cancer Center
Houston, Texas, 77030, United States
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