Clinical trial NCT02079662: The Role of Lifestyle Factors in Breast Cancer-Related Outcomes
Official title: Integrative Oncology Program in Improving Cancer-Related Outcomes in Patients With Stage II or III Breast Cancer Undergoing Radiation Therapy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: 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
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2014-03-06
Enrollment: 110
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: PRIMARY OBJECTIVES:

I. Determine whether the Integrative Oncology group (IO) has increased disease-free survival (time to recurrence) than the standard of care control group (SC).

II. Compare group differences over time in biological pathways including: immune function, endocrine function, insulin and glucose metabolism, cancer-related pathways (from peripheral blood), antioxidant capacity, and nutrient levels.

III. Examine group differences in overall survival. IV. Compare group differences over time in dietary patterns and fitness levels. V. Determine whether the IO group has improved patient reported outcomes including fatigue, sleep disturbances, radiotherapy toxicity (dermatitis, skin ulceration, pruritis, etc.), gut microbiome, other aspects of Quality of Life (QOL), mental health, social support, and measures of positive growth.

VI. Compare group differences over time in heart rate variability. VII. Determine cost-effectiveness analysis and work and/or home productivity.

SECONDARY OBJECTIVES:

I. Compare group differences over time in healthy breast tissue biomarkers acquired from fine needle aspirations.

II. Compare group differences in spouse or caregiver work productivity.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: 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.

ARM II: Patients undergo standard of care.

After completion of study treatment, patients are followed up at 6 and 12 months and then annually for up to 4 years.

Eligibility criteria: 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)

Primary outcomes:
measure: Disease-free survival (DFS)
timeFrame: Up to 5 years
measure: Changes in biological pathways
timeFrame: Baseline to 5 years
measure: Changes in dietary patterns
timeFrame: Baseline to 5 years
measure: Changes in fitness levels
timeFrame: Baseline to 5 years
measure: Changes in heart rate variability
timeFrame: Baseline to 5 years
measure: Changes in quality of life (including fatigue and sleep disturbances)
timeFrame: Baseline to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Lorenzo Cohen
role: PRINCIPAL_INVESTIGATOR
References: