Clinical trial NCT03448003: Comprehensive Lifestyle Change To Prevent Breast Cancer
Official title: Comprehensive Lifestyle Change to Prevent Breast Cancer: A Feasibility Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Premenopausal
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2018-02-27
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This trial studies how well comprehensive lifestyle change works in preventing patients from breast cancer. A program including dietary recommendations, physical activity, stress management and mindfulness training, learning sleep hygiene techniques, and behavioral counseling in addition to social support may help patients who may be at risk for breast cancer.

Detailed description: PRIMARY OBJECTIVES:

I. Assess the feasibility of a randomized controlled trial involving a mobile, standardized, comprehensive integrative oncology (IO) prevention program.

SECONDARY OBJECTIVES:

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

II. Determine whether the IO group has improved patient reported outcomes over time including: quality of life, sleep disturbances, aspects of mental health, and psychosocial measures including: mindfulness, social support, and measures of positive growth.

III. Compare group differences over time in dietary patterns, fitness levels, percent body fat, and anthropometrics.

OUTLINE: Patients are randomized into 1 of 2 groups.

GROUP I: Patients attend IO prevention program consisting of 1-2 physical activity, nutrition and diet, and mind-body practice sessions over 60 minutes weekly for 12 weeks. Patients also attend a behavioral counseling session once weekly for up to 26 weeks. Patients complete exercises over 30-60 minutes 3-5 times weekly for 12 weeks.

GROUP II: Patients receive no intervention. After 26 weeks, patients may crossover to Group I.

After completion of study, patients are followed up at 26 weeks and 1 year.

Eligibility criteria: Inclusion Criteria:

* Able to read, write, and speak English
* Premenopausal
* A body mass index (BMI) \>= 25
* Have intact breasts and ovaries
* Able to provide informed consent to participate in the study
* Meet all the following criteria related to lifestyle: a) consume less than 3 servings of vegetables (excluding any fried servings) and 1 serving of fruit (not including juice)/day; b) engage in less than 150 minutes moderate/vigorous intensity 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); c) engage in a mind-body practice less once per week
* Able mentally and physically to participate in interventions in this study (Note: If there are one or more positive responses to the Physical Activity Readiness Questionnaire \[PARQ\], then a physician-release for exercise is required prior to obtaining consent)
* Access to internet connection
* Able to come to University of Texas (UT) MD Anderson for the orientation and assessment sessions

Exclusion Criteria:

* Any personal history of cancer, including ductal carcinoma in situ (DCIS) and not including non-melanoma skin cancers
* Any major thought disorder (e.g., schizophrenia, dementia)
* Communication barriers (e.g. hard of hearing)
* Poorly or uncontrolled diabetes in the opinion of the physician(s)
* Being pregnant or planning on becoming pregnant within the next year
* Contemplating any new pharmacologic/hormonal or prophylactic surgical intervention for breast cancer prevention within the next year (Note: Individuals taking tamoxifen, arimidex or other hormonal prevention strategies at time of consent will be eligible)

Primary outcomes:
measure: Consent rate
timeFrame: Up to 1 year
measure: Treatment group compliance rate
timeFrame: Up to 1 year
measure: Retention rate
timeFrame: Up to 1 year
Secondary outcomes:
measure: Group differences over time in biological pathways
timeFrame: Up to 1 year
measure: Group differences over time in dietary patterns
timeFrame: Up to 1 year
measure: Group differences over time in fitness levels
timeFrame: Up to 1 year
measure: Group differences over time in percent body fat
timeFrame: Up to 1 year
measure: Group differences over time in anthropometrics
timeFrame: Up to 1 year
measure: Gut microbiome
timeFrame: Up to 1 year
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: