Ignite Creation Date:
2025-12-24 @ 7:25 PM
Ignite Modification Date:
2025-12-25 @ 5:05 PM
Study NCT ID:
NCT03448003
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-15
First Post:
2018-02-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comprehensive Lifestyle Change To Prevent Breast Cancer
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
Comprehensive Lifestyle Change to Prevent Breast Cancer: A Feasibility Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: