This clinical trial investigates whether an individualized counseling program with a registered dietician may help stage 0-III breast cancer survivors reach a healthier weight and improve physical fitness. More than 65% of breast cancer survivors are overweight and less than one-third participate in recommended levels of physical exercise. Obese breast cancer survivors have been found to have greater than a two-fold increase in mortality compared to women with normal body mass index. The individualized counseling program consists of both in-person and telephone-based consults, during which breast cancer survivors are educated in specific nutrition and physical activity guidelines as advised by the American Cancer Society. This program may help stage 0-III breast cancer survivors to achieve improved body weight, composition, and physical fitness, which contribute to overall health.
Additional locations may be listed on ClinicalTrials.gov for NCT04365569.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVE:
I. To determine the efficacy of a six-month, nutrition and exercise counseling program designed to help overweight breast cancer survivors achieve 10% body weight loss.
SECONDARY OBJECTIVES:
I. To assess the effect of the program on body fat percentage.
II. To assess the effect of the program on quality of life.
III. To assess the effect and benefit of the program on extrapolated maximum oxygen uptake levels (VO2 max).
TERTIARY OBJECTIVES:
I. To explore the effect of the intervention on the following correlative biomarkers:
Ia. Lipid profile (triglycerides, low density lipoprotein, high density lipoprotein, and total cholesterol levels).
Ib. Glycemic profile (glycosylated hemoglobin [HbA1c]).
Ic. Serum vitamin D.
Id. Serum C-reactive protein (CRP).
II. To assess the factors associated with adherence to the program.
OUTLINE:
Patients attend a consultation visit with a registered dietician over 45-60 minutes at baseline, during which they receive nutrition and physical activity education encouraging 30 minutes or more of moderate to vigorous intentional physical activity at least five days per week, eating a healthy diet, with emphasis on plant foods, and limiting alcohol intake. Patients also receive educational material on the specifics of a healthy diet per the American Cancer Society Nutrition and Physical activity guidelines. Patients are followed-up by telephone with a registered dietician over 15-30 minutes at 1, 2, 4, and 5 months. Patients also attend in-person follow-up consultations with a registered dietician at 3 and 6 months.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationCase Comprehensive Cancer Center
Principal InvestigatorElizabeth R. Stone
