Clinical trial NCT00811824: Effects of Physical Activity and Dietary Change in Minority Breast Cancer Survivors
Official title: Effects of Physical Activity and Dietary Change in Minority Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: Weight loss
Physical activity
Dietary change
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2008-12-19
Enrollment: 42
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: This study is testing the effects of exercise and dietary change on weight reduction and biological markers associated with breast cancer risk in breast cancer survivors of Hispanic or African descent (n=45). This is a randomized, crossover pilot and feasibility study to test the effects of a 30-minute circuit-based exercise program that combines resistance training with aerobic exercise in conjunction with a low-fat calorie reduced diet. Participants will be randomized to either an immediate 6-months of exercise and dietary change, or a delayed group who will begin their exercise and dietary change program 6-months after the study begins. Participants in the immediate group will be followed for an additional 6-months in order to evaluate adherence to the exercise and dietary change recommendations. Participants in both groups will exercise at a neighborhood Curves® facility at least 5 times per week for six months and will participate in a series of nutrition education classes.


Eligibility criteria: Inclusion Criteria:

* 21-70 yrs
* Stage 0-IIIa breast cancer
* No evidence of recurrent/metastatic disease
* Hispanic or African descent (African-American or Caribbean)
* BMI \> 25kg/m2
* Sedentary
* Completed surgery, chemotherapy, and radiation therapy ≥ 6 months
* Blood pressure \< 140/90
* HgbA1C \< 8
* LDL cholesterol \< 150
* No uncontrolled comorbidities
* VO2 max normal EKG changes
* Non-smoker

Exclusion Criteria:

* Evidence of recurrent or metastatic breast cancer
* Uncontrolled co-morbid illness including, but not limited to, type I diabetes mellitus, type II diabetes mellitus, hypertension, symptomatic congestive heart failure, unstable angina pectoris, claudication, cardiac arrhythmia; active pulmonary disease; hypercholesterolemia, neurological condition, ischemic heart disease, cardiac disease, kidney disease, respiration problems, asthma, shortness of breath, physical limitations, abnormal thyroid function, active malignancy, except for squamous or basal cell carcinoma of the skin; receiving active chemotherapy or radiotherapy; or psychiatric illness/social situations that would limit compliance with study requirements
* Currently taking Herceptin therapy, or abnormal echo or MUGA post-Herceptin therapy
* Active tobacco use
* Currently active in an exercise and/or dietary change weight loss program
* If a participant develops a breast cancer recurrence or metastasis during the 12-month study period, her participation in the study will be terminated.

Primary outcomes:
measure: Change in weight
timeFrame: 6 months, 12 months
measure: Intervention adherence
timeFrame: 6 months, 12 months
Secondary outcomes:
measure: Barriers to participation
timeFrame: 3 months, 6 months, 9 months, 12 months
measure: Predictors of adherence
timeFrame: 3 months, 6 months, 9 months, 12 months
measure: Changes in anthropometric measures
timeFrame: 3 months, 6 months, 9 months, 12 months
measure: Changes in fitness
timeFrame: 3 months, 6 months, 9 months, 12 months
measure: Changes in hormonal biomarkers
timeFrame: 3 months, 6 months, 9 months, 12 months
measure: Changes in metabolic markers
timeFrame: 3 months, 6 months, 9 months, 12 months
measure: Changes in psychological and quality of life measures
timeFrame: 3 months, 6 months, 9 months, 12 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University
state: New York
Study officials:
affiliation: Columbia University
name: Heather Greenlee, ND, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Delgado-Cruzata L, Zhang W, McDonald JA, Tsai WY, Valdovinos C, Falci L, Wang Q, Crew KD, Santella RM, Hershman DL, Greenlee H. Dietary modifications, weight loss, and changes in metabolic markers affect global DNA methylation in Hispanic, African American, and Afro-Caribbean breast cancer survivors. J Nutr. 2015 Apr;145(4):783-90. doi: 10.3945/jn.114.202853. Epub 2015 Feb 4.