Clinical trial NCT02037542: A Study of Lifestyle Intervention in Overweight or Obese Women With Early Stage Breast Cancer
Official title: A Study of Lifestyle Intervention in Overweight or Obese Women With Early Stage Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight
Keywords: BMI, Lipid profile
Lead sponsor: Baptist Health South Florida
Sponsor class: OTHER
First posted: 2014-01-16
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to test the hypothesis that an intervention of lifestyle modification will positively impact women with breast cancer who are overweight and/or obese. To that end, our primary endpoint is to examine the effects of a practical lifestyle intervention that can be implemented by overweight or obese women (BMI greater or equal to 25) with early stage breast cancer (I-III) on outcomes such as body weight and change in BMI over the course of the study.

Detailed description: * Primary endpoint: To examine the effects of a practical lifestyle intervention that can be implemented by overweight or obese women (BMI greater or equal to 25) with early stage breast cancer (I-III) on outcomes such as body weight and change in BMI over the course of the study.
* Secondary endpoint: To assess the impact of such intervention on lipid profiles and hemoglobin A1C. The study group will be compared with a historical control group of patients with early stage breast cancer who are obese or overweight who were not given the intervention
* Secondary endpoint: To examine whether an active intervention program will lead into longstanding lifestyle modification in breast cancer patients with a BMI greater or equal to 25.

Eligibility criteria: Inclusion Criteria:

* DCIS
* Women with stage 0 - III breast cancer (histologic type ductal or lobular)
* BMI \>=25
* Patients must have completed all chemotherapy
* Patients may be on hormonal therapy or radiation therapy
* Age \>= 18 years old to 89 Years old
* Patient must be medically stable and without significant impairments that would preclude following the proposed intervention regimen.
* Time of diagnosis: patients enrolled are within 1 month to 18 months post-diagnosis.

Exclusion Criteria:

* Metastatic breast cancer patients and patients with inoperable or active loco-regional disease.
* Patients following alternative/complementary diets or taking high dose antioxidant supplements.
* Patients with a physical/psychiatric impairment that would seriously impair their physical mobility.
* Patients who are currently suffering from severe nausea, anorexia or other diseases affecting health (e.g. arthritis and multiple sclerosis).
* Patients younger than 18 and older than 89 years.

Primary outcomes:
measure: Lifestyle intervention
timeFrame: One year
Secondary outcomes:
measure: Lipid Profiles, hemoglobin A1C
timeFrame: 1 year
Other outcomes:
Locations:
city: Miami
country: United States
facility: South Miami Hospital
state: Florida
Study officials:
affiliation: BHSF
name: Maria Amelia Rodrigues, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dignam JJ, Wieand K, Johnson KA, Fisher B, Xu L, Mamounas EP. Obesity, tamoxifen use, and outcomes in women with estrogen receptor-positive early-stage breast cancer. J Natl Cancer Inst. 2003 Oct 1;95(19):1467-76. doi: 10.1093/jnci/djg060.
citation: Christy SM, Mosher CE, Sloane R, Snyder DC, Lobach DF, Demark-Wahnefried W. Long-term dietary outcomes of the FRESH START intervention for breast and prostate cancer survivors. J Am Diet Assoc. 2011 Dec;111(12):1844-51. doi: 10.1016/j.jada.2011.09.013.
citation: Demark-Wahnefried W, Morey MC, Sloane R, Snyder DC, Miller PE, Hartman TJ, Cohen HJ. Reach out to enhance wellness home-based diet-exercise intervention promotes reproducible and sustainable long-term improvements in health behaviors, body weight, and physical functioning in older, overweight/obese cancer survivors. J Clin Oncol. 2012 Jul 1;30(19):2354-61. doi: 10.1200/JCO.2011.40.0895. Epub 2012 May 21.