Clinical trial NCT01217216: Cancer Survival Through Weight Loss and Exercise
Official title: Cancer Survival Through Weight Loss and Exercise (CASTLE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer Survivors
Keywords: Breast Cancer
Weight loss
Group Intervention
Telephone Intervention
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
First posted: 2010-10-08
Enrollment: 52
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To test the effectiveness and feasibility of intensive motivational, behavior modifying intervention aimed at improving physical activity and dietary habits to produce at least 7% weight loss in women with a history of breast cancer in a community health setting.

Detailed description: This study will be divided into two phases (Phase I and II) that will differ by the intensity of motivational intervention. In Phase I, participants will receive 6 months of intensive weekly group-based or telephone-based motivational, behavior modifying intervention aimed at improving physical activity levels and dietary habits. Phase II will be an additional 6 months of monthly individualized motivational intervention in order to attain and maintain at least 7% body weight loss. All participants will attend an orientation, 2 run-in sessions, and a baseline assessment prior to the intervention. Participants will then be assigned to either the group based intervention or telephone intervention. The first 30 participants will enter into the group-based intervention and the second 30 will enter into the telephone-based intervention. Follow-up visits will be completed at the end of Phase I (week 25) and Phase II (week 50). Up to 60 women with a previous history of breast cancer will participate in this study.

Eligibility criteria: Inclusion Criteria:

* Women between the ages of 30 and 75.
* Positive history of breast cancer treatment completed at least 2 months but no longer than 36 months prior to randomization.
* BMI ≥ 25 kg/m2 and ≤ 45 kg/m2
* Not involved in regular physical activity or weight loss management programs.
* Stage I, II or IIIa breast cancer with good prognosis.

Exclusion Criteria:

* Presence of any co-morbidities including cardiovascular disease or diabetes
* Fasting triglycerides \> 500 mg/dl.
* Consume more than 14 alcoholic beverages per week.
* A history of drug abuse, or excess alcohol consumption (40g/day)6.
* Currently dieting or engaging in any activity with the goal of losing weight.
* Significant intentional weight loss in the past year (\> 50 lbs in the past year) or current use of weight loss medications.
* History of gastrointestinal bypass or other bariatric surgery in the last 3 years.
* Pregnant or plan on becoming pregnant in the next 12 months.
* Factors that may limit adherence to intervention or affect conduct of the trial.
* Unable or unwilling to communicate with staff, to provide written informed consent, or accept the randomized assignment.
* Failure to complete run-in and baseline testing.
* Lack support from health care provider or family members.
* Other temporary intervening event, such as sick spouse, bereavement, or recent move.
* Any other medical condition or disease that is life threatening or that can interfere with or be aggravated by exercise.
* Current diagnosis of schizophrenia, other psychotic disorders, or bipolar disorder.
* Any other condition, which, in the opinion of the investigators would impede competence or compliance or possibly hinder completion of the study.

Primary outcomes:
measure: Weight loss
timeFrame: 1 year
Secondary outcomes:
measure: Feasibility of recruiting breast cancer survivors
timeFrame: 1 year
measure: Examination of health outcomes, breast cancer reoccurrence, and mortality.
timeFrame: 1 year
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
affiliation: Pennington Biomedica Research Center
name: Timothy S Church, MD, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pennington Biomedical Research Center
name: Donna H Ryan, MD
role: STUDY_DIRECTOR
affiliation: Pennington Biomedical Research Center
name: Conrad P Earnest, PhD
role: STUDY_DIRECTOR
affiliation: Pennington Biomedical Research Center
name: Valerie H Myers, PhD
role: STUDY_DIRECTOR
affiliation: Pennington Biomedical Research Center
name: Catherine M Champagne, PhD
role: STUDY_DIRECTOR
References:
citation: Harris MN, Swift DL, Myers VH, Earnest CP, Johannsen NM, Champagne CM, Parker BD, Levy E, Cash KC, Church TS. Cancer survival through lifestyle change (CASTLE): a pilot study of weight loss. Int J Behav Med. 2013 Sep;20(3):403-12. doi: 10.1007/s12529-012-9234-5.