Clinical trial · Interventional
Cancer Survival Through Weight Loss and Exercise
Cancer Survival Through Weight Loss and Exercise (CASTLE)
NCT01217216CI-TRIAL-00060873CASTLEcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Survivors | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Group-based Intervention | Behavioral | — | UNRESOLVED |
| Telephone-based Intervention | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Group-based Intervention
- description
- We randomly assigned 30 individuals to a group-based intervention to promote weight loss through dietary restriction and physical activity.
- interventionNames
- Behavioral: Group-based Intervention
- type
- ACTIVE_COMPARATOR
- label
- Telephone-based Intervention
- description
- We randomly assigned 22 individuals to the telephone-based intervention to promote weight loss through dietary restriction and physical activity.
- interventionNames
- Behavioral: Telephone-based Intervention
Primary outcomes (1)
- measure
- Weight loss
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (1)
- RESULTHarris 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. PMID 22535636