Clinical trial · Interventional
Weight Loss Pilot Study in Postmenopausal Breast Cancer Survivors
NCT02940470CI-TRIAL-00034129completedN/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)
The primary objective of this pilot study is to determine the effect of weight loss on a wide range of biomarkers associated with risk of breast cancer recurrence in overweight and obese breast cancer survivors. We hypothesized that weight loss would result in a statistically significant improvement in biomarkers associated with risk of breast cancer recurrence.
Conditions
Conditions (3)
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 | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Obesity | — | UNRESOLVED | — |
| Overweight | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Calorie restricted diet plus exercise | Other | — | UNRESOLVED |
| Weight management classes | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Calorie restricted diet plus exercise
- description
- See Intervention Description
- interventionNames
- Other: Calorie restricted diet plus exercise
- type
- ACTIVE_COMPARATOR
- label
- Weight management classes
- description
- See Intervention Description
- interventionNames
- Other: Weight management classes
Primary outcomes (1)
- measure
- Change in body weight
- timeFrame
- 0, 6, 12, 18 weeks
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 44 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * postmenopausal (defined as experiencing at least 12 months without a menstrual period) * diagnosed with operable invasive breast cancer and treated with mastectomy or with lumpectomy and radiation * completed all surgery, radiation, and systemic chemotherapy one to 12 months prior to enrollment * BMI ≥ 27 kg/m2 * less than 7 servings of alcohol per week * willing to be randomized into either group * not planning to move away from the area during the period of study * non-smoker Exclusion Criteria: * serious illness requiring medical treatment * inability to participate in physical activity due to severe disability * history of schizophrenia, psychosis or untreated major depression * unwilling to commute to study site once per week * failure to provide written informed consent
References
Publications (1)
- DERIVEDArikawa AY, Kaufman BC, Raatz SK, Kurzer MS. Effects of a parallel-arm randomized controlled weight loss pilot study on biological and psychosocial parameters of overweight and obese breast cancer survivors. Pilot Feasibility Stud. 2017 Jul 10;4:17. doi: 10.1186/s40814-017-0160-9. eCollection 2018. PMID 28702218