Clinical trial · Interventional
A Study of Lifestyle Intervention in Overweight or Obese Women With Early Stage Breast Cancer
NCT02037542CI-TRIAL-00023180completedN/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 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.
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 |
|---|---|---|---|
| Weight | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Diet and exercise | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diet and Exercise
- description
- Prospective, observational, cohort study, with a proposed start date of May 2013 and proposed end date of June 2018. Our goal is to gather data on a total of 200 patients: 100 patients (study group) will be prospectively enrolled, while data on another 100 patients (control) will be accessed through retrospective data collection. Number of patients to be analyzed will depend on enrollment and patient compliance. We would like to enroll the proposed 100 patients in the first 1-3 years of the study (approximately 30 per year).
- interventionNames
- Behavioral: Diet and exercise
Primary outcomes (1)
- measure
- Lifestyle intervention
- timeFrame
- One year
- description
- 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 outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 89 Years
Show eligibility criteria text
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.
References
Publications (3)
- BACKGROUNDDignam 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. PMID 14519753
- BACKGROUNDChristy 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. PMID 22117660
- BACKGROUNDDemark-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. PMID 22614994