Clinical trial · Interventional
Reducing Breast Cancer Recurrence With Weight Loss
Reducing Breast Cancer Recurrence With Weight Loss: A Vanguard Trial
NCT01112839CI-TRIAL-00018289ENERGYcompletedN/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 the ENERGY trial is to explore whether two different programs that are focused on weight management, through increased exercise and a healthy diet, are feasible, and have an impact on body weight, quality of life and fatigue. Since obesity among breast cancer survivors is associated with recurrence and other co-morbidities, those will be assessed and their impact calculated. Blood samples will be collected to enable analysis of potential mechanisms and differential response across subgroups.
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 |
|---|---|---|---|
| Intensive Group | Behavioral | — | UNRESOLVED |
| Less Intensive | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Less Intensive Group
- description
- Participants in this group would receive print materials on diet and exercise and two individual counseling sessions; one at the beginning of the study and another 6 months later.
- interventionNames
- Behavioral: Less Intensive
- type
- EXPERIMENTAL
- label
- Intensive Group
- description
- Participants in this group would receive print materials on diet and exercise and attend group sessions that would meet weekly for the first 4 months, then every two weeks for the next 2 months, and then monthly for the next 6 months over the course of one year.
- interventionNames
- Behavioral: Intensive Group
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of breast cancer (stages I (≥1 cm), stage II, or stage IIIA, B, C excluding distant metastasis) diagnosed between 6 months and 5 years earlier; after initial therapies are completed, diagnosed between six months and five years earlier * BMI between 25 to 45 kg/m2 * Able to comply with all required study procedures and schedule Exclusion Criteria: * Serious medical condition or psychiatric illness * Inability to be moderately physically active * Obesity of known endocrine origin (e.g., untreated hypothyroidism, PCOS) * Currently enrolled in a weight loss program * Current use of weight loss medication or supplements * Previous surgical procedures for weight reduction * Planning weight loss surgery in the next 2 years. * 6+ months use of meds likely to cause weight gain or prevent weight loss * Planned surgical procedure that can impact the conduct of the study * Currently pregnant/breastfeeding * Planning to become pregnant within the next 2 years * Have plans to relocate from area within 2 years * Family relative or close friend is a trial staff member or a study participant * Any condition which in the opinion of the investigator makes the subject unsuitable for inclusion in this study
References
Publications (2)
- DERIVEDKenzik KM, Demark-Wahnefried W, Ganz PA, Colditz G, Rock CL, Rogers LQ. Changes in Body Mass Index and Physical Activity Predict Changes in Vitality During a Weight Loss Trial in Breast Cancer Survivors. Ann Behav Med. 2018 Nov 12;52(12):999-1009. doi: 10.1093/abm/kay004. PMID 29617707
- DERIVEDRock CL, Flatt SW, Byers TE, Colditz GA, Demark-Wahnefried W, Ganz PA, Wolin KY, Elias A, Krontiras H, Liu J, Naughton M, Pakiz B, Parker BA, Sedjo RL, Wyatt H. Results of the Exercise and Nutrition to Enhance Recovery and Good Health for You (ENERGY) Trial: A Behavioral Weight Loss Intervention in Overweight or Obese Breast Cancer Survivors. J Clin Oncol. 2015 Oct 1;33(28):3169-76. doi: 10.1200/JCO.2015.61.1095. Epub 2015 Aug 17. PMID 26282657