Clinical trial · Interventional
Feasibility of High Levels of Energy Expenditure From Physical Activity for Breast Cancer Survivors
Feasibility of High Levels of Energy Expenditure From Physical Activity During a Weight Loss Intervention for Breast Cancer Survivors
NCT02963740CI-TRIAL-00056146completedN/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 study is to demonstrate that breast cancer survivors who need to lose weight are able to follow a weight loss program which combines modest calorie restriction with a graduated activity program..
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 Female | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Diet | Behavioral | — | UNRESOLVED |
| Group Phone Calls | Behavioral | — | UNRESOLVED |
| Home-based Exercise | Behavioral | — | UNRESOLVED |
| Supervised Exercise | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Weight Loss Intervention Group
- description
- Participants will take part in supervised exercise and home-based exercise sessions. Participants will be asked to follow a specific diet. Participants will be asked to take part in weekly behavioral group phone calls.
- interventionNames
- Behavioral: Supervised Exercise
- Behavioral: Home-based Exercise
- Behavioral: Group Phone Calls
- Behavioral: Diet
Primary outcomes (1)
- measure
- Adherence to supervised exercise sessions
- timeFrame
- Week 12
- description
- Adherence is defined as the percent of monitored sessions at the YMCA attended by the participant.
Secondary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Maximum age
- 71 Years
Show eligibility criteria text
Inclusion Criteria: * Women \< age 71 in good general health. * Prior diagnosis of breast cancer. * At least 3 months from completion of any cytotoxic chemotherapy or radiation or surgery. May continue to take endocrine therapy and/or maintenance trastuzumab. * Body Mass Index (BMI) 30-45 kg/m2. * By self-assessment, currently performing 60 minutes or less of purposeful exercise per week but able to walk at least 30 minutes on a level surface. * Access to a smart phone capable of running MyFitnessPal and Garmin Connect apps and willing to have diet and exercise data from these apps viewed by study personnel. * Live in the greater Kansas City Metropolitan Area * Willing and able to perform moderate intensity exercise at least 5 days per week for 3 months. * Willing to perform unsupervised home exercise for the entire 3 months. * Willing to participate in a weekly behavioral modification group phone call for 3 months. * Willing to participate in a controlled dietary intervention with portion controlled meals and partial meal and track food intake and exercise. Exclusion Criteria: * Use of metformin, insulin, steroids or weight loss or anti-psychotic drugs within the prior 3 weeks * Individuals with prior bariatric surgery procedures * Need for chronic immunosuppressive drugs * Participation within the past 6 months on a structured weight loss program such as Weight Watchers® * Physical impairments (bad hip, knees, feet, peripheral neuropathy) that would prohibit performing moderate intensity exercise at least 5 days per week. * Any other condition or intercurrent illness that in the opinion of the investigator makes the subject a poor candidate for participation in the trial such as recent cardiac event. * Currently receiving investigational agents in a clinical trial.
References
Publications (1)
- RESULTFabian CJ, Klemp JR, Marchello NJ, Vidoni ED, Sullivan DK, Nydegger JL, Phillips TA, Kreutzjans AL, Hendry B, Befort CA, Nye L, Powers KR, Hursting SD, Giles ED, Hamilton-Reeves JM, Li B, Kimler BF. Rapid Escalation of High-Volume Exercise during Caloric Restriction; Change in Visceral Adipose Tissue and Adipocytokines in Obese Sedentary Breast Cancer Survivors. Cancers (Basel). 2021 Sep 28;13(19):4871. doi: 10.3390/cancers13194871. PMID 34638355