Clinical trial · Interventional
Endometrial Cancer Diet and Exercise
Physical Activity and Nutrition Counseling Intervention in Endometrial Cancer Survivors
NCT02987881CI-TRIAL-00053022completedN/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)
This study will evaluate whether the use of the Jawbone wristband monitor, in connection with home-based exercise and nutritional counseling can be safely completed and improve cardiorespiratory fitness (heart and lung health) in women with early stage endometrial cancer who have undergone surgery.
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 |
|---|---|---|---|
| Early Stage Endometrial Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Home-based aerobic exercise and nutritional counseling | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Adult women with early stage localized endometrial cancer
- description
- Adult women with early stage localized endometrial cancer at least 2 months following hysterectomy
- interventionNames
- Behavioral: Home-based aerobic exercise and nutritional counseling
Primary outcomes (7)
- measure
- Feasibility as measured by adherence to weekly walking sessions
- timeFrame
- Week 12
- description
- Percentage of daily steps divided by total number of steps and daily walking sessions divided by total number of sessions prescribed
- measure
- Safety as measured by the type and prevalence of adverse events during study-related assessments
- timeFrame
- Week 12
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Ages \> 18 years. * Localized endometrial cancer (stage I and II); no evidence of stage III or IV disease. * At least 2 months was passed since the hysterectomy and enrollment. * Karnofsky performance status \> 70%. * Body mass index of 30.0 - 49.9 and body weight \< 300 pounds. * No plan for adjuvant endometrial cancer therapy. * Able to exercise safely on a treadmill. * No absolute contraindications to exercise testing as recommended by the American Thoracic Society. No recent (\<6 months) acute cardiac event unstable angina, uncontrolled dysrhythmias causing symptoms or hemodynamic compromise, symptomatic aortic stenosis, uncontrolled symptomatic heart failure, acute pulmonary embolus, acute myocarditis or pericarditis, suspected or known dissecting aneurism and acute systemic infection. * The subject is not participating in regular physical exercise (more than 60 minutes of moderate intensity or 30 minutes of vigorous intensity exercise per week) or weight reduction dieting. * Able to provide informed consent. * Have reliable transportation to the testing facilities. * Subjects must be able to speak and understand English to participate in this study. * Subjects must have a personal mobile device compatible for the activity monitor Compatible devices for the activity monitors are below: * Android o Activity monitor is compatible with most Android devices equipped with Bluetooth 4.0 and running Android 4.3 (Jelly Bean) or later. * iOS * iPhone 4s (or newer) * iPod touch (5th generation or newer) * iPad (3rd generation or newer) * iPad mini (1st generation or newer) * iPad Air (1st generation or newer) Exclusion Criteria: \-
References
Publications (1)
- RESULTSchwartz AR, Bartlett DB, Johnson JL, Broadwater G, Channell M, Nolte KC, Wilkes PA, Huffman KM, Secord AA. A Pilot Study of Home-Based Exercise and Personalized Nutrition Counseling Intervention in Endometrial Cancer Survivors. Front Oncol. 2021 Jun 11;11:669961. doi: 10.3389/fonc.2021.669961. eCollection 2021. PMID 34178654