Clinical trial · Interventional
Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer
Endometrial Cancer and Obesity: An Exercise and Diet Intervention for Weight Loss
NCT03042897CI-TRIAL-00048944withdrawnN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): PI left institution
Summary
Brief summary (as posted)
This pilot clinical trial studies exercise and diet intervention in promoting weight loss in obese patients with stage I endometrial cancer. Exercise and diet may cause weight loss and minimize the risk of gynecologic surgery related to being overweight in patients with endometrial cancer.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Estrogen Receptor Positive | — | UNRESOLVED | — |
| Obesity | — | UNRESOLVED | — |
| Progesterone Receptor Positive | — | UNRESOLVED | — |
| Stage IA Uterine Corpus Cancer | Malignant Uterine Corpus Neoplasm | CURATED_BROADER | 0.78 |
| Stage IB Uterine Corpus Cancer | Malignant Uterine Corpus Neoplasm | CURATED_BROADER | 0.78 |
| Stage I Uterine Corpus Cancer | Malignant Uterine Corpus Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dietary Intervention | Dietary Supplement | — | UNRESOLVED |
| Exercise Intervention | Behavioral | — | UNRESOLVED |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Supportive Care (exercise and diet)
- description
- Patients undergo aerobic exercise thrice weekly over 95 minutes for up to 16 weeks. Patients also undergo multi-lifestyle interventions based on the DASH diet once weekly over 1 hour for up to 16 weeks.
- interventionNames
- Dietary Supplement: Dietary Intervention
- Behavioral: Exercise Intervention
- Other: Laboratory Biomarker Analysis
- Other: Quality-of-Life Assessment
Primary outcomes (7)
- measure
- Cardiorespiratory Fitness (CRF)
- timeFrame
- Up to 34 weeks
- description
- Subjects will be instructed to walk comfortably (so they are able to talk while walking) on a treadmill for 4 minutes and heart rate will be measured at the end of the test to estimate maximal oxygen uptake.
- measure
- Cardiovascular (CV) health outcomes
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * Clinical stage I EC * Low grade disease positive for estrogen and progesterone receptors * Body mass index (BMI) \>= 30 kg/m\^2 * No history of any musculoskeletal, cardiorespiratory or neurological diseases that preclude the participation in exercise * Self ambulatory and without use of assistive walking devices * Is not a candidate for immediate hysterectomy, following evaluation by a physician, due to desire to preserve fertility, due to degree of obesity, due to comorbidities, or due to patient refusal of hysterectomy * Must agree to take progestin agents (i.e., oral agents or MIRENA intrauterine device \[IUD\] which are accepted treatments for low grade uterine malignancies to control their disease while the intervention is ongoing) * Note: potential participants WILL NOT be asked to delay surgery to participate in this pilot study Exclusion Criteria: * Patients with metastatic disease * BMI =\< 29.9 kg/m\^2 * History of any musculoskeletal, cardiorespiratory or neurological diseases that preclude the participation in exercise * Is not self ambulatory and relies on the use of assistive walking devices * Is a candidate for immediate hysterectomy, following evaluation by a physician * In judgement of a physician, is not a candidate for progestin agents
References
Publications (0)
Data not yet available
No reference posted for this study.