Clinical trial · Interventional
Trial of Exercise and Lifestyle for Women With Ovarian and Endometrial Cancer
Trial of Exercise and Lifestyle (TEAL) for Women With Ovarian and Endometrial Cancer
- 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)
An anticipated 200 women with newly diagnosed ovarian and endometrial cancer scheduled to receive chemotherapy (adjuvant chemotherapy after surgery or neoadjuvant chemotherapy before surgery) will be recruited from Smilow Cancer Hospital Network at Yale Cancer Center (YCC) and Sylvester Comprehensive Cancer Center (SCCC) at University of Miami. Participants will be randomized to an exercise and medical nutrition intervention arm with weekly counseling sessions throughout chemotherapy, or a control arm. Study assessments will be conducted at baseline, post-chemotherapy/end of intervention and at 1-year post diagnosis. Women who are prescribed neoadjuvant therapy will have additional assessments prior to surgery. Data required to calculate the primary endpoint (relative dose intensity of chemotherapy) will be abstracted from the medical record directly following each chemotherapy session.
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 |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Exercise and medical nutrition | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Exercise and medical nutrition
- description
- Over the intervention period (18 weeks on average - dependent on length of chemotherapy) women in the intervention arm will receive weekly counseling sessions, the study dietitian and exercise trainer will each conduct weekly sessions to assist the participants in achieving the diet and exercise study goals.
- interventionNames
- Behavioral: Exercise and medical nutrition
- type
- NO_INTERVENTION
- label
- Control
- description
- Contact limited to study assessments.
Primary outcomes (1)
- measure
- Chemotherapy completion rate (relative dose intensity)
- timeFrame
- Through end of first line chemotherapy, an average of 5 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * have a diagnosis of epithelial ovarian cancer, fallopian tube or primary peritoneal carcinoma, stage I-IV OR have a diagnosis of advanced or metastatic endometrial carcinoma (including carcinosarcoma) AND their treatment regimen includes carboplatin and taxane (or equivalent) * be scheduled to receive at least 6 cycles of neoadjuvant or adjuvant chemotherapy * be physically able to walk without a walking aid (e.g. cane or walker) * be able to complete forms, understand instructions and read intervention book in English or Spanish * agree to be randomly assigned to either group * have clearance from oncologist to participate * be ≥ 18 years of age Exclusion Criteria: * having already completed a 2nd cycle of chemotherapy * already practicing dietary (\>7 servings of fruits and vegetables per day) OR physical activity guidelines (≥150 min per week of moderate to vigorous exercise and resistance training two times per week) since diagnosis * pregnancy or intention to become pregnant * recent (past year) stroke/myocardial infarction or congestive heart failure/ejection fraction \<40% * presence of dementia or major psychiatric disease * in active treatment including target or biologic therapies for any other cancer (excluding hormone therapy treatments) * receiving external beam radiation
References
Publications (0)
Data not yet available