Clinical trial · Interventional
Prehabilitation for EOC, Fallopian Tube, Primary Peritoneal Carcinoma and Pancreatic Cancer w/ NACT
Prehabilitation for Elderly Patients With Advanced Epithelial Ovarian, Fallopian Tube, Primary Peritoneal Carcinoma and Pancreatic Cancer Undergoing Neoadjuvant Chemotherapy
NCT06412510CI-TRIAL-00105827active not recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 16, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260916-000001
Summary
Brief summary (as posted)
The purpose of this study is to see whether participants who are assigned to a multimodal prehabilitation intervention during chemotherapy are able to adhere with exercise and nutrition program to prepare for their cancer surgery.
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 |
|---|---|---|---|
| Epithelial Ovarian Cancer | Ovarian Carcinoma | ALIAS | 0.90 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Pancreatic Adenocarcinoma | Pancreatic Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Prehabilitation | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention - Arm 1
- description
- Exercise Intervention: Participants will be referred to Langston Hughes Community Center and work with exercise physiologists who will utilize our SmartGym ecosystem in providing exercise assessments, prescriptions, and training. Nitrition Intervention: Participants in the intervention group will be provided with 1-2 bottles of high protein oral nutritional supplements daily (ONS) to ensure that protein needs are met daily. There will be two options of ONS to choose from: one option a high calorie, high protein supplement, and the other option a low fat/low sugar, high protein supplement. Supportive care/Mind-body intervention: Participants will have access to Taussig Cancer Institute Patient Support services that are offered for free.
- interventionNames
- Other: Prehabilitation
- type
- NO_INTERVENTION
- label
- Control - Arm 2
- description
- Exercise: Standard of care. Level of activity will be reported and monitored at each visit through study coordinator assessment and patient interview. Nutrition: Participants will be referred to dietitian and will be seen for a baseline evaluation, as needed throughout treatment and post treatment. A full nutrition assessment will be performed, and malnutrition diagnosis will be documented. When no malnutrition is identified participants will be provided general nutrition counseling related to their cancer type, cancer treatment, and recommendations for symptom management as needed. Those participants identified to be malnourished to any degree will receive personalized medical nutrition therapy including nutrition interventions to improve caloric intake. Supportive care/Mind-body intervention: Per standard of care, participants will be offered support services from Taussig Cancer Institute program.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Age 65 and older * Patients with diagnosis of advanced (Stage III or IV) epithelial ovarian, fallopian tube, or * Patients with diagnosis of pancreatic adenocarcinoma (PDAC) (Stage I, II, or III) undergoing neoadjuvant chemotherapy. * Patients with locally advanced esophageal cancer undergoing neoadjuvant chemotherapy. * Patients with locally advanced muscle invasive bladder cancer undergoing neoadjuvant chemotherapy. Exclusion Criteria: * Life expectancy less than 3 months in the opinion of the treating physician * Patients unable to provide informed consent. * Wheelchair bound patients/ physical immobility. * Severe cardiopulmonary disease defined as NYHA class III or IV * Patients with malignant bowel obstruction who will require surgical intervention or nutritional support in the form of enteral or parenteral nutrition will also be excluded. * Patients with any other comorbidity or condition, which, in the opinion of the enrolling investigator, would place the patient at unnecessarily higher greater risk or burden, or participating in the study would not be in the best interests of the patient.
References
Publications (0)
Data not yet available
No reference posted for this study.