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NCT06412510 | RECRUITING | Ovarian Cancer

Prehabilitation for EOC, Fallopian Tube, Primary Peritoneal Carcinoma and Pancreatic Cancer w/ NACT
Sponsor:

Case Comprehensive Cancer Center

Brief Summary:

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.

Condition or disease

Ovarian Cancer

Epithelial Ovarian Cancer

Pancreatic Adenocarcinoma

Intervention/treatment

Prehabilitation

Phase

PHASE1

PHASE2

Detailed Description:

Elderly participants with epithelial ovarian cancer (EOC) and pancreatic adenocarcinoma (PDAC) undergoing neoadjuvant chemotherapy (NACT) are often frail and malnourished. Both chemotherapy and disease burden are associated with a decline in muscle mass leading to decrease in physical strength and cardiovascular fitness. Limited efforts have focused on decreasing morbidity at time of chemotherapy and surgery and improving functional capacity. Exercise during chemotherapy has been shown to improve chemotherapy related symptoms and quality of life in participants with breast cancer participants. In surgical patient populations, preoperative rehabilitation (prehabilitation) has been shown to improve walking capacity, decrease hospital length of stay, perioperative complications, and cost. However, whether multimodal prehabilitation improves the functional capacity and perioperative outcomes of EOC and PDAC participants undergoing NACT compared to standard of care is unknown. Investigators aim to evaluate if prehabilitation in participants with EOC and PDAC undergoing NACT improves physical fitness/ functional outcomes, perioperative outcomes, nutritional status, and quality of life compared to standard of care.

Study Type : INTERVENTIONAL
Estimated Enrollment : 22 participants
Masking : NONE
Primary Purpose : SUPPORTIVE_CARE
Official Title : Prehabilitation for Elderly Patients With Advanced Epithelial Ovarian, Fallopian Tube, Primary Peritoneal Carcinoma and Pancreatic Cancer Undergoing Neoadjuvant Chemotherapy
Actual Study Start Date : 2025-09-05
Estimated Primary Completion Date : 2026-09
Estimated Study Completion Date : 2026-09

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 65 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.
Prehabilitation for EOC, Fallopian Tube, Primary Peritoneal Carcinoma and Pancreatic Cancer w/ NACT

Location Details

NCT06412510

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How to Participate

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Locations

RECRUITING

United States, Ohio

Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Cleveland, Ohio, United States, 44195