Ovarian Cancer Clinical Trial

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

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.

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Full 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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Age 65 and older
Patients with diagnosis of advanced (Stage III or IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer (EOC) undergoing neoadjuvant chemotherapy; OR Patients with diagnosis of pancreatic adenocarcinoma 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.

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

30

Study ID:

NCT06412510

Recruitment Status:

Not yet recruiting

Sponsor:

Case Comprehensive Cancer Center

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There is 1 Location for this study

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Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
Cleveland Ohio, 44195, United States More Info
Mariam AlHilli, MD
Contact
Mariam AlHilli, MD
Principal Investigator

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Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

30

Study ID:

NCT06412510

Recruitment Status:

Not yet recruiting

Sponsor:


Case Comprehensive Cancer Center

How clear is this clinincal trial information?

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