Prehabilitation program for elderly cancer patients undergoing chemotherapy
Prehabilitation for Elderly Patients With Advanced Epithelial Ovarian, Fallopian Tube, Primary Peritoneal Carcinoma and Pancreatic Cancer Undergoing Neoadjuvant Chemotherapy
This study tests if a special program that includes exercise and nutrition can help older cancer patients feel better and recover faster before their surgery while they are getting chemotherapy.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 22 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Case Comprehensive Cancer Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT06412510 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of a multimodal prehabilitation intervention on elderly patients with advanced epithelial ovarian cancer and pancreatic adenocarcinoma who are receiving neoadjuvant chemotherapy. The intervention focuses on exercise and nutrition to enhance physical fitness and functional outcomes before surgery. The goal is to determine if prehabilitation can improve patients' quality of life, reduce complications, and enhance recovery compared to standard care. The study aims to fill a gap in knowledge regarding the benefits of prehabilitation in this specific patient population.
Who should consider this trial
Good fit: Ideal candidates are elderly patients aged 65 and older with advanced epithelial ovarian cancer or pancreatic adenocarcinoma undergoing neoadjuvant chemotherapy.
Not a fit: Patients with severe comorbidities, physical immobility, or a life expectancy of less than three months may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve recovery and quality of life for elderly cancer patients undergoing chemotherapy and surgery.
How similar studies have performed: Previous studies have shown that prehabilitation can improve outcomes in surgical patients, but this specific application in elderly cancer patients undergoing chemotherapy is novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Cleveland, Ohio
- Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Mariam AlHilli, MD — Cleveland Clinic Foundation, Case Comprehensive Cancer Center
- Study coordinator: Mariam AlHilli, MD
- Email: alhillm@ccf.org
- Phone: 216-644-0418
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.