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Trial Title:
Prehabilitation for EOC, Fallopian Tube, Primary Peritoneal Carcinoma and Pancreatic Cancer w/ NACT
NCT ID:
NCT06412510
Condition:
Ovarian Cancer
Epithelial Ovarian Cancer
Pancreatic Adenocarcinoma
Conditions: Official terms:
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Conditions: Keywords:
Ovarian Cancer
Neoadjuvant chemotherapy
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Prehabilitation
Description:
Exercise Intervention: SmartGyms, band or smartphone used to scan into the TechnoGym
MyWellness kiosk, which controls the TechnoGym Excite Live and Biostrength equipment. The
exercise session will consist of a program that adheres to the FITT (Frequency,
Intensity, Timing, and Type) exercise prescription in accordance with ACSM 2018 ACSM
Roundtable recommendations for Physical Function for combined Aerobic and Resistance
training.
Nutrition Intervention: 30 gm protein supplement
Supportive care/Mind-body intervention: Yoga, mindfulness practices, art therapy, and
music therapy
Arm group label:
Intervention - Arm 1
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.
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.
Criteria for 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.
Gender:
All
Minimum age:
65 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
Address:
City:
Cleveland
Zip:
44195
Country:
United States
Status:
Recruiting
Contact:
Last name:
Mariam AlHilli, MD
Investigator:
Last name:
Mariam AlHilli, MD
Email:
Principal Investigator
Start date:
July 23, 2024
Completion date:
February 10, 2025
Lead sponsor:
Agency:
Case Comprehensive Cancer Center
Agency class:
Other
Source:
Case Comprehensive Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06412510
