Clinical trial NCT06412510: Prehabilitation for EOC, Fallopian Tube, Primary Peritoneal Carcinoma and Pancreatic Cancer w/ NACT
Official title: Prehabilitation for Elderly Patients With Advanced Epithelial Ovarian, Fallopian Tube, Primary Peritoneal Carcinoma and Pancreatic Cancer Undergoing Neoadjuvant Chemotherapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Ovarian Cancer
Epithelial Ovarian Cancer
Pancreatic Adenocarcinoma
Keywords: Ovarian Cancer
Neoadjuvant chemotherapy
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2024-05-14
Enrollment: 22
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

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.

Primary outcomes:
measure: Rate of adherence as calculated by the compliance percentage
timeFrame: 6 weeks post intervention
Secondary outcomes:
measure: Change in effectiveness of prehabilitation as assessed by 1 Rep Max Isokinetic strength test
timeFrame: Baseline, 6 weeks post intervention
measure: Change in effectiveness of prehabilitation as assessed by Grade Exercise Test Grade Exercise Test measured by Grade Exercise Test.
timeFrame: Baseline, 6 weeks post intervention
measure: Change in effectiveness of prehabilitation as assessed by timed up and go test
timeFrame: Baseline, 6 weeks post intervention
measure: Change in effectiveness of prehabilitation as assessed by grip strength test
timeFrame: Baseline, 6 weeks post intervention
measure: Change in effectiveness of prehabilitation as assessed by 30 second sit to stand test
timeFrame: Baseline, 6 weeks post intervention
measure: Change in measure of balance as assessed by unipedal stance test
timeFrame: Baseline, 6 weeks post intervention
measure: Effectiveness of prehabilitation as assessed by measuring the change in body mass composition
timeFrame: Baseline, 6 weeks post-intervention
measure: Effectiveness of prehabilitation as assessed by the change in nutritional status
timeFrame: Baseline, Cycle 2 day 1, cycle 3 day 1, cycle 4 day 1(each cycle is 21 days) and 6 weeks post-intervention
measure: Quality of life as assessed by FACT-G7 (Functional Assessment of Cancer Therapy)
timeFrame: At baseline
measure: Quality of life as assessed by FACT-G7 (Functional Assessment of Cancer Therapy)
timeFrame: Up to 6 weeks post intervention
measure: Quality of life as assessed by FACT-O
timeFrame: At baseline
measure: Quality of life as assessed by FACT-O
timeFrame: Up to 6 weeks post intervention
measure: Effectiveness of prehabilitation as assessed by Chemotherapy toxicity
timeFrame: At cycle 2, day 1(each cycle is 21 days)
measure: Effectiveness of prehabilitation as assessed by Chemotherapy toxicity
timeFrame: At cycle 3, day 1(each cycle is 21 days)
measure: Effectiveness of prehabilitation as assessed by Chemotherapy toxicity
timeFrame: At cycle 4, day 1(each cycle is 21 days)
measure: Effectiveness of prehabilitation as assessed by Chemotherapy toxicity
timeFrame: Up to 6 weeks post intervention
measure: Effectiveness of prehabilitation as assessed by participant acceptability of intervention survey using IAM(Intervention appropriateness measure)
timeFrame: Up to 6 weeks post intervention
measure: Effectiveness of prehabilitation as assessed by participant acceptability of intervention survey using FIM(Feasibility of intervention measure)
timeFrame: Up to 6 weeks post intervention
measure: Effectiveness of prehabilitation as assessed by participant acceptability scale
timeFrame: Baseline
measure: Effectiveness of prehabilitation as assessed by participant acceptability scale
timeFrame: Up to 6 weeks post intervention
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Cleveland Clinic Foundation, Case Comprehensive Cancer Center
name: Mariam AlHilli, MD
role: PRINCIPAL_INVESTIGATOR
References: