Prehabilitation for EOC, Fallopian Tube, Primary Peritoneal Carcinoma and Pancreatic Cancer w/ NACT
- Conditions
- Pancreatic AdenocarcinomaOvarian CancerEpithelial Ovarian Cancer
- Interventions
- Other: Prehabilitation
- Registration Number
- NCT06412510
- Lead 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 22
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention - Arm 1 Prehabilitation Exercise Intervention: Participants will be referred to Langston Hughes Community Center and work with exercise physiologists who will utilize our SmartGym ecosystem in providing exercise assessments, prescriptions, and training. Nitrition Intervention: Participants in the intervention group will be provided with 1-2 bottles of high protein oral nutritional supplements daily (ONS) to ensure that protein needs are met daily. There will be two options of ONS to choose from: one option a high calorie, high protein supplement, and the other option a low fat/low sugar, high protein supplement. Supportive care/Mind-body intervention: Participants will have access to Taussig Cancer Institute Patient Support services that are offered for free.
- Primary Outcome Measures
Name Time Method Rate of adherence as calculated by the compliance percentage 6 weeks post intervention Compliance will be defined as completion of at least 2 exercise sessions per week (75%) for the duration of the study.
- Secondary Outcome Measures
Name Time Method Change in effectiveness of prehabilitation as assessed by timed up and go test Baseline, 6 weeks post intervention Timed up and go test is one unit of time to measure how fast patients can move
Effectiveness of prehabilitation as assessed by the change in nutritional status Baseline, Cycle 2 day 1, cycle 3 day 1, cycle 4 day 1(each cycle is 21 days) and 6 weeks post-intervention Assessed for the presence of malnutrition per the Cleveland Clinic organization's standard of care based on American Society for Parenteral and Enteral Nutrition (ASPEN) and the Academy of Nutrition and Dietetics (AND) (ASPEN/AND) guidelines, and by assessing changes in the degree of malnutrition throughout the study period
Change in effectiveness of prehabilitation as assessed by Grade Exercise Test Grade Exercise Test measured by Grade Exercise Test. Baseline, 6 weeks post intervention At baseline, and within the immediate post-exercise recovery, rating of perceived exertion (RPE; Borg scale, 6-20) will be assessed. Peak exercise exhaustion was verified if two or more of the following criteria were met: 1)96 HR within 10 bpm of age-predicted maximum HR (220-age), 2) RPE \> 17, and/or 3) a plateau in HR (\<3 bpm change over the last two intensity stages).
VO2 max will be calculated by ACSM's Treadmill Walking Equation:
VO2 \[ml/kg/min\] = (0.1 x speed) + (1.8 x Speed x Grade) 3.5 ml/kg/minEffectiveness of prehabilitation as assessed by measuring the change in body mass composition Baseline, 6 weeks post-intervention Body composition measured using contrast-enhanced CT scan
Quality of life as assessed by FACT-G7 (Functional Assessment of Cancer Therapy) Up to 6 weeks post intervention Functional Assessment of Cancer Therapy(FACT-G7) to assess the illness is measured on a scale from 0 to 4, where 0 is 'not at all' and 4 is 'very much'
Quality of life as assessed by FACT-O Up to 6 weeks post intervention FACT-O to assess the illness is measured on a scale from 0 to 4, where 0 is 'not at all' and 4 is 'very much'
Effectiveness of prehabilitation as assessed by Chemotherapy toxicity Up to 6 weeks post intervention Chemotherapy toxicity as measured by the standard CTCAE v5 grading system
Change in effectiveness of prehabilitation as assessed by 1 Rep Max Isokinetic strength test Baseline, 6 weeks post intervention Rep Max Isokinetic Strength Test measured by BiostrengthTM Maximal Strength
Change in effectiveness of prehabilitation as assessed by grip strength test Baseline, 6 weeks post intervention Grip strength test measured by handheld dynamometer
Change in effectiveness of prehabilitation as assessed by 30 second sit to stand test Baseline, 6 weeks post intervention The number of times a patient can rise to a standing position from a seated position without the use of their upper extremities is counted in a thirty second period.
Change in measure of balance as assessed by unipedal stance test Baseline, 6 weeks post intervention This is a measure of balance and is assessed by asking the participant to stand on one foot (of their choice) with the lifted foot remaining close to their opposite ankle, first with eyes open and then with eyes closed.The amount of time a participant can stand on one foot is recorded.
Effectiveness of prehabilitation as assessed by participant acceptability of intervention survey using FIM(Feasibility of intervention measure) Up to 6 weeks post intervention FIM is measured on a scale of 1 to 5, where 1 is completely disagree and 5 is completely agree.
Effectiveness of prehabilitation as assessed by participant acceptability of intervention survey using IAM(Intervention appropriateness measure) Up to 6 weeks post intervention IAM is measured on a scale of 1 to 5, where 1 is completely disagree and 5 is completely agree.
Effectiveness of prehabilitation as assessed by participant acceptability scale Up to 6 weeks post intervention Participant acceptability of anxiety and depression screening as measured by Hospital anxiety and depression scale(HADS) scoring from 0-21 where 0-7 is normal;8-10 is borderline abnormal; 11-21 is abnormal
Trial Locations
- Locations (1)
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
🇺🇸Cleveland, Ohio, United States