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

Phase 2RecruitingNCT06412510

Case Comprehensive Cancer Center22 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Ovarian Cancer Epithelial Ovarian Cancer Pancreatic Adenocarcinoma

Interventions

PrehabilitationOTHER

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

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

RECRUITING

Outcomes

Primary Outcomes

Rate of adherence as calculated by the compliance percentage

Compliance will be defined as completion of at least 2 exercise sessions per week (75%) for the duration of the study.

Time frame: 6 weeks post intervention

Secondary Outcomes

Change in effectiveness of prehabilitation as assessed by 1 Rep Max Isokinetic strength test

Rep Max Isokinetic Strength Test measured by BiostrengthTM Maximal Strength

Time frame: Baseline, 6 weeks post intervention

Change in effectiveness of prehabilitation as assessed by Grade Exercise Test Grade Exercise Test measured by Grade Exercise Test.

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/min

Time frame: Baseline, 6 weeks post intervention

Change in effectiveness of prehabilitation as assessed by timed up and go test

Timed up and go test is one unit of time to measure how fast patients can move

Time frame: Baseline, 6 weeks post intervention

Change in effectiveness of prehabilitation as assessed by grip strength test

Grip strength test measured by handheld dynamometer

Time frame: Baseline, 6 weeks post intervention

Change in effectiveness of prehabilitation as assessed by 30 second sit to stand test

Central Contacts

Mariam AlHilli, MD

CONTACT

216-644-0418 alhillm@ccf.org

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

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.

Time frame: Baseline, 6 weeks post intervention

Change in measure of balance as assessed by unipedal stance test

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.

Time frame: Baseline, 6 weeks post intervention

Effectiveness of prehabilitation as assessed by measuring the change in body mass composition

Body composition measured using contrast-enhanced CT scan

Time frame: Baseline, 6 weeks post-intervention

Effectiveness of prehabilitation as assessed by the change in nutritional status

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

Time frame: Baseline, Cycle 2 day 1, cycle 3 day 1, cycle 4 day 1(each cycle is 21 days) and 6 weeks post-intervention

Quality of life as assessed by FACT-G7 (Functional Assessment of Cancer Therapy)

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'

Time frame: At baseline

Quality of life as assessed by FACT-G7 (Functional Assessment of Cancer Therapy)

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'

Time frame: Up to 6 weeks post intervention

Quality of life as assessed by FACT-O

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'

Time frame: At baseline

Quality of life as assessed by FACT-O

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'

Time frame: Up to 6 weeks post intervention

Effectiveness of prehabilitation as assessed by Chemotherapy toxicity

Chemotherapy toxicity as measured by the standard CTCAE v5 grading system

Time frame: At cycle 2, day 1(each cycle is 21 days)

Effectiveness of prehabilitation as assessed by Chemotherapy toxicity

Chemotherapy toxicity as measured by the standard CTCAE v5 grading system

Time frame: At cycle 3, day 1(each cycle is 21 days)

Effectiveness of prehabilitation as assessed by Chemotherapy toxicity

Chemotherapy toxicity as measured by the standard CTCAE v5 grading system

Time frame: At cycle 4, day 1(each cycle is 21 days)

Effectiveness of prehabilitation as assessed by Chemotherapy toxicity

Chemotherapy toxicity as measured by the standard CTCAE v5 grading system

Time frame: Up to 6 weeks post intervention

Effectiveness of prehabilitation as assessed by participant acceptability of intervention survey using IAM(Intervention appropriateness measure)

IAM is measured on a scale of 1 to 5, where 1 is completely disagree and 5 is completely agree.

Time frame: Up to 6 weeks post intervention

Effectiveness of prehabilitation as assessed by participant acceptability of intervention survey using FIM(Feasibility of intervention measure)

FIM is measured on a scale of 1 to 5, where 1 is completely disagree and 5 is completely agree.

Time frame: Up to 6 weeks post intervention

Effectiveness of prehabilitation as assessed by participant acceptability scale

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

Time frame: Baseline

Effectiveness of prehabilitation as assessed by participant acceptability scale

Time frame: Up to 6 weeks post intervention