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

Prehabilitation for Elderly Patients With Advanced Epithelial Ovarian, Fallopian Tube, Primary Peritoneal Carcinoma and Pancreatic Cancer Undergoing Neoadjuvant Chemotherapy

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pancreatic Adenocarcinoma; Ovarian Cancer; Epithelial Ovarian Cancer
• Intervention / Treatment: Other: Prehabilitation

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Mariam AlHilli, MD; Phone Number: 216-644-0418; Email: alhillm@ccf.org

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
      • Contact: Mariam AlHilli, MD
      • Principal Investigator: Mariam AlHilli, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention - Arm 1; 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.	Other: Prehabilitation; 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
No Intervention: Control - Arm 2; Exercise: Standard of care. Level of activity will be reported and monitored at each visit through study coordinator assessment and patient interview. Nutrition: Participants will be referred to dietitian and will be seen for a baseline evaluation, as needed throughout treatment and post treatment. A full nutrition assessment will be performed, and malnutrition diagnosis will be documented. When no malnutrition is identified participants will be provided general nutrition counseling related to their cancer type, cancer treatment, and recommendations for symptom management as needed. Those participants identified to be malnourished to any degree will receive personalized medical nutrition therapy including nutrition interventions to improve caloric intake. Supportive care/Mind-body intervention: Per standard of care, participants will be offered support services from Taussig Cancer Institute program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 weeks post intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in effectiveness of prehabilitation as assessed by 1 Rep Max Isokinetic strength test	Rep Max Isokinetic Strength Test measured by BiostrengthTM Maximal Strength	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	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	Baseline, 6 weeks post intervention
Change in effectiveness of prehabilitation as assessed by 6-minute walk test	The 6-minute walk test is measured by the distance walked in 6 minutes	Baseline, 6 weeks post intervention
Change in effectiveness of prehabilitation as assessed by grip strength test	Grip strength test measured by handheld dynamometer	Baseline, 6 weeks post intervention
Change in effectiveness of prehabilitation as assessed by 30 second sit to stand test	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.	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.	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	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	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'	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'	Upto 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'	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'	Upto 6 weeks post intervention
Effectiveness of prehabilitation as assessed by Chemotherapy toxicity	Chemotherapy toxicity as measured by the standard CTCAE v5 grading system	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	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	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	Upto 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.	Upto 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.	Upto 6 weeks post surgery
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	Baseline
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	Upto 6 weeks post surgery

Collaborators and Investigators

• Sponsor: Case Comprehensive Cancer Center
• Investigators: Principal Investigator: Mariam AlHilli, MD, Cleveland Clinic Foundation, Case Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): February 10, 2025
• Study Completion (Estimated): February 10, 2025

Study Registration Dates

• First Submitted: May 8, 2024
• First Submitted That Met QC Criteria: May 13, 2024
• First Posted (Actual): May 14, 2024

Study Record Updates

• Last Update Posted (Actual): May 14, 2024
• Last Update Submitted That Met QC Criteria: May 13, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Ovarian Cancer; Neoadjuvant chemotherapy
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Female; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
• Other Study ID Numbers: CASE3824

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD that underlie results in publication will be shared with scientific journals during peer-review or at scientific/medical conferences/meetings. All IDP will be anonymized.
• IPD Sharing Time Frame: The data will become available during the course of the study and indefinitely thereafter.
• IPD Sharing Access Criteria: The data will be available as it pertains to journal publication to the scientific/medical community. This study has no intellectual property data that would require a CDA be in place.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No