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

NCT06412510 | Recruiting Phase 1 DMC

• 1 other identifier: CASE3824
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Cancer; Epithelial Ovarian Cancer; Pancreatic Adenocarcinoma

Keywords

Ovarian Cancer; Neoadjuvant chemotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (20)

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

  Baseline, 6 weeks post intervention

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

  Baseline, 6 weeks post intervention

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

  Baseline, 6 weeks post intervention

• Change in effectiveness of prehabilitation as assessed by grip strength test

  Baseline, 6 weeks post intervention

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

  Baseline, 6 weeks post intervention

Study Arms (2)

Intervention - Arm 1

EXPERIMENTAL

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

Control - Arm 2

NO INTERVENTION

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.

Interventions

Prehabilitation OTHER

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

Intervention - Arm 1

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms; Carcinoma, Ovarian Epithelial

Interventions

Preoperative Exercise

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Perioperative Care; Patient Care; Therapeutics; Surgical Procedures, Operative; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Mariam AlHilli, MD

  Cleveland Clinic Foundation, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mariam AlHilli, MD

CONTACT

216-644-0418; alhillm@ccf.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2024
• First Posted: May 14, 2024
• Study Start: September 5, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data will become available during the course of the study and indefinitely thereafter.
• 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.

Locations

US (1)