Recruiting
Phase 1
Phase 2

Prehabilitation with NACT

Sponsor:

Case Comprehensive Cancer Center

Code:

NCT06412510

Conditions

Ovarian Cancer

Epithelial Ovarian Cancer

Pancreatic Adenocarcinoma

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Interventions

Prehabilitation

Study Details

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

Study ID

NCT06412510

Start date

Sep 5, 2025

Status verified date

Mar, 2026

Completion date

Sep, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

22 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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

Primary outcome measure

  • Rate of adherence as calculated by the compliance percentage [ Time Frame: 6 weeks post intervention ]

Central Contacts and Locations

Central contacts

Mariam AlHilli, MD

216-644-0418alhillm@ccf.org

Locations

Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Recruiting

Cleveland, Ohio, United States, 44195

Principal Investigator:

Mariam AlHilli, MD

More Information

Sponsor

Case Comprehensive Cancer Center

Last update posted

Mar 18, 2026

Last verified

Mar, 2026

Keywords

  • Ovarian Cancer
  • Neoadjuvant chemotherapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Case Comprehensive Cancer Center on 2026-03-18.