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

NCT06412510RecruitingPHASE1, PHASE2INTERVENTIONAL

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.

Key Facts

Lead Sponsor

Case Comprehensive Cancer Center

Enrollment

Start Date

2025-09-05

Completion Date

2026-09-01

Study Type

INTERVENTIONAL

Official Title

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

Interventions

Prehabilitation

Conditions

Ovarian CancerEpithelial Ovarian CancerPancreatic Adenocarcinoma

Eligibility

Age Range

65 Years+

Sex

ALL

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.

Outcome Measures

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

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

Locations

Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center, Cleveland, United States