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NCT Number: NCT06412510

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

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.

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Key information

Conditions

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

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location status: Recruiting

Location contact

Mariam AlHilli, MD

CONTACT

Mariam AlHilli, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Rate of adherence as calculated by the compliance percentage

    Time frame: 6 weeks post intervention

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

Secondary outcomes

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

    Time frame: Baseline, 6 weeks post intervention

    Rep Max Isokinetic Strength Test measured by BiostrengthTM Maximal Strength

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

    Time frame: Baseline, 6 weeks post intervention

    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

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

    Time frame: Baseline, 6 weeks post intervention

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

  4. Change in effectiveness of prehabilitation as assessed by grip strength test

    Time frame: Baseline, 6 weeks post intervention

    Grip strength test measured by handheld dynamometer

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

    Time frame: Baseline, 6 weeks post intervention

    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.

  6. Change in measure of balance as assessed by unipedal stance test

    Time frame: Baseline, 6 weeks post intervention

    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.

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

    Time frame: Baseline, 6 weeks post-intervention

    Body composition measured using contrast-enhanced CT scan

  8. Effectiveness of prehabilitation as assessed by the change in nutritional status

    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

    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

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

    Time frame: At baseline

    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'

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

    Time frame: Up to 6 weeks post intervention

    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'

  11. Quality of life as assessed by FACT-O

    Time frame: At baseline

    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'

  12. Quality of life as assessed by FACT-O

    Time frame: Up to 6 weeks post intervention

    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'

  13. Effectiveness of prehabilitation as assessed by Chemotherapy toxicity

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

    Chemotherapy toxicity as measured by the standard CTCAE v5 grading system

  14. Effectiveness of prehabilitation as assessed by Chemotherapy toxicity

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

    Chemotherapy toxicity as measured by the standard CTCAE v5 grading system

  15. Effectiveness of prehabilitation as assessed by Chemotherapy toxicity

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

    Chemotherapy toxicity as measured by the standard CTCAE v5 grading system

  16. Effectiveness of prehabilitation as assessed by Chemotherapy toxicity

    Time frame: Up to 6 weeks post intervention

    Chemotherapy toxicity as measured by the standard CTCAE v5 grading system

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

    Time frame: Up to 6 weeks post intervention

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

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

    Time frame: Up to 6 weeks post intervention

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

  19. Effectiveness of prehabilitation as assessed by participant acceptability scale

    Time frame: Baseline

    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

  20. Effectiveness of prehabilitation as assessed by participant acceptability scale

    Time frame: Up to 6 weeks post intervention

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Mariam AlHilli, MD

CONTACT

[email protected]

216-644-0418

Sponsors and collaborators

Lead sponsor

Case Comprehensive Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 14, 2024
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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