## Protocol Section
### Identification Module
**NCT ID:** NCT06412510

**Brief Title:** Prehabilitation for EOC, Fallopian Tube, Primary Peritoneal Carcinoma and Pancreatic Cancer w/ NACT

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

#### Organization Study ID Info
**ID:** CASE3824
#### Organization
**Class:** OTHER
**Full Name:** Case Comprehensive Cancer Center
### Status Module
#### Completion Date
**Date:** 2025-02-10

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-14

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-13

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-02-10

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-14
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-08
**Study First Submit QC Date:** 2024-05-13
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Case Comprehensive Cancer Center

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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.

**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.

### Conditions Module

**Conditions:**

- Ovarian Cancer

- Epithelial Ovarian Cancer

- Pancreatic Adenocarcinoma

**Keywords:**

- Ovarian Cancer

- Neoadjuvant chemotherapy

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 30

**Type:** ESTIMATED

**Phases:**

- PHASE1

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Other: Prehabilitation

**Label:** Intervention - Arm 1

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 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.

**Label:** Control - Arm 2

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Intervention - Arm 1

**Description:** 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

**Name:** Prehabilitation

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

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

**Measure:** Rate of adherence as calculated by the compliance percentage

**Time Frame:** 6 weeks post intervention

#### Secondary Outcomes

**Description:** Rep Max Isokinetic Strength Test measured by BiostrengthTM Maximal Strength

**Measure:** Change in effectiveness of prehabilitation as assessed by 1 Rep Max Isokinetic strength test

**Time Frame:** Baseline, 6 weeks post intervention

**Description:** 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

**Measure:** 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

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

**Measure:** Change in effectiveness of prehabilitation as assessed by timed up and go test

**Time Frame:** Baseline, 6 weeks post intervention

**Description:** The 6-minute walk test is measured by the distance walked in 6 minutes

**Measure:** Change in effectiveness of prehabilitation as assessed by 6-minute walk test

**Time Frame:** Baseline, 6 weeks post intervention

**Description:** Grip strength test measured by handheld dynamometer

**Measure:** Change in effectiveness of prehabilitation as assessed by grip strength test

**Time Frame:** Baseline, 6 weeks post intervention

**Description:** 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.

**Measure:** Change in effectiveness of prehabilitation as assessed by 30 second sit to stand test

**Time Frame:** Baseline, 6 weeks post intervention

**Description:** 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.

**Measure:** Change in measure of balance as assessed by unipedal stance test

**Time Frame:** Baseline, 6 weeks post intervention

**Description:** Body composition measured using contrast-enhanced CT scan

**Measure:** Effectiveness of prehabilitation as assessed by measuring the change in body mass composition

**Time Frame:** Baseline, 6 weeks post-intervention

**Description:** 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

**Measure:** 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

**Description:** 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'

**Measure:** Quality of life as assessed by FACT-G7 (Functional Assessment of Cancer Therapy)

**Time Frame:** At baseline

**Description:** 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'

**Measure:** Quality of life as assessed by FACT-G7 (Functional Assessment of Cancer Therapy)

**Time Frame:** Upto 6 weeks post intervention

**Description:** 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'

**Measure:** Quality of life as assessed by FACT-O

**Time Frame:** At baseline

**Description:** 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'

**Measure:** Quality of life as assessed by FACT-O

**Time Frame:** Upto 6 weeks post intervention

**Description:** Chemotherapy toxicity as measured by the standard CTCAE v5 grading system

**Measure:** Effectiveness of prehabilitation as assessed by Chemotherapy toxicity

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

**Description:** Chemotherapy toxicity as measured by the standard CTCAE v5 grading system

**Measure:** Effectiveness of prehabilitation as assessed by Chemotherapy toxicity

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

**Description:** Chemotherapy toxicity as measured by the standard CTCAE v5 grading system

**Measure:** Effectiveness of prehabilitation as assessed by Chemotherapy toxicity

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

**Description:** Chemotherapy toxicity as measured by the standard CTCAE v5 grading system

**Measure:** Effectiveness of prehabilitation as assessed by Chemotherapy toxicity

**Time Frame:** Upto 6 weeks post intervention

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

**Measure:** Effectiveness of prehabilitation as assessed by participant acceptability of intervention survey using IAM(Intervention appropriateness measure)

**Time Frame:** Upto 6 weeks post intervention

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

**Measure:** Effectiveness of prehabilitation as assessed by participant acceptability of intervention survey using FIM(Feasibility of intervention measure)

**Time Frame:** Upto 6 weeks post surgery

**Description:** 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

**Measure:** Effectiveness of prehabilitation as assessed by participant acceptability scale

**Time Frame:** Baseline

**Description:** 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

**Measure:** Effectiveness of prehabilitation as assessed by participant acceptability scale

**Time Frame:** Upto 6 weeks post surgery

### Eligibility Module

**Eligibility Criteria:** 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.

**Minimum Age:** 65 Years

**Sex:** ALL

**Standard Ages:**

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** alhillm@ccf.org

**Name:** Mariam AlHilli, MD

**Phone:** 216-644-0418

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Cleveland

**Contacts:**

***Contact 1:***

- **Name:** Mariam AlHilli, MD

- **Role:** CONTACT

***Contact 2:***

- **Name:** Mariam AlHilli, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

**State:** Ohio

**Zip:** 44195

#### Overall Officials

**Official 1:**

**Affiliation:** Cleveland Clinic Foundation, Case Comprehensive Cancer Center

**Name:** Mariam AlHilli, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**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.

**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.

**Info Types:**

- STUDY_PROTOCOL

- SAP

- ICF

- CSR

- ANALYTIC_CODE

**IPD Sharing:** YES

**Time Frame:** The data will become available during the course of the study and indefinitely thereafter.

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000002277

- Term: Carcinoma

- ID: D000009375

- Term: Neoplasms, Glandular and Epithelial

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000009369

- Term: Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000004701

- Term: Endocrine Gland Neoplasms

- ID: D000004700

- Term: Endocrine System Diseases

- ID: D000010049

- Term: Ovarian Diseases

- ID: D000000291

- Term: Adnexal Diseases

- ID: D000005831

- Term: Genital Diseases, Female

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000005833

- Term: Genital Neoplasms, Female

- ID: D000014565

- Term: Urogenital Neoplasms

- ID: D000091662

- Term: Genital Diseases

- ID: D000006058

- Term: Gonadal Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: All

- Name: All Conditions

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M5534

- Name: Carcinoma

- Relevance: LOW

- As Found: Unknown

- ID: M12974

- Name: Ovarian Neoplasms

- Relevance: HIGH

- As Found: Ovarian Cancer

- ID: M1704

- Name: Carcinoma, Ovarian Epithelial

- Relevance: HIGH

- As Found: Ovarian Cancer

- ID: M13110

- Name: Pancreatic Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M3585

- Name: Adenocarcinoma

- Relevance: LOW

- As Found: Unknown

- ID: M12320

- Name: Neoplasms, Glandular and Epithelial

- Relevance: LOW

- As Found: Unknown

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: M7863

- Name: Endocrine Gland Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12972

- Name: Ovarian Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M3643

- Name: Adnexal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8943

- Name: Genital Diseases, Female

- Relevance: LOW

- As Found: Unknown

- ID: M2876

- Name: Genital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8945

- Name: Genital Neoplasms, Female

- Relevance: LOW

- As Found: Unknown

- ID: M17315

- Name: Urogenital Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M9163

- Name: Gonadal Disorders

- Relevance: LOW

- As Found: Unknown

- ID: T4352

- Name: Ovarian Cancer

- Relevance: HIGH

- As Found: Ovarian Cancer

- ID: T4354

- Name: Ovarian Epithelial Cancer

- Relevance: HIGH

- As Found: Ovarian Cancer

- ID: T4387

- Name: Pancreatic Cancer

- Relevance: HIGH

- As Found: Pancreatic Cancer

### Condition Browse Module - Meshes

- ID: D000010051

- Term: Ovarian Neoplasms

- ID: D000077216

- Term: Carcinoma, Ovarian Epithelial

### Misc Info Module

- Version Holder: 2024-05-31
