## Protocol Section
### Identification Module
**NCT ID:** NCT06423963

**Brief Title:** Remote Exercise and Nutritional Prehabilitation for Pancreatic Cancer

**Official Title:** Remote Exercise and Nutritional Prehabilitation for Pancreatic Cancer

#### Organization Study ID Info
**ID:** MCC-23088
#### Organization
**Class:** OTHER
**Full Name:** H. Lee Moffitt Cancer Center and Research Institute
### Status Module
#### Completion Date
**Date:** 2026-02

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-21

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-16

**Overall Status:** RECRUITING

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

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-02-08

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-21
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-22
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** H. Lee Moffitt Cancer Center and Research Institute

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The purpose of the study is to examine the feasibility and acceptability of an exercise and nutrition "prehabilitation" program for patients preparing for pancreatic cancer resection (removal).

### Conditions Module

**Conditions:**

- Pancreatic Cancer

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 26

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Behavioral: Physical Activity

- Behavioral: Nutrition Counseling

**Label:** Physical activity, nutrition counseling and monitoring group (PA/N)

**Type:** EXPERIMENTAL

#### Arm Group 2

**Intervention Names:**

- Behavioral: Physical Activity

- Behavioral: Nutrition Counseling

- Behavioral: Resistance Training

**Label:** Physical activity, tele-resistance training, nutrition counseling and monitoring group (RT/N)

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Physical activity, nutrition counseling and monitoring group (PA/N)

- Physical activity, tele-resistance training, nutrition counseling and monitoring group (RT/N)

**Description:** Each participant will receive a Fitbit device with instruction and encouragement to self-monitor physical activity using step counts.

**Name:** Physical Activity

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- Physical activity, nutrition counseling and monitoring group (PA/N)

- Physical activity, tele-resistance training, nutrition counseling and monitoring group (RT/N)

**Description:** Participants will receive nutritional counseling with a registered dietician.

**Name:** Nutrition Counseling

**Type:** BEHAVIORAL

#### Intervention 3

**Arm Group Labels:**

- Physical activity, tele-resistance training, nutrition counseling and monitoring group (RT/N)

**Description:** Participants will engage in progressive, full-body resistance training based on American College of Sports Medicine (ACSM) guidelines.

**Name:** Resistance Training

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** The number of participants who complete T1 and T0 measures.

**Measure:** Feasibility and acceptability of PA/N and RT/N programs

**Time Frame:** Up to 16 weeks

#### Secondary Outcomes

**Description:** The number of participants who demonstrate improvements in exploratory outcome measures.

**Measure:** Examine exploratory outcomes and clinical characteristics

**Time Frame:** Up to 16 weeks

**Description:** Chi-Square testing will be used to determine if there's a significant difference in outcomes between the treatment group and a usual care comparison group.

**Measure:** Compare clinical and treatment outcomes

**Time Frame:** Up to 16 weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Age 18 years or older
* Biopsy-proven pancreatic ductal adenocarcinoma (PDAC), borderline resectable at diagnosis
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Undergoing neoadjuvant chemotherapy with treatment plan including chemoradiation therapy and surgical resection
* Ability to read and speak English

Exclusion Criteria:

* Regular engagement in RT (2x/week targeting all major muscle groups)
* Screen failure for exercise safety based on PAR-Q
* Underlying unstable cardiac or pulmonary disease or symptomatic cardiac disease
* Recent fracture or acute musculoskeletal injury that precludes ability to participate in RT
* Numeric pain rating scale greater than or equal to a 7 out of 10
* Myopathic or rheumatologic disease that impacts physical function

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** morgan.bean@moffitt.org

**Name:** Morgan Bean

**Phone:** 813-745-1786

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Tampa

**Contacts:**

***Contact 1:***

- **Email:** morgan.bean@moffitt.org

- **Name:** Morgan Bean

- **Phone:** 813-745-1786

- **Role:** CONTACT

***Contact 2:***

- **Name:** Nathan Parker, PhD

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 3:***

- **Name:** Pamela Hodul, MD

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 4:***

- **Name:** Sylvia Crowder, PhD

- **Role:** SUB_INVESTIGATOR

**Country:** United States

**Facility:** Moffitt Cancer Center

**State:** Florida

**Status:** RECRUITING

**Zip:** 33612

#### Overall Officials

**Official 1:**

**Affiliation:** Moffitt Cancer Center

**Name:** Nathan Parker, PhD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** Moffitt Cancer Center

**Name:** Pamela Hodul, MD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000004067

- Term: Digestive System Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000004701

- Term: Endocrine Gland Neoplasms

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000010182

- Term: Pancreatic Diseases

- ID: D000004700

- Term: Endocrine System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M13110

- Name: Pancreatic Neoplasms

- Relevance: HIGH

- As Found: Pancreatic Cancer

- ID: M8886

- Name: Gastrointestinal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7256

- Name: Digestive System Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7863

- Name: Endocrine Gland Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M13102

- Name: Pancreatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T4387

- Name: Pancreatic Cancer

- Relevance: HIGH

- As Found: Pancreatic Cancer

### Condition Browse Module - Meshes

- ID: D000010190

- Term: Pancreatic Neoplasms

### Misc Info Module

- Version Holder: 2024-05-31
