## Protocol Section
### Identification Module
**NCT ID:** NCT06430346

**Brief Title:** Exercise Prehabilitation for Locoregional Esophageal Cancer

**Official Title:** Exercise Prehabilitation for Locoregional Esophageal Cancer: A Pilot Study

#### Organization Study ID Info
**ID:** MCC-23121
#### Organization
**Class:** OTHER
**Full Name:** H. Lee Moffitt Cancer Center and Research Institute
### Status Module
#### Completion Date
**Date:** 2027-05

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-29

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2027-05

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-21
### 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 exercise "prehabilitation" for patients preparing for esophageal cancer resection (removal).

### Conditions Module

**Conditions:**

- Esophageal Cancer

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 20

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** In this trial participants will participate in an exercise program for 5 to 17 weeks, varying with treatment plans. Participants will receive resistance training equipment and participate in resistance training sessions twice per week (approximately 30-45 minutes per session). A Fitbit device will be provided to monitor step counts.

**Intervention Names:**

- Behavioral: Exercise

**Label:** Exercise prehabilitation

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Exercise prehabilitation

**Description:** Physical activity and resistance training

**Name:** Exercise

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

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

**Measure:** Retention

**Time Frame:** Up to 11 weeks

#### Secondary Outcomes

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

**Measure:** Exploratory outcomes and changes

**Time Frame:** Up to 17 weeks

**Description:** Chi-square testing will be used to determine if there's a difference in perioperative outcomes between groups.

**Measure:** Clinical and treatment outcomes

**Time Frame:** Up to 17 weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Biopsy-proven locoregional esophageal cancer (LEC)
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Treatment plan including neoadjuvant chemoradiation therapy and surgical resection
* Ability to read and speak English

Exclusion Criteria:

* Regular engagement in resistance training (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 resistance training safely
* Numeric pain rating scale of 7 or more 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:** Nathan.Parker@moffitt.org

**Name:** Nathan Parker, PhD

**Phone:** 813-745-6849

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Tampa

**Contacts:**

***Contact 1:***

- **Email:** Nathan.Parker@moffitt.org

- **Name:** Nathan Parker, PhD

- **Phone:** 813-745-0527

- **Role:** CONTACT

***Contact 2:***

- **Name:** Nathan Parker, PhD

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 3:***

- **Name:** Jose Pimiento, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** Moffitt Cancer Center

**State:** Florida

**Zip:** 33612

#### Overall Officials

**Official 1:**

**Affiliation:** Moffitt Cancer Center

**Name:** Nathan Parker, PhD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000005770

- Term: Gastrointestinal Neoplasms

- ID: D000004067

- Term: Digestive System Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000006258

- Term: Head and Neck Neoplasms

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000004935

- Term: Esophageal Diseases

- ID: D000005767

- Term: Gastrointestinal Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M8088

- Name: Esophageal Neoplasms

- Relevance: HIGH

- As Found: Esophageal Cancer

- ID: M8886

- Name: Gastrointestinal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7256

- Name: Digestive System Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M9348

- Name: Head and Neck 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: M8085

- Name: Esophageal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T2141

- Name: Esophageal Cancer

- Relevance: HIGH

- As Found: Esophageal Cancer

### Condition Browse Module - Meshes

- ID: D000004938

- Term: Esophageal Neoplasms

### Misc Info Module

- Version Holder: 2024-05-31
