HOPE - A Study to Evaluate the Effect of a Prehabilitation Program on GI Cancer Patients Planning to Undergo Surgery

NCT03642093 | Unknown Phase 4 FDA Drug

• 1 other identifier: HOPE Study 2018.045
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

A one-group prospective cohort study design with measures collected pre- and post-intervention. The primary goal of this study is to evaluate the effect of a multimodal prehabilitation preoperative program on changes in frailty in upper gastrointestinal surgical oncology patients.

Conditions

Pancreatic Cancer; Esophageal Cancer; Gastric Cancer

Keywords

Frailty; Prehabilitation

Outcome Measures

Primary Outcomes (1)

• Frailty Measurement

  Frailty will be measured using 3 criteria: weight loss, grip strength, and prealbumin serum level

  4 Weeks

Secondary Outcomes (2)

• Vitamin levels

  4 Weeks

• Quality of Life (QoL) Assessment

  4 Weeks

Study Arms (2)

Frail

EXPERIMENTAL

Subjects assessed and determined to be Frail and meet trial eligibility criteria will be enrolled on Frail Arm and begin a 4 Week program consisting of Nutritional Interventions and Physical Activity Interventions

Combination Product: Nutritional Intervention; Behavioral: Physical Activity Intervention

Not Frail

ACTIVE COMPARATOR

Subjects assessed and determined to be Not Frail and meet trial eligibility criteria will be enrolled on Not Frail Arm and begin a 4 Week program consisting of Nutritional Interventions and Physical Activity Interventions

Combination Product: Nutritional Intervention; Behavioral: Physical Activity Intervention

Interventions

Nutritional Intervention COMBINATION_PRODUCT

Nutritional Supplementation for all subjects and Pancreatic Enzyme Replacement Therapy only for subjects with Exocrine Pancreatic Insufficiency

Also known as: Immunonutrition

Frail; Not Frail

Physical Activity Intervention BEHAVIORAL

Walking and Inspiratory Muscle Training

Frail; Not Frail

Eligibility Criteria

• Age: 25 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients must be patients of Ochsner being seen at the Ochsner Medical Center (OMC).
• All patients must be 25 to 80 years of age.
• All patients must have a diagnosis of cancer.
• \> 10 pound unintentional weight loss within 1 year
• Ability to perform grip strength test and Timed Up and Go (TUG) test
• Willingness to participate in the study, document compliance, and attend clinical appointments
• All patients must be undergoing one of the following major elective surgical oncologic resections with curative intent:
• Pancreaticoduodenectomy for pancreatic cancer
• Distal pancreatectomy / splenectomy for pancreatic cancer
• Esophageal robotic assisted laparoscopic thoracoscopic esophagectomy for esophageal cancer
• Laparoscopic or open, partial or total gastrectomy for gastric cancer

You may not qualify if:

• All patients not undergoing oncologic or major resections.
• All patients unwilling or unable to answer questionnaires or accept help to answer electronic or paper questionnaires.
• All patients that are unable to participate in an activity program.
• All patients unable to wear an electronic activity monitoring device.
• All patients not wanting to follow a specific nutritional and breathing intervention.
• All patients that are not able or wishing to consent.

Sponsors & Collaborators

• Siobhan Trotter: lead

Study Sites (1)

Ochsner Medical Center

New Orleans, Louisiana, 70471, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Esophageal Neoplasms; Stomach Neoplasms; Frailty

Interventions

Immunonutrition Diet

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Gastrointestinal Neoplasms; Head and Neck Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Stomach Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Siobhan M Trotter, DNP

  Ochsner Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Nurse Practitioner, Preoperative Optimization Program, Surgical Oncology and General Surgery

Study Record Dates

• First Submitted: June 20, 2018
• First Posted: August 22, 2018
• Study Start: August 1, 2018
• Primary Completion: December 1, 2018
• Study Completion: May 1, 2019
• Last Updated: September 11, 2018

Record last verified: 2018-09

Locations

US (1)