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

Phase 4

• Conditions: Esophageal Cancer; Pancreatic Cancer; Gastric Cancer
• Interventions: Combination Product: Nutritional Intervention; Behavioral: Physical Activity Intervention

• Registration Number: NCT03642093
• Lead Sponsor: Siobhan Trotter

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.

Detailed Description

Cancer patients often develop protein calorie malnutrition, inflammatory states, and loss of lean muscle mass, which can be best categorized as frailty. Frailty affects global health, the ability to carry out normal functions, and even the ability to tolerate targeted curative treatments such as surgery, chemotherapy, and radiation. The Investigators evaluate frailty, and design a study to evaluate the outcomes of the administration of multimodal preoperative prehabilitation programs on those frailty markers. Previous data provides support for interventions that include:

1. Improved protein rich nutrition with specific immunonutrition recommendations,

2. Treatment of maldigestion or pancreatic insufficiency in pancreatic, gastric, or esophageal cancer patients,

3. Brief, evidence-based activity interventions such as walking and inspiratory muscle training (IMT), and

4. Disease specific education

These interventions should improve frailty by maintaining or regaining weight, improved grip strength, and improved prealbumin. These markers indicate improvements in nutritional status, increased strength and ability to ambulate, and improved functional status in the preoperative period. Other outcomes that will be reported include fat-soluble vitamin levels, global health, and inflammation.

The preoperative period is the best time to facilitate patient engagement through self-care and proactive activity. Interventions must be easy to accomplish and structured so patients have accountability and both patients and clinicians have methods and tools for measuring progress. Most patients and family members are motivated at this time and understand the need to improve frailty and potentially improve global health.

Study Timeline

• Study First Submitted: 2018-06-20
• Study Start: 2018-08-01
• Study First Submitted QC: 2018-08-20
• Study First Posted: 2018-08-22
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-07
• Last Update Posted: 2018-09-11
• Primary Completion: 2018-12
• Study Completion: 2019-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Frail	Physical Activity Intervention	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
Frail	Nutritional Intervention	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
Not Frail	Physical Activity Intervention	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
Not Frail	Nutritional Intervention	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

Primary Outcome Measures

Name	Time	Method
Frailty Measurement	4 Weeks	Frailty will be measured using 3 criteria: weight loss, grip strength, and prealbumin serum level

Secondary Outcome Measures

Name	Time	Method
Vitamin levels	4 Weeks
Quality of Life (QoL) Assessment	4 Weeks	QoL will be assessed using Patient-Reported Outcome Measurement Information System (PROMIS) Global Health Questionnaire - PROMIS Scale v1.2 - Global Health

Trial Locations

Locations (1)

Ochsner Medical Center; 🇺🇸 New Orleans, Louisiana, United States