CClinicalTrials.gg
Sign In
Status unknownNCT03642093HOPEUpdated Sep 11, 2018

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

A Phase 4 interventional study of Nutritional Intervention and Physical Activity Intervention in Pancreatic Cancer, Esophageal Cancer and Gastric Cancer, sponsored by Siobhan Trotter. Status unknown at 1 site in United States. Open to participants aged 25 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-09-11.

Sponsored by Siobhan Trotter · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2018), so the status shown — last known as Enrolling by invitation — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
25 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Pancreatic Cancer
  • Esophageal Cancer
  • Gastric Cancer

Keywords

  • Frailty
  • Prehabilitation
03

In context

Lead sponsor

This is the only study on the registry with Siobhan Trotter as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Frail

    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

  • Active comparator
    Not Frail

    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

  • Combination productNutritional Intervention

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

    Also known as: Immunonutrition

  • BehavioralPhysical Activity Intervention

    Walking and Inspiratory Muscle Training

06

What researchers measure

Primary outcomes

  1. Frailty Measurement

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

    Time frame: 4 Weeks

Secondary outcomes

  1. Vitamin levels

    Time frame: 4 Weeks

  2. Quality of Life (QoL) Assessment

    QoL will be assessed using Patient-Reported Outcome Measurement Information System (PROMIS) Global Health Questionnaire - PROMIS Scale v1.2 - Global Health

    Time frame: 4 Weeks

07

Study locations

1 site
  • Ochsner Medical Center
    New Orleans, Louisiana 70471, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 11, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03642093
Lead sponsor
Siobhan Trotter
Responsible party
Siobhan Trotter (Nurse Practitioner, Preoperative Optimization Program, Surgical Oncology and General Surgery, Ochsner Health System) — Sponsor-investigator
First posted
Aug 22, 2018
Start date
Aug 1, 2018
Primary completion
Dec 2018 (estimated)
Completion
May 2019 (estimated)
Last update
Sep 11, 2018

Study contacts

Siobhan M Trotter, DNP
principal investigator · Ochsner Health System

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion