Octreotide Treatment to Improve Nutritional Recovery After Surgery for Patients with Esophageal or Gastric Cancer (OTIS)

October 29, 2024 updated by: Fredrik Klevebro

Octreotide Treatment to Improve Nutritional Recovery After Surgery for Patients with Esophageal or Gastric Cancer, a Prospective Randomized Open Label Phase II Study - OTIS

The aim of the study is to clarify whether octreotide therapy can reduce undesired postoperative weight loss, increase health-related quality of life and improve the appetite after surgery for esophageal or gastric cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Dietary complications are the biggest problem for patients before, during and after surgical treatment. Improved multimodal therapy and centralization of treatment to highly specialized centers have led to an increase in the number of patients surviving with chronic negative effects of esophageal surgery. The scientific state of knowledge about HRQOL and the symptoms of long-term survival of esophageal cancer is limited.

Patient-reported outcome measures (PRUs) are results reported by the patient himself, e.g. HRQOL, remaining symptoms, satisfaction with health care and other problems in daily life. These results have rarely been of importance before but are now increasingly crucial in the evaluation of treatment. It is no longer just about survival for patients with cancer of the esophagus. The aim of the study is to clarify whether octreotide therapy can reduce undesired postoperative weight loss, increase health-related quality of life and improve the appetite after surgery for esophageal or gastric cancer.

Our hypothesis is that intramuscularly administered octreotide can decrease weight loss after gastrectomy or esophagectomy due to cancer and that it may improve postoperative health related quality of life. This study aims to investigate if postoperative eating problems can be reduced by treatment with octreotide in this patient group.

In the first part of the study: Sub study 1, safety, tolerability and feasibility of octreotide treatment will be investigated. Twenty patients diagnosed with esophageal or gastric cancer will receive three monthly injections of 10 mg of Sandostatin LAR depot. Patients will be followed up at 1, 2, 3 and 6 months for monitoring of safety blood parameters, changes in weight, health-related quality of life and adverse events.

In the second part of the study: Sub study 2, efficacy of treatment with octreotide will be studied. 152 patients diagnosed with esophageal or gastric cancer will be randomized 1:1 to post-surgical treatment with octreotide or no treatment. Patients in the active arm will receive three monthly injections of 10 mg of Sandostatin LAR depot. All patients will be followed up at 1, 2, 3 and 6 months in the same manner as in Sub study 1. In this study part gastrointestinal satiety hormones and nutritional evaluation associated quality of life will be studied in addition to body weight, body composition and health-related quality of life.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden
        • Karolinska University Hospital, Huddinge

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Pathologic anatomic analysis (PAD) confirmed esophageal or gastric cancer
  2. Gastrectomy or esophagectomy with curative intent
  3. ≥18 years of age
  4. Signed informed consent
  5. Able to comply with the procedures of the study protocol, in the opinion of the investigator
  6. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, only after A. leaving a negative result on a highly sensitive pregnancy test, B. are using a highly effective method of contraception during treatment, and C. throughout the study.

Exclusion Criteria:

  1. Non-radical operation (defined by macroscopic assessment) or metastatic disease diagnosed at the time of surgery
  2. Complications leading to restrictions in postoperative oral intake
  3. Advanced comorbidity with ASA score III or more
  4. Bradycardia (defined as resting heart rate of under 60 beats per minute)
  5. Chronic obstructive pulmonary disease
  6. Chronic liver disease
  7. Insulinoma
  8. Kidney failure
  9. Concomitant medication with: cyclosporine, cimetidine, bromocriptine, quinidine, or terfenadine
  10. Known or suspected allergy to octreotide
  11. Mental inability, reluctance or language difficulties that result in difficulty understanding the meaning of study participation
  12. Pregnant or nursing female
  13. Participation or recent participation in a clinical study with an investigational product (within the last 3 months). Previous participation in this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Standard treatment
Experimental: Octreotide
3 monthly intramuscular injections of 10 mg Octreotide
Drug: Octreotide Injection
10 mg Sandostatin LAR intramuscular injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight change in percent (%)
Time Frame: From baseline before surgery, at 1, 2, 3, and 6 months
Weight loss in percent (%) from baseline weight before surgery, measured at 1, 2, 3, and 6 months after surgery
From baseline before surgery, at 1, 2, 3, and 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in gastrointestinal satiety hormone levels
Time Frame: Baseline, 7 days post-surgery and at 1, 2, 3 and 6 months
Measurement of S-GLP-1, S-PYY, S-Ghrelin and S-GIP (prior to octreotide administration), measured at baseline, 7 days post-surgery and after 1, 2, 3 and 6 months.
Baseline, 7 days post-surgery and at 1, 2, 3 and 6 months
Changes in body composition
Time Frame: Baseline, 1, 2, 3, and 6 months
Body composition measured in percent (%) body fat (continuously)
Baseline, 1, 2, 3, and 6 months
Changes in nutritional status - PG-SGA
Time Frame: Baseline, 1, 2, 3, and 6 months
Nutritional status measured with the questionnaire PG-SGA
Baseline, 1, 2, 3, and 6 months
Changes in nutritional status - EORTC CAX24
Time Frame: Baseline, 1, 2, 3, and 6 months
Nutritional status measured with the questionnaire EORTC CAX24
Baseline, 1, 2, 3, and 6 months
Health-related Quality of Life - EORTC QLQ-C30
Time Frame: Baseline, 1, 2, 3 and 6 months
Health-related Quality of Life (HRQOL) measured using EORTC QLQ-C30 at baseline and at 1, 2, 3 and 6 months after randomization
Baseline, 1, 2, 3 and 6 months
Health-related Quality of Life - QLQ-OG25
Time Frame: Baseline, 1, 2, 3 and 6 months
Health-related Quality of Life (HRQOL) measured using QLQ-OG25 at baseline and at 1, 2, 3 and 6 months after randomization
Baseline, 1, 2, 3 and 6 months
Percentage (of subjects) in need of enteral nutrition
Time Frame: Baseline, 1, 2, 3 and 6 months
Percentage (of subjects) in need of enteral nutrition with a jejunostomy feeding catheter or nasogastric tube
Baseline, 1, 2, 3 and 6 months
Number and type of Adverse Events
Time Frame: From 7 days post-surgery and at 1, 2, 3 and 6 months (continuously)
Number and type of Adverse Events, including known AEs of Sandostatin LAR depot
From 7 days post-surgery and at 1, 2, 3 and 6 months (continuously)
Number of patients completing treatment
Time Frame: From first treatment at 7 days post-surgery to last treatment at 2 months
Number of patients completing treatment
From first treatment at 7 days post-surgery to last treatment at 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fredrik Klevebro

Collaborators

Karolinska University Hospital

Investigators

  • Principal Investigator: Fredrik Klevebro, MD, PhD, Center for Upper Gastrointestinal Cancer, Theme Cancer, Karolinska University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 16, 2021

Primary Completion (Actual)

February 21, 2024

Study Completion (Actual)

February 21, 2024

Study Registration Dates

First Submitted

April 23, 2021

First Submitted That Met QC Criteria

May 3, 2021

First Posted (Actual)

May 4, 2021

Study Record Updates

Last Update Posted (Actual)

October 31, 2024

Last Update Submitted That Met QC Criteria

October 29, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OTIS2019_001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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