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

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: Gastric Cancer; Esophageal Cancer
• Intervention / Treatment: Drug: Octreotide Injection

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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 (%)	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	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	Body composition measured in percent (%) body fat (continuously)	Baseline, 1, 2, 3, and 6 months
Changes in nutritional status - PG-SGA	Nutritional status measured with the questionnaire PG-SGA	Baseline, 1, 2, 3, and 6 months
Changes in nutritional status - EORTC CAX24	Nutritional status measured with the questionnaire EORTC CAX24	Baseline, 1, 2, 3, and 6 months
Health-related Quality of Life - EORTC QLQ-C30	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	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	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	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	Number of patients completing treatment	From first treatment at 7 days post-surgery to last treatment at 2 months

Collaborators and Investigators

• 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

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: Quality of Life; Weight loss; Nutritional recovery
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms; Antineoplastic Agents; Gastrointestinal Agents; Antineoplastic Agents, Hormonal; Octreotide
• 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