Clinical trial NCT04871204: Octreotide Treatment to Improve Nutritional Recovery After Surgery for Patients with Esophageal or Gastric Cancer
Official title: Octreotide Treatment to Improve Nutritional Recovery After Surgery for Patients with Esophageal or Gastric Cancer, a Prospective Randomized Open Label Phase II Study - OTIS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Esophageal Cancer
Gastric Cancer
Keywords: Weight loss
Quality of Life
Nutritional recovery
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
Collaborators: name: Karolinska University Hospital
First posted: 2021-05-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallell design with Control arm receiving standard treatment and Experimental arm receiving Octreotide treatment
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Weight change in percent (%)
timeFrame: From baseline before surgery, at 1, 2, 3, and 6 months
Secondary outcomes:
measure: Changes in gastrointestinal satiety hormone levels
timeFrame: Baseline, 7 days post-surgery and at 1, 2, 3 and 6 months
measure: Changes in body composition
timeFrame: Baseline, 1, 2, 3, and 6 months
measure: Changes in nutritional status - PG-SGA
timeFrame: Baseline, 1, 2, 3, and 6 months
measure: Changes in nutritional status - EORTC CAX24
timeFrame: Baseline, 1, 2, 3, and 6 months
measure: Health-related Quality of Life - EORTC QLQ-C30
timeFrame: Baseline, 1, 2, 3 and 6 months
measure: Health-related Quality of Life - QLQ-OG25
timeFrame: Baseline, 1, 2, 3 and 6 months
measure: Percentage (of subjects) in need of enteral nutrition
timeFrame: Baseline, 1, 2, 3 and 6 months
measure: Number and type of Adverse Events
timeFrame: From 7 days post-surgery and at 1, 2, 3 and 6 months (continuously)
measure: Number of patients completing treatment
timeFrame: From first treatment at 7 days post-surgery to last treatment at 2 months
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital, Huddinge
Study officials:
affiliation: Center for Upper Gastrointestinal Cancer, Theme Cancer, Karolinska University Hospital
name: Fredrik Klevebro, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: