NCT04871204

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 4, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

June 16, 2021

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 21, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 21, 2024

Completed
Last Updated

October 31, 2024

Status Verified

October 1, 2024

Enrollment Period

2.7 years

First QC Date

April 23, 2021

Last Update Submit

October 29, 2024

Conditions

Esophageal CancerGastric Cancer

Keywords

Weight lossQuality of LifeNutritional recovery

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • Changes in gastrointestinal satiety hormone levels

    Baseline, 7 days post-surgery and at 1, 2, 3 and 6 months

  • Changes in body composition

    Baseline, 1, 2, 3, and 6 months

  • Changes in nutritional status - PG-SGA

    Baseline, 1, 2, 3, and 6 months

  • Changes in nutritional status - EORTC CAX24

    Baseline, 1, 2, 3, and 6 months

  • Health-related Quality of Life - EORTC QLQ-C30

    Baseline, 1, 2, 3 and 6 months

  • +4 more secondary outcomes

Study Arms (2)

Control

NO INTERVENTION

Standard treatment

Octreotide

EXPERIMENTAL

3 monthly intramuscular injections of 10 mg Octreotide

Drug: Octreotide Injection

Interventions

Octreotide InjectionDRUG

10 mg Sandostatin LAR intramuscular injection

Octreotide

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pathologic anatomic analysis (PAD) confirmed esophageal or gastric cancer
  • Gastrectomy or esophagectomy with curative intent
  • ≥18 years of age
  • Signed informed consent
  • Able to comply with the procedures of the study protocol, in the opinion of the investigator
  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska University Hospital, Huddinge

Stockholm, Sweden

Location

MeSH Terms

Conditions

Esophageal NeoplasmsStomach NeoplasmsWeight Loss

Interventions

Octreotide

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesStomach DiseasesBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Peptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Fredrik Klevebro, MD, PhD

    Center for Upper Gastrointestinal Cancer, Theme Cancer, Karolinska University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallell design with Control arm receiving standard treatment and Experimental arm receiving Octreotide treatment
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 23, 2021

First Posted

May 4, 2021

Study Start

June 16, 2021

Primary Completion

February 21, 2024

Study Completion

February 21, 2024

Last Updated

October 31, 2024

Record last verified: 2024-10

Locations

SE(1)