Ignite Creation Date:
2024-05-06 @ 4:07 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04871204
Status:
RECRUITING
Last Update Posted:
2022-08-17
First Post:
2021-04-23
Brief Title:
Octreotide Treatment to Improve Nutritional Recovery After Surgery for Patients With Esophageal or Gastric Cancer
Sponsor:
Fredrik Klevebro
Organization:
Karolinska University Hospital
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2022-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OTIS
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 eg 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 11 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
Patient-reported outcome measures PRUs are results reported by the patient himself eg 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 11 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None