Esophageal CancerPhase 2OTISNCT04871204
Octreotide Treatment to Improve Nutritional Recovery After Surgery for Patients with Esophageal or Gastric Cancer
A Phase 2 study testing Octreotide Injection in people with Esophageal Cancer and Gastric Cancer, run by Fredrik Klevebro at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer, Gastric Cancer
- What is being tested?
- Octreotide Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSweden
- Study dates
- 16 Jun 2021to 21 Feb 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Esophageal Cancer, Gastric Cancer
- Being tested
- Octreotide Injection
- Keywords
- Weight loss, Quality of Life, Nutritional recovery
- Medical subject headings
- Esophageal Neoplasms, Stomach Neoplasms, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Octreotide InjectionDrug
10 mg Sandostatin LAR intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Standard treatment |
| Octreotide | Experimental | 3 monthly intramuscular injections of 10 mg Octreotide Receives: Drug: Octreotide Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight change in percent (%)
Weight loss in percent (%) from baseline weight before surgery, measured at 1, 2, 3, and 6 months after surgery
Measured: From baseline before surgery, at 1, 2, 3, and 6 months
Secondary outcomes (9)
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.
Measured: 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)
Measured: Baseline, 1, 2, 3, and 6 months
Changes in nutritional status - PG-SGA
Nutritional status measured with the questionnaire PG-SGA
Measured: Baseline, 1, 2, 3, and 6 months
Changes in nutritional status - EORTC CAX24
Nutritional status measured with the questionnaire EORTC CAX24
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: From 7 days post-surgery and at 1, 2, 3 and 6 months (continuously)
Number of patients completing treatment
Number of patients completing treatment
Measured: From first treatment at 7 days post-surgery to last treatment at 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2021
- Study start16 Jun 2021
- Primary completion21 Feb 2024
- Study completion21 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallell design with Control arm receiving standard treatment and Experimental arm receiving Octreotide treatment
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fredrik Klevebro
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska University Hospital
- Responsible party
- Sponsor-investigator, Fredrik Klevebro, Karolinska University Hospital
- Investigators
- Fredrik Klevebro, MD, PhD, Principal investigator, Center for Upper Gastrointestinal Cancer, Theme Cancer, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04871204
- Sponsor's protocol ID
- OTIS2019_001
- Acronym
- OTIS
- Status last verified
- Oct 2024
- First submitted
- 23 Apr 2021
- Last updated
- 31 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04871204
- Acronym / sponsor ID
- OTIS / OTIS2019_001
- Conditions
- Esophageal Cancer, Gastric Cancer
- Keywords
- Weight loss, Quality of Life, Nutritional recovery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Fredrik KlevebroUniversity, hospital or other
- Collaborators
- Karolinska University Hospital
- Study start
- 16 Jun 2021 (actual)
- Primary completion
- 21 Feb 2024 (actual)
- Study completion
- 21 Feb 2024 (actual)
- First posted
- 4 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallell design with Control arm receiving standard treatment and Experimental arm receiving Octreotide treatment
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Standard treatment |
| Octreotide | Experimental | Drug: Octreotide Injection3 monthly intramuscular injections of 10 mg Octreotide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Octreotide Injection10 mg Sandostatin LAR intramuscular injection | Drug | Octreotide |
Primary outcome
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
9 secondary outcomes
Changes in gastrointestinal satiety hormone levels
Time frame: 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
Changes in nutritional status - PG-SGA
Time frame: Baseline, 1, 2, 3, and 6 months
Changes in nutritional status - EORTC CAX24
Time frame: 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 - QLQ-OG25
Time frame: Baseline, 1, 2, 3 and 6 months
Percentage (of subjects) in need of enteral nutrition
Time frame: 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 of patients completing treatment
Time frame: From first treatment at 7 days post-surgery to last treatment at 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fredrik Klevebro, MD, PhD principal investigator
Center for Upper Gastrointestinal Cancer, Theme Cancer, Karolinska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Octreotide Injection in people with Esophageal Cancer and Gastric Cancer, run by Fredrik Klevebro at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight change in percent (%) (time frame: From baseline before surgery, at 1, 2, 3, and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2024.