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Octreotide treatment to improve nutritional recovery after surgery for patients with esophageal or gastric cancer, a prospective randomized open label phase II study - OTIS
EU CTIS ID: 2022-502745-98-00
What this study is testing
To determine if intramuscularly administered octreotide can decrease weight loss after gastrectomy or esophagectomy due to cancer.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join 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. Acceptable birth control methods are those with a failure rate of less than 1% per year when used consistently and correctly (a list of approved methods is provided in appendix D). An additional pregnancy test is to be provided at end of exposure.
You likely can't join if
- Non-radical operation (defined by macroscopic assessment) or metastatic disease diagnosed at the time of surgery
- 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.
- Complications leading to restrictions in postoperative oral intake
See the full eligibility criteria
- 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. Acceptable birth control methods are those with a failure rate of less than 1% per year when used consistently and correctly (a list of approved methods is provided in appendix D). An additional pregnancy test is to be provided at end of exposure.
- Non-radical operation (defined by macroscopic assessment) or metastatic disease diagnosed at the time of surgery
- 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.
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.