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 primary objective of this study is to determine if **intramuscularly** administered octreotide can decrease weight loss after gastrectomy or esophagectomy due to **esophageal and gastric cancer**. This is clinically relevant as weight loss is a common and significant complication following these surgical procedures, impacting patient recovery and overall prognosis.

Secondary objectives include:

• To study if octreotide treatment affects the levels of gastrointestinal satiety hormones.
• To determine if octreotide treatment affects body composition.
• To determine if octreotide treatment affects postoperative health-related quality of life.
• To study if postoperative eating problems can be reduced by intramuscular administration of octreotide.
• To study safety and tolerability of treatment with intramuscularly administered octreotide after gastrectomy or esophagectomy due to cancer.

The clinical trial focuses on individuals diagnosed with **esophageal and gastric cancer**. The study population includes both male and female participants, aged 18 years and older, who have undergone gastrectomy or esophagectomy with curative intent. Participants are required to have a pathologic anatomic analysis confirming their cancer diagnosis. The trial does not specify the total number of participants, as this information was not provided by the sponsor. The selection process ensures that participants are capable of complying with the study protocol, as assessed by the investigator. Women of child-bearing potential are included only if they meet specific criteria regarding pregnancy testing and contraception. The trial population is considered vulnerable, highlighting the need for careful ethical considerations. Lifestyle factors such as diet and physical activity are not detailed in the available data.

The clinical trial is designed to evaluate the efficacy of **octreotide** in improving nutritional recovery following surgery for patients with esophageal or gastric cancer. This is a prospective, randomized, open-label, phase II study. The trial aims to determine if intramuscular administration of octreotide can reduce weight loss after gastrectomy or esophagectomy. The study is expected to run until June 30, 2025, with recruitment having commenced on October 5, 2021. Participants will be involved in the study for a maximum treatment period of two months, with the primary endpoint being the percentage of weight loss from baseline measured at 1, 2, 3, and 6 months post-surgery.

Study visits are structured to include an initial screening visit to confirm eligibility, followed by baseline assessments prior to surgery. Follow-up visits are scheduled at 7 days post-surgery and at 1, 2, 3, and 6 months to monitor weight loss, body composition, and health-related quality of life. Secondary endpoints include the measurement of specific biomarkers such as S-GLP-1, S-PYY, S-Ghrelin, and S-GIP, as well as the assessment of adverse events associated with the treatment. The end-of-study visit will coincide with the final follow-up at 6 months.

Participants are required to meet specific inclusion criteria, including a confirmed diagnosis of esophageal or gastric cancer, having undergone surgery with curative intent, and being at least 18 years of age. Women of child-bearing potential must adhere to strict contraceptive measures. Conditions that may lead to early termination from the study include non-compliance with study procedures or the occurrence of significant adverse events. The trial is not categorized as low intervention and is conducted under the regulatory framework for phase II clinical trials.

The clinical trial involves the administration of **octreotide**, marketed under the name Sandostatin LAR 10 mg, which is provided as a **suspension for injection**. The pharmaceutical form consists of a powder and liquid that are combined to create the suspension. The active substance, octreotide, is a synthetic analog of somatostatin, classified under the ATC code H01CB02. The medication is administered via **intramuscular injection**. The dosage is set at 10 mg, with a maximum daily and total dose of 10 mg. The treatment period is limited to a maximum of two months. The product is manufactured by Novartis Sverige AB and is not designated as an orphan drug. The formulation is not specifically for pediatric use.

In this study, octreotide is being evaluated for its potential to decrease weight loss in patients undergoing gastrectomy or esophagectomy due to esophageal or gastric cancer. The trial is designed as a prospective, randomized, open-label phase II study. The primary objective is to assess the efficacy of intramuscularly administered octreotide in improving nutritional recovery post-surgery. No non-experimental treatments, such as standard-of-care therapy, placebo, or comparator treatments, are specified in the trial documentation. Participant compliance with the dosing schedule will be monitored throughout the study duration to ensure adherence to the treatment protocol.

Efficacy in this clinical trial will be assessed primarily by evaluating the percentage of weight loss from baseline weight before surgery. This will be measured continuously at 1, 2, 3, and 6 months post-surgery. Secondary endpoints include the measurement of specific biomarkers such as S-GLP-1, S-PYY, S-Ghrelin, and S-GIP, which will be assessed at baseline, 7 days post-surgery, and at 1, 2, 3, and 6 months. Body composition will be evaluated in terms of body fat percentage and through the use of the PG-SGA and EORTC CAX24 questionnaires. Health-related Quality of Life (HRQOL) will be measured using the EORTC QLQ-C30 and QLQ-OG25 instruments, focusing on esophageal cancer-specific symptoms, at baseline and at 1, 2, 3, and 6 months after randomization. Additional secondary endpoints include the percentage of subjects requiring enteral nutrition via a jejunostomy feeding catheter or nasogastric tube, the number and type of adverse events, and the number of patients completing treatment. The trial aims to determine if intramuscularly administered **octreotide** can decrease weight loss following gastrectomy or esophagectomy due to cancer.