Octreotide Treatment to Improve Nutritional Recovery After Surgery for Patients with Esophageal or Gastric Cancer, a Prospective Randomized Open Label Phase II Study - OTIS
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Weight change in percent (%)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
- •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
研究组 & 干预措施
Octreotide
3 monthly intramuscular injections of 10 mg Octreotide
干预措施: Octreotide Injection (Drug)
结局指标
主要结局
Weight change in percent (%)
时间窗: 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
次要结局
- 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)
- Health-related Quality of Life - QLQ-OG25(Baseline, 1, 2, 3 and 6 months)
- Percentage (of subjects) in need of enteral nutrition(Baseline, 1, 2, 3 and 6 months)
- Number and type of Adverse Events(From 7 days post-surgery and at 1, 2, 3 and 6 months (continuously))
- Number of patients completing treatment(From first treatment at 7 days post-surgery to last treatment at 2 months)
研究者
Fredrik Klevebro
Principal Investigator
Karolinska University Hospital