The Impact of Oral Nutrition Supplements on the Clinical Outcomes in Gastrointestinal Cancer Patients Undergoing Chemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 175
- 试验地点
- 1
- 主要终点
- Body Composition
研究概览
简要总结
The study hypothesizes that the addition of oral nutrition supplement concurrent chemotherapy treatment to the GI cancer patients will improve the prognosis of cancer cachexia, improve health state quality of life and increase chemotherapy tolerance
详细描述
Malnutrition is a major public health issue in low- and middle-income countries and forms part of the United Nations 2030 Agenda for Sustainable Development Goals .Cancer is a systemic disease, since even in the early stages malignancies are accompanied by homeostatic imbalance, including metabolic deregulation and increased catabolism. These abnormalities may initially seem poorly discernible in the clinic, but with disease progression they may aggravate; and may cause overt cancer-related cachexia.GI cancers show higher mortality than any other kind of cancer. In 2020, they accounted for an estimated 3.5 million deaths worldwide, with a further 5.0 million new cases diagnosed in the same year . Colorectal cancer (CRC) is the most common type of GI cancer, being the third most common of all organ cancers after lung and breast cancers, whereas gastric, liver, esophageal, and pancreatic cancers are ranked the fifth, sixth, eighth, and 12th most commonly diagnosed cancers, respectively
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •GI cancer patients will be included in the study if they meet the following criteria:
- •Confirmed cancer diagnosis any stage or metastatic confirmed by radiological and pathological or by clinical evaluation receiving neo/adjuvant chemotherapy treatment.
- •Age above 18 years old
- •Be accessible for chemotherapy treatment and follow-up
- •Availability to administer oral supplements
- •Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2
- •Life expectancy ≥3 months.
- •Written informed consent according to the local Ethics Committee requirements
- •Willing to fill Nutrition questionnaires.
- •Negative pregnancy test for pre-menopausal women before inclusion in the trial
排除标准
- •The patients will be excluded from the study if they have the following criteria:
- •Known hypersensitivity reaction to the investigational compounds or incorporated substances
- •patients who are unlikely to comply with trial requirements (eg, confusion, psychological or mood disturbances ,alcoholism)
- •Pregnancy or lactating
- •Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent
- •Age < 18 years
- •Indication to or ongoing artificial nutrition support (totally compromised spontaneous food-intake) and incapacity or unavailability to consume ONS
研究组 & 干预措施
Group A
nutrition counselling plus Standard chemotherapy only. Patients will undergo only standard chemotherapy for 3 months
Group B
nutrition counselling plus standard chemotherapy adding oral nutrition supplements as described in manufacturer label daily for 3 month and
干预措施: oral nutrition supplement (Dietary Supplement)
结局指标
主要结局
Body Composition
时间窗: 3 month
measured by DEXA OR BIA
Nutrition status - scored Patient-Generated Subjective Global Assessment (PG-SGA)
时间窗: 3 MONTHS
malnutrition assessment tool. ( 0-1 )No intervention required at this time. Re-assessment on routine and regular basis during treatment. (2-3) Patient \& family education by dietitian, nurse, or other clinician with pharmacologic intervention as indicated by symptom survey and lab values as appropriate. (4-8) Requires intervention by dietitian, in conjunction with nurse or physician as indicated by symptoms . * 9 Indicates a critical need for improved symptom management and/or nutrient intervention options
Anthropometric measures
时间窗: 3 month
Body mass index change
次要结局
- overall response rate(6 months)
- Laboratory data values mean and standard deviation(3 months)
- common adverse effects(6 months)
研究者
ALshaimaa Ibrahim Rabie
Clinical nutrition pharmacist
Beni-Suef University