Assessment of the Safety of Dietary Supplement Lactobacillus Fermented Extract in Cancer Patients Undergoing Chemotherapy
试验速览
- 阶段
- 早期 1 期
- 状态
- 撤回
- 发起方
- 主要终点
- Change in self-rated symptoms and assessed signs
研究概览
简要总结
Project: Assessment of the safety of dietary supplement lactobacillus fermented extract in cancer patients undergoing chemotherapy
Nausea and vomiting are significant causes of nutritional depletion and result in further deterioration of the physical and mental status. Support of gastrointestinal function may alleviate nausea and vomiting from chemotherapy and will not only reduce the discomfort experienced by the patient but will allow better tolerance of the treatment. This study will assess orally administered Seigen alpha EV during chemotherapy for its safety and effects on the nutritional depletion deriving from the chemotherapy. It will also look at its effect on the immune system in patients undergoing chemotherapy.
详细描述
Randomization and Treatment: The subjects will be distributed in each of the three cancer categories (breast, lung, and colon), and randomized on centralized randomization lists for each of the cancer categories and assigned a unique identification number in the temporal order of recruitment. Using randomization with the minimization method, subjects will be allocated to treatment or placebo, 15 each for the treatment group or the placebo group, for a total of 30 subjects in each of the 3 cancers. This study utilizes a double-blind.
Placebo: The placebo is identical in packaging and appearance to the treatment. Identification of placebo vs. Seigen alpha EV is by unique packaging code. Patients and study doctors are blinded to the identification interpretation.
Treatment: Treatment will be for a maximum of 3 months. The dosage of the study supplement is as follows: Subjects will be instructed to take 1 packet (6 grams) 3 times daily for a total daily dosage of 3 packets (18 grams). Each packet is clearly marked for breakfast, lunch, or supper. The contents of the packet will be dissolved in water or liquid and taken orally morning, noon, and evening. Subjects will be required to return any unused packets to study doctor at the end of each month.
Assessment:
Usual clinical tests for therapeutic monitoring of usual treatment of patient will be performed.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible subjects have given written informed consent prior to participation
- •They must have a life expectancy of greater than 6 months
- •They must have biopsy confirmed primary breast, colon or lung cancer
- •They are receiving standard chemotherapy in accordance with American Society Clinical Oncology (ASCO) standards and have at least one month remaining in their chemotherapy course
- •They must have an Eastern Cooperative Oncology Group (ECOG) performance status < 2 and are being treated as outpatients.
- •Subjects must be between the ages of 18 to 75 years of age.
- •Subjects must be able to communicate in English.
排除标准
- •Have received radiotherapy within the last 4 weeks
- •Have acute gastrointestinal problems e.g. acute gastrointestinal infection, gastric or duodenal ulcer, history of bowel obstruction, diverticulitis, Crohn's disease, ulcerative colitis, or chronic diarrhea
- •Presence or clinical evidence of CNS metastases
- •Receiving corticosteroids
- •Have severe concomitant disease
- •Have severe dysphagia, esophagitis or xerostoma
研究组 & 干预措施
Intervention group
Seigen Alpha EV Treatment
干预措施: Seigen Alpha EV (Dietary Supplement)
2
Identically packaged placebo packets taken 3x daily for 3 months maximum
干预措施: Placebo Comparator (Dietary Supplement)
结局指标
主要结局
Change in self-rated symptoms and assessed signs
时间窗: 3 months
次要结局
- Affect on treatment results(3 months maximum)