A Phase II Study Examining the Role of Fermented Soy Beverage for Improving Cancer-Associated Anorexia and Cachexia
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Change in Severity of Poor Appetite Following Treatment With Haelan (Fermented Soy Product)
研究概览
简要总结
Primary:
- To determine if treatment with Haelan (fermented soy product) can decrease the severity of poor appetite measured using a visual analog scale (VAS) of 0 to 100 mm (0 mm = best, 100 mm = worst) at week 4 +/- 5 days.
- To determine if treatment with Haelan can decrease the severity of nausea, fatigue, and improve patients' overall sense of well being measured using a VAS of 0 to 100 mm (0 mm = best, 100 mm = worst) at week 4 +/- 5 days.
- To determine if treatment with Haelan can increase patient's calorie intake, albumin, pre-albumin, anthropometric measure, lean body mass (measured by bio-impedence analysis), and weight at week 4+/- 5 days.
- To determine if treatment with Haelan can decrease patient's Functional assessment of anorexia/cachexia therapy subscales or (FAACT) and the Functional Assessment of Chronic Illness Therapy with fatigue subscales (FACIT-F) at week 4+/- 5 days.
- To assess the feasibility of accrual, and adherence to the Haelan consumption.
Secondary:
- Determine the plasma isoflavone activity, 12-MTA and 13-MTA of these patients.
- Correlate the biologic modulation of peripheral blood lymphocyte NF-kB by Haelan with primary outcome in these patients.
- To determine if treatment with Haelan can increase patient's functional status at week 4+/- 5 days.
详细描述
Individuals who have cancer-related malnutrition have also been found to have a higher risk of complications and are less able to tolerate the side effects of conventional therapies such as chemotherapy, radiation, and surgery.
Haelan is a soy-based liquid (beverage). It contains large amount of isoflavones. Isoflavones inhibit "nuclear factor-kappa B," which may lead to prevention of weight loss.
If you are eligible to take part in this study, you will then be given 2 fluid ounces of Haelan, as a taste test. If you are not able to tolerate the taste of Haelan, you will not be eligible for this study.
If you are able to pass the taste test and you are a woman who is able to have children, you will be asked to have a pregnancy test 24 hours prior to registration to Part B. Then only if you test negative for the pregnancy test will you be considered eligible for this study. If you are a female patient and refuse to practice accepted methods of contraceptives during the study, you will not be eligible for this study.
If you are still eligible for this study, you will have about 6 teaspoons of blood drawn, for baseline routine tests. Your height and weight will be measured. You will be instructed by a research nurse to recall your one day food intake before starting treatment. You will be asked about any medications you are taking (especially any appetite stimulants, such as megestrol, corticosteroid, and marinol), including the dose and when you take them. If you are able to tolerate the taste of Haelan, you will be instructed to drink 4 ounces of Haelan soy beverage 2 times a day, on an empty stomach, for 8 weeks. You may add water, stevia, honey or artificial sweeteners into Haelan prior to drinking it to improve the tolerance of Haelan. If you are unable to tolerate 4 ounces of Haelan twice a day after 2 attempts, the dose will be reduced to 2 ounces twice a day. If you are still not able to tolerate it after 2 attempts, the dose will be reduced again to 1 ounce twice a day. If you still cannot tolerate drinking this Haelan dose after 2 more attempts, the dose will be reduced again to 1 ounce daily. If you cannot tolerate at least 1 ounce a day for 5 consecutive days, you will be taken off this study. If you vomit within half hour of taking the Haelan, you should try at least 2 more times to drink at least 1 ounce of Haelan on the same day. If unsuccessful, please record that you were not able to take the Haelan on that day. If you cannot tolerate at least 1 ounce of Haelan a day for 5 days in a row, you will be taken off this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Anorexia (defined as > 30mm on a visual analog scale [VAS] of 0 to 100mm)
- •Weight loss (defined as weight loss > 5% within last 6 months)
- •Normal cognition (per treating physician's opinion)
- •Written informed consent
- •Advanced solid tumor (defined as locally recurrent or metastatic disease)
- •Patient must have perceived weight loss as a problem.
- •Able to maintain oral food intake within one week prior to enrollment in this study.
排除标准
- •Evidence of ascites (per treating physician's opinion).
- •Receiving supplementary tube feedings or parenteral nutrition
- •Known mechanical obstruction of the alimentary tract, or intractable vomiting
- •Add or change dose of the following medication within 2 weeks prior to this trial or during this trial: megestrol, corticosteroid, mirtazapine, metoclopramide and dronabinol, with the exception of pre-medication for chemotherapy (10-20 mg Decadron intavenous (IV) once and/or Reglan 10 mg IV x1 prior to chemotherapy).
- •Allergic to soy.
- •Positive pregnancy test for female patients of child-bearing potential. (Definition of child-bearing potential: not post-menopausal for past 12 months or nor surgically sterile)
- •Female patients with child bearing potential, but refuse to practice accepted methods of contraception (acceptable forms of contraception include: continuous abstinence, Depo-Provera shot, tubal ligation, NuvaRing vaginal ring, Ortho Evra skin patch, oral contraceptive, IUD-Mirena, vasectomy, male condom, diaphragm).
- •Weight less than 80 lb.
- •Patient who could not tolerate oral intake of 2 Oz. of Haelan during the taste test.
- •Diagnosed of breast cancer.
研究组 & 干预措施
Fermented Soy Supplement
4 oz Haelan orally twice daily for 8 weeks
干预措施: Haelan (Drug)
结局指标
主要结局
Change in Severity of Poor Appetite Following Treatment With Haelan (Fermented Soy Product)
时间窗: Baseline and Week 4 +/- 5 days
Change in severity of poor appetite measured using a visual analog scale (VAS) of 0 to 100 mm (0 mm = best, 100 mm = worst) at week 4 +/- 5 days.
次要结局
未报告次要终点