NCT00936728已完成不适用
White Wine for Appetite Loss: A Randomized, Controlled, Non-Blinded Trial
Academic and Community Cancer Research United6 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2009年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 6
- 主要终点
- Difference in the percentage of patients who report an improvement in their appetite over the intervention period
研究概览
简要总结
RATIONALE: It is not yet know whether white wine is more effective than a nutritional supplement in improving appetite.
PURPOSE: This randomized clinical trial is studying white wine to see how well it works compared with a nutritional supplement in improving appetite in patients with cancer
详细描述
OBJECTIVES:
I. To compare white wine (Arm A) to non-wine nutritional supplement (Arm B) for the treatment of cancer-associated anorexia.
II. To evaluate the side effect profile of white wine (Arm A).
OUTLINE: Patients are stratified according to primary malignant disease (lung vs gastrointestinal vs other [specify]), severity of weight loss (excluding peri-operative weight loss) within the past 2 months (< 4.6 kg [< 10 lbs] vs >= 4.6 kg [>= 10 lbs]), age (< 50 years vs >= 50 years), and planned concurrent chemotherapy or radiation (yes vs no).
Patients are randomized to 1 of 2 arms.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Incurable, invasive malignancy
- •Able to reliably take the study intervention as prescribed in this protocol
- •No prior or current history of alcoholism
- •Alert and mentally competent
- •Physician estimates that patient has lost >= 5 pounds (2.3 kg) in weight =< 2 months (excluding peri-operative weight loss; documented weight loss not required) and/or have estimated caloric intake of < 20 cal/kg daily (no further documentation necessary other than an affirmative answer to this statement)
- •Patient perceives loss of appetite and/or weight as a problem; NOTE: Documentation not necessary
- •Concurrent chemotherapy and/or radiotherapy are permitted
- •Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only
- •Willingness to abstain completely from alcohol for 4 weeks, except as prescribed in this trial; NOTE: Patients assigned to the non-wine nutritional supplement (Arm B) must be willing to abstain from wine and other alcoholic beverages for 3-4 weeks; Patients assigned to the white wine (Arm A) are allowed to take a nutritional supplement, such as Ensure or Boost if they choose to
- •Ability to complete questionnaire(s) by themselves or with assistance
- •Willingness to return to MCCRC enrolling institution for follow-up
- •Patients in whom the use of progestational agents is anticipated are not permitted to be on this study
- •Short-term use of dexamethasone around days of intravenous chemotherapy is allowed for protection against emesis, but dexamethasone for appetite stimulation is not permitted
排除标准
- •Receiving tube feedings or parenteral nutrition
- •Current (=< 1 month) or planned treatment with adrenal corticosteroids (short-term use of dexamethasone around days of chemotherapy is allowed for protection against emesis), androgens, or progestational agents; EXCEPTION: Inhalant, topical, or optical steroid use is permissible
- •Progestational agent (such as megestrol acetate) planned to be initiated over the next 30 days; NOTE: Patients who have been on megestrol acetate for > 1 month and are still on it and otherwise meet the eligibility criteria are permitted to enroll on this protocol and remain on megestrol acetate
- •Known mechanical obstruction of the alimentary tract, malabsorption, or intractable vomiting (> 5 episodes/week)
- •Symptomatic or untreated brain metastases
- •Any of the following as this regimen may be harmful to a developing fetus or nursing child: pregnant women, nursing women, and men or women of childbearing potential who are unwilling to employ adequate contraception
结局指标
主要结局
Difference in the percentage of patients who report an improvement in their appetite over the intervention period
时间窗: First 3 weeks
次要结局
- Differences in the percentage of patients who manifest weight stability, defined as weight gain of at least 5% of baseline(At one month)
- Overall survival(Every 6 months for 2 years)
- Patient-reported quality of life (QOL) as measured by the Functional Assessment of Anorexia/Cachexia Therapy (FAACT) appetite scale(Prior to study intervention and then weekly)
- Incidence of study intervention-related toxicity(Prior to registration and at week 3-4)
研究者
研究点 (6)
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