NCT00486304已完成1 期
Phase I Randomized, Double-blind, Placebo-controlled Trial of the Effect of Temporary Dietary Antioxidant Depletion on Tumor Growth and Cachexia in Head and Neck Cancer Patients Receiving Chemoradiation Therapy
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Number of people with adverse events
研究概览
简要总结
RATIONALE: Eating a diet that is low in antioxidants may control cachexia in patients with oropharyngeal cancer.
PURPOSE: This randomized phase I trial is studying the side effects of a low antioxidant diet in controlling cachexia in patients with oropharyngeal cancer receiving chemotherapy and radiation therapy.
详细描述
OBJECTIVES:
Primary
- Determine the safety of the antioxidant-deficient diet (ADD) in controlling cachexia in patients with oropharyngeal cancer receiving chemoradiotherapy.
Secondary
- Determine the safety of the ADD as measured by quality of life, peripheral DNA damage, and change in body weight.
- Determine the effectiveness of the ADD on tumor growth and surrogate markers of tumor growth.
- Determine whether the ADD is effective in improving the tumor cachexia syndrome in these patients.
- Determine whether there is a serum metabolomic signature for the ADD.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Biopsy-proven carcinoma of the oropharynx (regardless of primary diagnosis or recurrence)
- •No active treatment for disease within the past 4 weeks
- •PATIENT CHARACTERISTICS:
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •Feeding tubes allowed
- •Prior malignancies allowed provided all of the following criteria are met:
- •Patient has undergone potentially curative therapy for all prior malignancies
- •There has been no evidence of any prior malignancies within the past 5 years (except for successfully treated cervical or non-melanoma skin cancer with no evidence of recurrences)
- •Patient is deemed by their treating physician to be at low risk for recurrence from prior malignancies
- •Must be able to speak English
- •Must have adequate home refrigeration
- •No intractable vomiting
- •No ascites or clinical/ultrasound evidence of fluid retention
- •No uncontrolled hypertension
- •No severe congestive heart failure
- •No pneumonia
- •No severe infections
- •No known HIV positivity
- •No coexisting medical condition that would preclude study compliance
- •No decisionally-impaired individuals
- •No history of abetalipoproteinemia (Bassen-Kornzweig syndrome)
- •No history of spinocerebellar ataxia
- •No history of chronic cholestatic hepatobiliary disease
- •No history of diagnosed vitamin E deficiency
- •No history of protein-energy malnutrition (marasmus or kwashiorkor)
- •No history of disorders related to malabsorption (e.g., celiac disease, sprue, cystic fibrosis, duodenal bypass, congenital partial obstruction of the jejunum, obstruction of the bile ducts, giardiasis, or cirrhosis)
- •No history of achlorhydria
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •No concurrent parenteral nutrition
排除标准
- 未提供
研究组 & 干预措施
Antioxidant-deficient diet (ADD)
Experimental
干预措施: ADD (Other)
Placebo
Placebo Comparator
干预措施: Placebo (Other)
结局指标
主要结局
Number of people with adverse events
时间窗: 70 days
Estimate the safety of the antioxidant-deficient diet (ADD) by measuring the frequency of grade 3 or 4 adverse events, per CTCAE criteria
次要结局
未报告次要终点
研究者
研究点 (1)
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