Head and Neck Cancer Immunonutrition Supplementation During Cancer Treatment: A Randomized, Open-label Intervention Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 116
- 试验地点
- 4
- 主要终点
- Body weight (kilograms)
研究概览
简要总结
This is a prospective, randomized, open-label intervention study to evaluate the effectiveness of immunonutrition supplementation in head and neck cancer (HNC) patients during cancer treatment.
详细描述
The study population will be adult HNC patients receiving radiotherapy and chemotherapy treatment. The targeted number of subjects is 116 patients (58 subjects in each arm). Participants will be randomly assigned to receive standard medical nutrition therapy (individualized dietary assessment and counselling, and standard nutrition supplementation as necessary) or standard medical nutrition therapy with high energy, high protein, immunonutrient-enriched oral nutrition supplementation. Immunonutrition supplementation will begin 1 week prior to cancer treatment and continued throughout the cancer treatment, and to be taken in 3 servings/day. The study involves interviewing of subjects for dietary and nutrition assessment; measurement of weight, body composition, handgrip strength; and data collection from subjects' medical records.
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
- •Written informed consent obtained
- •Adult HNC patients, male or female, above 18 years of age
- •Primary HNC diagnosis, stage I to III; including: cancer of the nasopharynx, oropharynx, oral cavity, hypopharynx, or larynx, etc.
- •Referred and planned for curative-intent cancer treatment (radiotherapy and chemotherapy)
- •Eastern Cooperative Oncology Group (ECOG) performance status < 2
排除标准
- •Inability or unwillingness to provide written informed consent or comply with the requirements of the protocol
- •Patients with metastatic stage or recurring/relapse of cancer at same site
- •Planned for palliative cancer treatment
- •Underlying severe hepatic failure or renal dysfunction (eGFR < 30ml/min/1.73m2)
- •Underlying severe sepsis, neutropenia, immune-deficiencies or autoimmune diseases
- •Consumption of supplements or enriched foods containing immunonutrients (omega- 3, arginine or nucleotides) in the previous month prior to study; including dietary supplements such as: fish oil capsules, arginine tablets/powder, RNA capsules, etc.
- •Known allergy or intolerance to components of the immunonutrition supplement (cow's milk, fish or soy)
- •Enrolment in other cancer treatment trials
结局指标
主要结局
Body weight (kilograms)
时间窗: Baseline, weekly review during cancer treatment, 1month post-completion of cancer treatment
Changes in body weight during study period
Nutrition status - 3-Minute Nutrition Screening (3-minNS) tool
时间窗: Baseline, initiation of cancer treatment, completion of cancer treatment, 1month post-completion of cancer treatment
Changes in nutrition status during study period (score of 3 to 4 indicates risk of moderate malnutrition, and score of 5 to 9 indicates risk of severe malnutrition)
Nutrition status - scored Patient-Generated Subjective Global Assessment (PG-SGA)
时间窗: Baseline, initiation of cancer treatment, completion of cancer treatment, 1month post-completion of cancer treatment
Changes in nutrition status during study period (3 categories: A- well nourished, B- moderately or suspected of being malnourished, and C- severely malnourished)
次要结局
- Handgrip strength(Baseline, initiation of cancer treatment, completion of cancer treatment, 1month post-completion of cancer treatment)
- Functional status - Eastern Cooperative Oncology Group (ECOG) Performance Status Score(Baseline, initiation of cancer treatment, completion of cancer treatment, 1month post-completion of cancer treatment)