The Safety and Efficacy Test of Nutri-PEITC Jelly in Head and Neck Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 96
- 试验地点
- 5
- 主要终点
- Changes in Health-related quality of life score compared to baseline
研究概览
简要总结
This triple-blinded randomized placebo control trial aims to investigate the safety and efficacy of Nutri-PEITC jelly, a functional food, in head and neck cancer patients. The primary outcome measure includes adverse events, health-related quality of life, tumor response and progression-free survival. The secondary outcome includes serum p53 and cytochrome C levels and functional status.
详细描述
Previously, Nutri-jelly, a novel edible nutritious gel for patients with chewing and swallowing difficulties, was shown to be effective in improving the quality of life of head and neck cancer patients. Recently, Nutri-PEITC jelly is recently developed by addition of Phenethyl Isothiocyanate (PEITC), a phytochemical compound with chemopreventive action in animal bearing oral cancer. It intends to be a functional food for cancer survivor. The dose of PEITC in Nutri-jelly was based on safe and effective dose determined in animal studies. Furthermore, Nutri-PEITC jelly was proven safe in healthy volunteers who daily consumes for a consecutive month with no serious adverse events. The purpose of this study is to determine safety and efficacy of Nutri-jelly with PEITC in head and neck cancer patients.
independent variable: continuous Nutri -jelly with PEITC intake dependent variable (outcome): adverse effects, health-related quality of life score, tumor response, progression-free survival, serum p53 and cytochrome C levels and functional status
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of squamous cell carcinoma in areas of lip, oral cavity, oropharynx and hypopharynx, who receive only palliative care or deny definitive treatment
- •Finished radiotherapy or/and chemotherapy for at least one month
- •Has at least one measurable target lesion
- •Baseline KPS ≥ 40% or ECOG 0-3
- •Blood tests are in acceptable ranges (neutrophils ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L; Hb ≥ 9.0 g/dL), renal function (clearance creatinine using the CKD-EPI formula (Chronic Kidney Disease Epidemiology group) ≥50 mL/min) and hepatic function (SGOT , SGPT, serum bilirubin ≤ 1.5 of upper limits of normal
- •Able to take the intervention (through mouth or NG tube) without aspiration
- •Able to communicate and consent to the study
排除标准
- •Cannot come back for the follow-up visits
- •Receive or had received N-acetylcysteine during the intervention
- •Has systemic diseases that might interfere with the results
- •Chronic kidney disease that requires dialysis
- •Increased risk of aspiration pneumonia
- •Pregnancy or lactation
- •Untreated infectious diseases
研究组 & 干预措施
Nutri-jelly with PEITC
Continuous intake of 200 g Nutri-jelly with 20 mg PEITC per day, five days per week for 3 months.
干预措施: Nutri-jelly with PEITC (Dietary Supplement)
Nutri-jelly
Continuous intake of 200 g Nutri-jelly per day, five days per week for 3 months.
干预措施: Nutri-jelly (Dietary Supplement)
结局指标
主要结局
Changes in Health-related quality of life score compared to baseline
时间窗: Baseline, 1 month and 3 months after receiving intervention
Evaluation of Health-related quality of life by using questionnaire FACT-HN
Progression-free survival time
时间窗: The time of the intervention until any signs or symptoms of progressive disease be recorded.
The length of time during the intervention that the participant lives with stable disease
Adverse events
时间窗: 1 month and 3 months after receiving intervention
Evaluation of adverse events by physical examination, blood tests, and interviewing the subjects
Changes in Tumor response compared to baseline
时间窗: Baseline, 1 month, 3 months after receiving intervention
Evaluation of tumor response following RECIST criteria at 1 month and 3 months
次要结局
- Serum p53 level(1 month and 3 months after receiving intervention)
- Serum cytochrome C level(1 month and 3 months after receiving intervention)
- Changes in Functional status(Baseline, 1 month and 3 months after receiving intervention)