NCT01545687撤回3 期
A Phase III, Randomized, Double-Blind Study of Lactobacillus Brevis CD2 Lozenges Versus Placebo in the Prevention of Acute Oral Mucositis (OM) in Patients With Head and Neck Cancer Receiving Concurrent Radiotherapy and Chemotherapy
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 主要终点
- The AUC of the MTS score
研究概览
简要总结
RATIONALE: Lactobacillus bevis CD2 lozenge may help prevent symptoms of mucositis, or mouth sores, in patients receiving radiation therapy and chemotherapy. This therapy may improve the quality of life of patients with head and neck cancer.
PURPOSE: This phase III trial studies how well Lactobacillus bevis CD2 lozenge prevents oral mucositis in patients with head and neck cancer who are being treated with cisplatin and radiation therapy. These results will be compared to results in patients using placebo lozenges.
详细描述
OBJECTIVES:
Primary
- To determine whether Lactobacillus brevis CD2 lozenges are effective in reducing oral mucositis (OM)-related pain in patients undergoing chemoradiotherapy (CRT) for head and neck squamous cell carcinoma, as measured by the area under the curve (AUC) of Mouth and Throat Soreness (MTS) score (Oral Mucositis Daily Questionnaire [OMDQ] question 2) measured daily during CRT and daily for 4 weeks after completion of CRT.
Secondary
- To assess whether L. brevis CD2 lozenges reduce OM as assessed by the provider using the WHO OM scale, Oral Mucositis Assessment Scale (OMAS), and Common Terminology Criteria Adverse Events (CTCAE).
- To assess whether L. brevis CD2 lozenges reduce the impact of OM on the ability to swallow, drink, eat, talk, and sleep, as assessed by the MTS-Activity Limitations (MTS-AL).
- To assess whether L. brevis CD2 lozenges improve quality of life, as assessed by the Functional Assessment of Cancer Therapy - Head and Neck (FACT-HN).
- To assess whether L. brevis CD2 lozenges reduce opioid requirements.
- To assess whether L. brevis CD2 lozenges improve radiotherapy compliance.
- To assess whether L. brevis CD2 lozenges reduce weight loss and the need for a feeding tube.
- To assess whether L. brevis CD2 lozenges affect disease-free survival (DFS) at 12 months after treatment.
- To evaluate the effect of L. brevis CD2 lozenges on salivary biomarkers, including metabonomic and inflammatory markers, as measured at baseline, week 3 of CRT, and during the last week of CRT. (exploratory)
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
- Double (Participant, 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:
- •Histologic proof of squamous cell carcinoma of the oral cavity, oropharynx, nasopharynx, hypopharynx, or larynx
- •Planned course of definitive or post-operative radiotherapy (RT) to a total dose of ≥ 60 Gy using 1.8 to 2.0 Gy per fraction
- •At least one third of the oral cavity mucosa must be included in the RT fields, as estimated by the treating radiation oncologist
- •Planned concurrent administration of cisplatin chemotherapy (either 100 mg/m^2 every 3 weeks or 30-40 mg/m^2 every week)
- •PATIENT CHARACTERISTICS:
- •ECOG performance status (PS) 0, 1, or 2
- •Hemoglobin ≥ 10.0 g/dL
- •White blood cell (WBC) ≥ 3,500 x10^9/L
- •Absolute neutrophil count (ANC) ≥ 1,500 x10^9/L
- •Platelet count ≥ 100,000 x10^9/L
- •Willing to abstain from ingestion of yogurt products and/or any product containing probiotics during study drug treatment
- •Ability to complete questionnaire(s) by themselves or with assistance
- •Willing to provide saliva samples for correlative research purposes (first 50 patients)
- •Not pregnant or nursing
- •Negative pregnancy test done ≤ 7 days prior to registration, for women of childbearing potential
- •Men or women of childbearing potential must employ adequate contraception
- •No co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
- •No current untreated oral candidiasis, oral herpes simplex virus (HSV) infection, or oral mucositis
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •No split-course RT planned
- •No prior head and neck RT
排除标准
- 未提供
研究组 & 干预措施
Arm I
Experimental
Patients dissolve in mouth 1 lozenge of Lactobacillus bevis CD2 every 2-3 hours (total of 6 per day) daily during CRT (comprising cisplatin and radiotherapy [RT]) and for 4 weeks after, including weekends.
干预措施: Lactobacillus brevis CD2 lozenge (Dietary Supplement)
Arm II
Placebo Comparator
Patients dissolve in mouth 1 lozenge of placebo every 2-3 hours (total of 6 per day) daily during CRT and for 4 weeks after, including weekends.
干预措施: placebo (Other)
结局指标
主要结局
The AUC of the MTS score
时间窗: Up to 12 months
次要结局
- OM measured by WHO OM scale, OMAS and CTCAE weekly during CRT(Up to 12 months)
- Opioid requirement (frequency, morphine equivalent dose) as measured by daily OMDQ(Up to 12 months)
- Impact of OM on the ability to swallow, drink, eat, talk, and sleep, as assessed by the MTS-AL(Up to 12 months)
- Quality of life as assessed by the FACT-HN(Up to 12 months)
- DFS at 12 months after treatment(at 12 months)
研究者
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