A Randomized, Double-Blind Pilot Study of N-Acetylcysteine Mucoadherent Rinse Versus Placebo for Thickened Secretions and Mucositis Secondary to Chemoradiotherapy in the Management of Head and Neck Malignancies
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 34
- 试验地点
- 5
- 主要终点
- Groningen Radiotherapy-Induced Xerostomia (GRIX) Sticky Saliva Total Score Area Under the Curve (AUC)
研究概览
简要总结
This randomized pilot clinical trial studies whether acetylcysteine oral rinse will lessen saliva thickness and painful mouth sores in patients with head and neck cancer undergoing radiation therapy. Side effects from radiation therapy to the head and neck, such as thickened saliva and mouth sores, may interfere with activities of daily living such as eating and drinking, and may also cause treatment to be stopped or delayed. Acetylcysteine rinse may reduce saliva thickness and mouth sores, and improve quality of life in patients with head and neck cancer undergoing radiation therapy.
详细描述
PRIMARY OBJECTIVES:
I. To determine the effectiveness of N-acetylcysteine (acetylcysteine) in improving saliva viscosity (as measured by the Groningen Radiotherapy-Induced Xerostomia [GRIX]) in patients undergoing chemotherapy and radiotherapy for head and neck cancer.
SECONDARY OBJECTIVES:
I. To determine whether N-acetylcysteine (NAC) can improve other GRIX subscale for patients undergoing chemotherapy and radiotherapy for head and neck cancer.
II. To determine whether NAC can improve patient reported quality of life as measured by the European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire (QLQ) Head & Neck (H&N)35.
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
- •Histological confirmation of tumor of the oral cavity, oropharynx, supraglottic larynx, or nasopharynx
- •Receiving concurrent chemoradiotherapy/chemobiotherapy to a minimum dose equivalent to 60 Gy in 30 fractions in the adjuvant or definitive setting
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
- •Initiation of investigational agent =< 3 days after initiation of radiotherapy
- •Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only
- •Ability to complete questionnaire(s) by themselves or with assistance
- •Provide informed written consent
- •Willing to return mail-in questionnaires during the observation phase of the study
排除标准
- •Any of the following:
- •Pregnant women
- •Nursing women
- •Men or women of childbearing potential who are unwilling to employ adequate contraception
- •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
- •Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy; NOTE: patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- •Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
- •History of myocardial infarction =< 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
- •Receipt of induction chemotherapy
- •Previous receipt of head and neck irradiation
- •Utilization of amifostine during radiotherapy
- •Greater than or equal to grade 2 dry mouth prior to chemoradiotherapy or greater than or equal to grade 2 mucositis
- •Previous intolerance/adverse effect/allergy to any component of the placebo or active agent
- •History of Sjogren's, lupus or scleroderma
研究组 & 干预措施
Arm I (acetylcysteine)
Patients receive acetylcysteine oral rinse and gargle or swish for 60 seconds then spit 5 times per day beginning within 3 days of the initiation of radiotherapy to 14 days following completion of radiotherapy.
干预措施: acetylcysteine (Drug)
Arm I (acetylcysteine)
Patients receive acetylcysteine oral rinse and gargle or swish for 60 seconds then spit 5 times per day beginning within 3 days of the initiation of radiotherapy to 14 days following completion of radiotherapy.
干预措施: quality-of-life assessment (Other)
Arm I (acetylcysteine)
Patients receive acetylcysteine oral rinse and gargle or swish for 60 seconds then spit 5 times per day beginning within 3 days of the initiation of radiotherapy to 14 days following completion of radiotherapy.
干预措施: questionnaire administration (Other)
Arm II (placebo)
Patients receive a placebo oral rinse and gargle or swish for 60 seconds and then spit 5 times per day beginning within 3 days of the initiation of radiotherapy to 14 days following completion of radiotherapy.
干预措施: placebo (Other)
Arm II (placebo)
Patients receive a placebo oral rinse and gargle or swish for 60 seconds and then spit 5 times per day beginning within 3 days of the initiation of radiotherapy to 14 days following completion of radiotherapy.
干预措施: quality-of-life assessment (Other)
Arm II (placebo)
Patients receive a placebo oral rinse and gargle or swish for 60 seconds and then spit 5 times per day beginning within 3 days of the initiation of radiotherapy to 14 days following completion of radiotherapy.
干预措施: questionnaire administration (Other)
结局指标
主要结局
Groningen Radiotherapy-Induced Xerostomia (GRIX) Sticky Saliva Total Score Area Under the Curve (AUC)
时间窗: Up to 2 weeks following radiotherapy
Groningen Radiotherapy-Induced Xerostomia (GRIX) sticky saliva total score Area under the curve (AUC).The GRIX questionnaire is a 14-item questionnaire with four subscales on 0-100 scales with higher scores representing worse symptoms. The aAUCpa for each subscale is calculated as the average of each AUC between each sequential assessment from treatment-initiation to the end of radiotherapy. For example; for each patient and each subscale, the subscale values at treatment-initiation and assessment-1 are used to calculate an Area Under the Curve (AUC) for that assessment time-period. Then these AUCs for all available assessment time-periods up to the end of their radiotherapy are averaged to yield the aAUCpa per patient per subscale. AUC will be calculated for each patient from baseline to two weeks following radiotherapy. The AUC values will be compared between the two arms using t-test (equal variance).
次要结局
- Groningen Radiotherapy-Induced Xerostomia (GRIX) Sticky Saliva Nighttime Area Under the Curve (AUC).(Up to 90 days after completion of radiation therapy)
- GRIX Xerostomia Daytime AUC(Up to 90 days after completion of radiation therapy)
- EORTC Quality of Life Questionnaire (QLQ) H&N Pain AUC(Up to 90 days after completion of radiation therapy)
- Groningen Radiotherapy-Induced Xerostomia (GRIX) Sticky Saliva Daytime Area Under the Curve (AUC)(Up to 90 days after completion of radiation therapy)
- GRIX Xerostomia Nighttime AUC(Up to 90 days after completion of radiation therapy)
- EORTC Quality of Life Questionnaire (QLQ) Swallowing(Up to 90 days after completion of radiation therapy)
- EORTC Quality of Life Questionnaire (QLQ) H&N Sticky Saliva AUC(Up to 90 days after completion of radiation therapy)
- Adverse Event, as Measured by the Number of Patients With a Maximum Grade of Any Adverse Event(Up to 90 days after completion of radiation therapy)
- GRIX Xerostiomia Total Score AUC(Up to 90 days after completion of radiation therapy)