Phase II Randomized Trial of Prophylactic Manuka Honey for the Reduction of Chemoradiation Therapy Induced Esophagitis-Related Pain During the Treatment of Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 163
- 试验地点
- 59
- 主要终点
- Change in Radiation Esophagitis-related Pain at 4 Weeks as Measured by the Numerical Rating Pain Scale for Pain on Swallowing (NRPS)
研究概览
简要总结
RATIONALE: Manuka honey may prevent or reduce esophagitis-related pain caused by chemotherapy and radiation therapy. It is not yet known whether Manuka honey is more effective than standard care in preventing pain.
PURPOSE: This randomized phase II clinical trial is studying Manuka honey to see how well it works in preventing esophagitis-related pain in patients receiving chemotherapy and radiation therapy for lung cancer.
详细描述
OBJECTIVES:
Primary
- Evaluate the relative efficacy of 4 times a day consumption of liquid or lozenge Manuka honey to delay or prevent radiation esophagitis-related pain (during combined chemotherapy and radiation therapy for lung cancer) as compared to standard supportive treatment, as measured at week 4 by Numerical Rating Pain Scale (NRPS) for pain upon swallowing.
Secondary
- Evaluate the trend of severity of radiation esophagitis-related pain during combined chemotherapy and radiation therapy for lung cancer using weekly measurements of the NRPS.
- Evaluate the adverse events associated with Manuka honey, as measured by CTCAE, v. 4.
- Evaluate the severity of radiation esophagitis (grade 3-4, CTCAE, v. 4).
- Assess weight loss (percent weight change from baseline to 4 weeks).
- Assess quality of life (QOL) and pain, as measured by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-30) global QOL score and pain symptom subscale.
- Assess patient-reported dysphagia via a daily patient log.
- Assess nutritional status, as measured by the mean change in serum prealbumin levels from baseline to 4 weeks.
- Assess opioid use by collecting the patient's narcotic use in the previous 24-hour period at each weekly evaluation.
- Evaluate patient-reported adverse events associated with Manuka honey using the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Supportive Care
Standard supportive care
干预措施: Standard supportive care (Drug)
Liquid Manuka Honey
Manuka honey in liquid form
干预措施: Manuka honey in liquid form (Drug)
Lozenge Manuka Honey
Manuka honey in lozenge form
干预措施: Manuka honey in lozenge form (Drug)
结局指标
主要结局
Change in Radiation Esophagitis-related Pain at 4 Weeks as Measured by the Numerical Rating Pain Scale for Pain on Swallowing (NRPS)
时间窗: Baseline and 4 weeks from the start of treatment
Esophagitis-related pain was measured using patient-reported pain on swallowing as assessed by the Numerical Rating Pain Scale (NRPS), an 11-point scale (0-10) in which 0 indicates no pain and 10 indicates the worst pain imaginable. Generally, scores of 1-4 indicate mild pain, scores of 5-6 indicate moderate pain, and scores of 7-10 indicate severe pain. Change was calculated by subtracting the baseline value from the 4-week value. The experimental arms (honey) were compared to the standard arm (supportive care).
次要结局
- Quality of Life and Pain, as Measured by the EORTC QLQ-30 Global QOL Score and Pain Symptom Subscale at 4 and 12 Weeks(Baseline, 4 and 12 weeks from the start of treatment)
- Nutritional Status (Change in Serum Prealbumin Levels From Baseline to 4 Weeks)(Baseline and 4 weeks from the start of treatment)
- Percentage of Patients Using Opioids(Baseline, 4 weeks, end of radiation treatment, and 12 weeks from the start of treatment)
- Radiation Esophagitis-related Pain During Treatment as Measured During Treatment and 12 Weeks by the Numerical Rating Pain Scale (NRPS)(Baseline, weekly during treatment, and 12 weeks from the start of treatment)
- Dysphagia Via Daily Patient Log(Weekly during treatment and 12 weeks from the start of treatment)
- Percentage of Participants With Radiation Esophagitis Grade 3-4 (CTCAE v. 4)(Up to 12 weeks from the start of treatment)
- Percent Change in Weight From Baseline to 4 Weeks(Baseline and 4 weeks from the start of treatment)
- Adverse Events Associated With Manuka Honey Using CTCAE v4.0(Until 12 weeks from the start of treatment)
- Patient Reported Difficulty in Swallowing Associated With Manuka Honey Using the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)(Baseline and 4 weeks from the start of treatment)