Randomized Controlled Trial Comparing 4 Intervention Arms, Including 3 Different Concentrations of Methylene Blue Oral Rinse Combined With Conventional Therapy and Conventional Therapy, in Patients With Intractable Pain Associated With Oral Mucositis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Change in Pain Scores Assessed Within the Numeric Rating Scale (NRS) Component of the Modified Harris Mucositis-related Pain Assessment Tool
研究概览
简要总结
This phase II trial studies how well methylene blue works in treating patients with cancer and pain associated with oral mucositis. Methylene blue may relieve pain associated with oral mucositis.
详细描述
PRIMARY OBJECTIVES:
I. To evaluate the efficacy of methylene blue (MB) in reducing the severity of mucositis-related pain, measured by numeric rating scale (NRS), in cancer patients who underwent or are undergoing chemotherapy or radiation therapy.
OUTLINE: Patients are randomized to 1 of 4 groups.
GROUP 1: Patients receive lower dose methylene blue orally (PO) to swish and spit for 5 minutes every 6 hours then receive standard of care therapy.
GROUP 2: Patients receive medium dose methylene blue PO to swish and spit for 5 minutes every 6 hours then receive standard of care therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Patients with a cancer diagnosis, receiving chemotherapy, radiation therapy or the combination
- •Patients with a current diagnosis of oral mucositis
- •Patients with pain and oral dysfunction associated with oral mucositis despite conventional therapy
- •Voluntary written consent
- •Patient must agree to use of contraception or abstinence from sex during the treatment period and for 30 days after patient's last dose
排除标准
- •Patients with known allergy to MB
- •Patients taking medications with known significant drug interactions
- •Pregnant or lactating patients
- •Patients who are cognitively impaired and unable to consent for the study
- •Patients with risk of broncho-aspiration based on documented swallowing test by a speech pathologist (if available)
- •Patients with known history of G6PD deficiency
- •Patients undergoing any other experimental intervention for oral mucositis
- •Patients who have no pain or impairment in oral function, patients who are not symptomatic
- •Patients with head and neck cancer
- •Patients on serotonergic drugs
研究组 & 干预措施
Group 1 (lower dose methylene blue, standard of care)
Patients receive lower dose methylene blue PO to swish and spit for 5 minutes every 6 hours then receive standard of care therapy.
干预措施: Methylene Blue (Drug)
Group 1 (lower dose methylene blue, standard of care)
Patients receive lower dose methylene blue PO to swish and spit for 5 minutes every 6 hours then receive standard of care therapy.
干预措施: Best Practice (Other)
Group 2 (medium dose methylene blue, standard of care)
Patients receive medium dose methylene blue PO to swish and spit for 5 minutes every 6 hours then receive standard of care therapy.
干预措施: Best Practice (Other)
Group 2 (medium dose methylene blue, standard of care)
Patients receive medium dose methylene blue PO to swish and spit for 5 minutes every 6 hours then receive standard of care therapy.
干预措施: Methylene Blue (Drug)
Group 3 (higher dose methylene blue, standard of care)
Patients receive higher dose methylene blue PO to swish and spit for 5 minutes every 6 hours then receive standard of care therapy.
干预措施: Best Practice (Other)
Group 3 (higher dose methylene blue, standard of care)
Patients receive higher dose methylene blue PO to swish and spit for 5 minutes every 6 hours then receive standard of care therapy.
干预措施: Methylene Blue (Drug)
Group 4 (standard of care)
Patients receive standard of care therapy.
干预措施: Best Practice (Other)
结局指标
主要结局
Change in Pain Scores Assessed Within the Numeric Rating Scale (NRS) Component of the Modified Harris Mucositis-related Pain Assessment Tool
时间窗: Baseline up to day 7
Oral mucositis pain reduction (measured by using the Numeric Rating Scale (NRS); from 0, representing no pain, to 10, representing the worst possible pain) from baseline to 7 days post treatment. The pain scale is included in the Modified Harris mucositis-related pain assessment tool.
次要结局
- Change in Oral Function Burden (OFB) Scores(Baseline up to day 7)
- World Health Organization Oral Mucositis Severity Grades(Up to day 2)
- Morphine Equivalent Daily Doses (MEDD)(Baseline to Day 2)
- Pain Duration(Up to 30-90 days)