Management of Mucositis With GM-CSF (Sargramostim) Mouthwash Study Protocol
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Marilyn Dodd
- 入组人数
- 91
- 试验地点
- 1
- 主要终点
- Comparison of Number of Participants With Grade 1 or 2 Oral Mucositis (GM-CSF and SS Groups Only)
研究概览
简要总结
GM-CSF may protect normal cells from the side effects, such as mucositis, of radiation therapy and may help damaged tissue heal faster after radiation therapy. This randomized clinical trial is studying how well GM-CSF works in preventing and treating mucositis in patients who are undergoing radiation therapy for head and neck cancer.
详细描述
OBJECTIVES:
Primary
- Compare the incidence of radiotherapy (RT)-induced oral mucositis of any grade, using the Radiation Therapy Oncology Group Acute Radiation Morbidity Scoring Criteria (RTOG ARMSC)-Mucous Membrane, in patients treated with 1 of 2 mouthwashes (sargramostim [GM-CSF] or salt and soda). (prevention portion of the study)
- Compare the effectiveness of the 2 mouthwashes in treating oral mucositis as defined by the incidence of RTOG ARMSC-Mucous Membrane grade 3 and 4 mucositis in patients in 1 of 3 groups (salt and soda, continuing GM-CSF, or new GM-CSF). (treatment portion of the study)
Secondary
- Compare the effectiveness of the 2 mouthwashes in preventing RT-induced oral mucositis by the following direct indices:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Histopathologically confirmed diagnosis of head and neck cancer
- •Scheduled to undergo continuous course of conventional or hyperfractionated radiotherapy or intensity-modulated radiotherapy (IMRT) with or without concurrent chemotherapy
- •Planning to receive a total radiation dose ≥ 5,500 centigray (cGy), administered in a single daily fraction of 180-220 cGy (5 days a week) or twice daily fractions of 110-150 cGy
- •Normal baseline oral examinations (no pre-existing lesion)
- •Karnofsky performance status 60-100%
- •Mentally capable of participating in research protocol
- •Expected survival > 4.5 months
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Creatinine ≤ 2.0 mg/dL
- •Bilirubin ≤ 2.0 mg/dL
- •Aspartate aminotransferase (AST) < 5 times upper limit of normal
- •HIV negative
排除标准
- •No unresolved adverse event from previous therapy
- •No prior radiotherapy to the head and neck
- •No prior or concurrent brachytherapy
- •No prior participation in this study
- •No T1 or T2 glottic tumors
- •No other serious concurrent medical illness
- •No history of insulin-dependent diabetes mellitus
- •No prior hypersensitivity reaction to yeast material
- •No recent history of oral ulceration, herpes simplex, oral candidiasis, severe gingivitis, active or chronic mucositis, or xerostomia
- •No current New York Heart Association class II-IV congestive heart failure
- •Not pregnant or nursing
- •No chemotherapy, radiotherapy, or other investigational drugs within the past 4 weeks
- •No major surgery within the past 2 weeks
- •No systemic sargramostim (GM-CSF) within the past 7 days
- •No systemic filgrastim (G-CSF) within the past 24 hours
- •No systemic long-acting pegfilgrastim within the past 14 days
- •No antibiotics, antifungals, or antivirals for oral conditions at baseline
- •No other concurrent chemotherapy agent
- •No concurrent enrollment on other head and neck studies
- •No other concurrent investigational drugs
- •No concurrent administration of any of the following:
- •"Magic or miracle mouthwash" containing a palliative mixture of topical anesthetics/analgesics, coating agents, and other medications without an approved indication for topical oral use except liquid antacid formulations (e.g., Maalox® or Mylanta® or their generic equivalents)
- •Other concurrent over-the-counter or prescription mouthwashes beyond the systematic oral care protocol provided by the study or any other drugs or agents to aid in oral hygiene (e.g., chlorhexidine, gluconate, pilocarpine, amifostine, sucralfate tablets or slurry, or benzydamine)
- •Use of corticosteroids for chronic conditions OR within the past 7 days
研究组 & 干预措施
Arm II: Salt & Soda Group (SS)
Arm II: Patients were randomized to receive salt and soda (SS) mouthwash as a prevention, holding it in their mouths and swallowing it in intervals over 1 hour once daily. If they develop mucositis, they continue receiving SS treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
干预措施: oral salt and soda mouthwash (Other)
Arm III: Salt & Soda Switched to GM-CSF (SG)
Arm III: Patients were randomized to receive oral salt and soda (SS) mouthwash as a prevention, holding it in their mouths and swallowing it in intervals over 1 hour once daily. If they develop mucositis, they continue receiving GM-CSF treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
干预措施: oral salt and soda mouthwash (Other)
Arm III: Salt & Soda Switched to GM-CSF (SG)
Arm III: Patients were randomized to receive oral salt and soda (SS) mouthwash as a prevention, holding it in their mouths and swallowing it in intervals over 1 hour once daily. If they develop mucositis, they continue receiving GM-CSF treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
干预措施: sargramostim (Biological)
Arm I: GM-CSF Group (GG)
Arm I: Patients were randomized to receive oral sargramostim (GM-CSF) mouthwash as a prevention, holding it in their mouths and swallowing it in intervals over 1 hour once daily. If they develop mucositis, they continue receiving GM-CSF treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
干预措施: sargramostim (Biological)
结局指标
主要结局
Comparison of Number of Participants With Grade 1 or 2 Oral Mucositis (GM-CSF and SS Groups Only)
时间窗: From baseline to onset of mucositis, approximately 16 days
The number of participants with recorded grade 1 (mild; Irritation, may experience slight pain, not requiring analgesic) or grade 2 (moderate; Patchy mucositis that may produce inflammatory serosanguinitis discharge; may experience moderate pain requiring analgesia) oral mucositis using the Radiation Therapy Oncology Group (RTOG) Acute Radiation Morbidity Scoring Criteria Oral Mucosa Assessment Scale at baseline and during radiotherapy will be recorded. The RTOG grading is reliant on a clinician's ability to judge the anatomical changes associated with oral mucositis (size and characteristics of ulceration), with symptoms ranging from Grade 0 (no symptoms) to Grade 4 (Ulceration, hemorrhage, or necrosis). A comparison of incidence in the GM-CSF Group (GG) and Arm II: Salt \& Soda Group (SS) will be reported.
Comparison of the Mean Number of Days for Mucositis to Heal Across by Group
时间窗: From onset of mucositis to healing of mucositis, approximately 80 days
The mean number of days for mucositis to heal will be used to evaluate the effectiveness of the two mouthwashes in treating oral mucositis as defined by the incidence of Radiation Therapy Oncology Group Acute Radiation Morbidity Scoring.
次要结局
- Comparison of Combined Mean Score on the Pain Questionnaire by Group(Up to 3 months)
- Comparison of Combined Mean Score on the Karnofsky Performance Status Scale (KPS) by Group(Up to 3 months)
- Comparison of the Combined Mean Score on the Overall Quality of Life Questionnaires by Group(Up to 3 months)
研究者
Marilyn Dodd
Principal Investigator
University of California, San Francisco