Phase III Placebo-Controlled Trial to Evaluate Dexamethasone Use for Everolimus-Induced Oral Stomatitis: Prevention Versus Early Treatment Approaches: MIST (My Individualized Stomatitis Treatment)
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 39
- 试验地点
- 319
- 主要终点
- Incidence Rate of the mTOR Inhibitor-associated Stomatitis (mIAS)-Related Pain Based on Daily Self-reports Via the Numerical Analogue Scale
研究概览
简要总结
This phase III trial studies how well dexamethasone works in reducing everolimus-induced oral stomatitis in patients with cancer. Dexamethasone may help to reduce the everolimus-induced oral stomatitis so as to improve quality of life in cancer patients.
详细描述
PRIMARY OBJECTIVES:
I. To determine if the initiation of dexamethasone at the start of everolimus treatment prevents mTOR inhibitor-associated stomatitis (mIAS)-associated pain, compared to the initiation of placebo.
II. To determine if the initiation of dexamethasone at the start of everolimus treatment will be superior compared to the initiation of placebo in terms of the overall severity of mIAS-associated pain.
SECONDARY OBJECTIVES:
I. To utilize the same measurement method that was reported in the SWISH trial: A combination of a patient reported pain scale, data from a normalcy of diet questionnaire, and clinician grading of stomatitis to determine the incidence of > grade 2 mIAS.
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
- Quadruple (Participant, Care Provider, 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
- •Current cancer diagnosis, about to receive oral everolimus 10 mg/day with or without an endocrine agent. Patients about to receive everolimus for off label use for any cancer are also eligible.
- •Not currently receiving chemotherapy or any other agent known to cause mucositis or stomatitis. Trastuzumab and ovarian function suppression are allowed.
- •Any prior chemotherapy or other stomatitis/mucositis-causing therapy must be completed at least 2 weeks prior to registration.
- •Not currently suffering from stomatitis/mucositis or mouth ulcers. Patients should not have had any stomatitis or mouth pain for at least 7 days prior to registration.
- •Patients should not receive any other agent which would be considered treatment for stomatitis or impact the primary endpoint.
- •No history of candida infection (thrush) within the last 3 months.
- •Not currently being treated with corticosteroids.
- •No uncontrolled diabetes mellitus, defined by hemoglobin A1C greater than 8%, although A1C is not needed for all patients, hemoglobin (Hgb)A1C < 8 is required for everyone with diabetes or suspected diabetes.
- •Patients must be able to read and comprehend English. Local translation, including verbal translation of professionals (PROs) is not permitted.
- •Not pregnant and not nursing, because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown. Therefore, for women of childbearing potential only, a negative pregnancy test done =< 7 days prior to registration is required.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2.
排除标准
- 未提供
研究组 & 干预措施
Group I (dexamethasone)
Patients receive 10mg oral everolimus daily as standard of care and 10ml dexamethasone oral mouthwash, swished for 2-minutes daily, for 8 weeks.
干预措施: Dexamethasone (Drug)
Group I (dexamethasone)
Patients receive 10mg oral everolimus daily as standard of care and 10ml dexamethasone oral mouthwash, swished for 2-minutes daily, for 8 weeks.
干预措施: Questionnaire (Other)
Group I (dexamethasone)
Patients receive 10mg oral everolimus daily as standard of care and 10ml dexamethasone oral mouthwash, swished for 2-minutes daily, for 8 weeks.
干预措施: Quality-of-Life Assessment (Other)
Group I (dexamethasone)
Patients receive 10mg oral everolimus daily as standard of care and 10ml dexamethasone oral mouthwash, swished for 2-minutes daily, for 8 weeks.
干预措施: Everolimus (Drug)
Group II (placebo)
Patients receive 10mg oral everolimus daily as standard of care and 10ml placebo oral mouthwash, swished for 2-minutes daily, for 8 weeks.
干预措施: Placebo (Other)
Group II (placebo)
Patients receive 10mg oral everolimus daily as standard of care and 10ml placebo oral mouthwash, swished for 2-minutes daily, for 8 weeks.
干预措施: Questionnaire (Other)
Group II (placebo)
Patients receive 10mg oral everolimus daily as standard of care and 10ml placebo oral mouthwash, swished for 2-minutes daily, for 8 weeks.
干预措施: Quality-of-Life Assessment (Other)
Group II (placebo)
Patients receive 10mg oral everolimus daily as standard of care and 10ml placebo oral mouthwash, swished for 2-minutes daily, for 8 weeks.
干预措施: Everolimus (Drug)
结局指标
主要结局
Incidence Rate of the mTOR Inhibitor-associated Stomatitis (mIAS)-Related Pain Based on Daily Self-reports Via the Numerical Analogue Scale
时间窗: Up to 8 weeks
The numerical analogue mouth pain score (NAMPS) is a single item measured on a 0 to 10 scale, with 0 corresponding to "No pain" and 10 corresponding to "Pain as bad as it can be." Will compare the incidence rate of any mouth pain (i.e., any score greater than 0) as assessed by the NAMPS between the prevention versus early treatment approaches using a Chi-square test.
Severity of Mouth Pain Scores
时间窗: Up to 8 weeks
Average Area Under the Curve per assessment (aAUCpa) of mouth pain scores as measured by NAMPS will be computed for each patient to summarize the sequence of numerical analogue mouth pain scores over the eight week study period. Scores are reported on a 0-100 scale, where 100 = better outcome QOL (i.e. less pain). The aAUCpa is the average of each AUC between each sequential assessment from treatment-initiation to the end of the treatment at 8 weeks post-treatment-initiation and will be compared between the two treatment arms.
次要结局
- Incidence of Grade > 2 mIAS as Measured by the SWISH Trial(Up to 8 weeks)
- Time to Development of Mouth Pain(Up to 8 weeks)
- Sleep Level of Activity Interference With Daily Activities(Up to 8 weeks)
- Incidence of Mouth Pain(Up to 8 weeks)
- Incidence of Patients Reducing Everolimus Dose(Up to 8 weeks)
- Dexamethasone Prescription Fill Rates(Up to 8 weeks)
- Quality of Life Assessed by Linear Analogue Self-Assessment(Up to 8 weeks)
- Mouth/Throat Sore Level of Activity Interference With Daily Activities(Up to 8 weeks)
- Adherence to Everolimus Therapy Dose(Up to 8 weeks)
- Incidence of Patients Stopping Everolimus Early(Up to 8 weeks)
- Time to Dexamethasone Prescription Fill(Up to 8 weeks)
- Time to Develop Mouth Sores Per Study Arm Assessed by PRO-CTCAE Mouth/Throat Sore Item Regarding Severity(Up to 8 weeks)
- Mean Degrees of Patient-reported Mouth Sores Per Study Arm Assessed by NAMPS(Up to 8 weeks)
- Median Degree of Patient-reported Mouth Sores Per Study Arm Assessed by NAMPS(Up to 8 weeks)
- Proportion of Patients Who Experience Grade 2 Stomatitis(Up to 2 months)