A Randomized, Prospective, Multi-center Trial to Assess the Efficacy of a Cryotherapy Device Versus Best Supportive Oral Care in Mitigating Symptoms of Oral Mucositis in Patients Receiving Chemotherapy for the Treatment of Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 176
- 试验地点
- 20
- 主要终点
- The incidence of oral mucositis symptomatic events observed during the first cycle of chemotherapy.
研究概览
简要总结
This study will compare the use of the Chemo MouthpieceTM device along with best supportive oral care to best supportive oral care alone to rate the effectiveness of Chemo MouthpieceTM in lessening symptoms associated with chemotherapy regimen known to place patients at risk for symptomatic mucositis and, of those, chemotherapy regimens for which ice-based cryotherapy has been demonstrated to have a favorable impact on oral mucositis symptom management. Subjects who are receiving standard chemotherapy regimens will be randomly assigned to receive either study device and oral care ingredients or oral care ingredients only. All subjects will complete daily diaries for the first 14 days of chemotherapy Cycles 1 and 2. Subjects who are assigned to the study device arm will use the device during their chemotherapy infusion in clinic and will continue to use the device at home ,at least twice daily, for the first six (6) days of chemotherapy Cycles 1 and 2. Prior to the first chemotherapy infusion in Cycle 3, all subjects in the study regardless of treatment assignment will have the option of using the Chemo MouthpieceTM for subsequent cycles.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-80 years
- •Planned to receive at least 2 cycles of infused stomatotoxic chemotherapy regimens such as:
- •CMF (cyclophosphamide (Cytoxan), methotrexate, 5-FU)
- •Standard AC+T regimen (doxorubicin (Adriamycin), cyclophosphamide (Cytoxan), Taxane [paclitaxel (Taxol) or docetaxel (Taxotere)]) or any combination of two or more components (e.g., ACT, TAC, TA, AT, AC)
- •ABVD (doxorubicin (Adriamycin), bleomycin, vinblastine, dacarbazine)
- •FOLFIRI (irinotecan, 5-FU, leucovorin)
- •Any other 5-FU-based regimen (excluding FOLFOX)
- •Be willing and able to complete all study-related activities
- •Properly obtained written informed consent
排除标准
- •Receiving any oxaliplatin-containing chemotherapy regimen, such as FOLFOX
- •Concurrent radiotherapy
- •Unable or unwilling to complete study assessments
- •Unable or unwilling to avoid using ice chips
- •Known allergy to silicone
- •Concurrent participation in another interventional clinical study or use of another investigational agent within 30 days prior to randomization
- •Any other clinical or psychiatric condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study or unable to comply with the protocol
- •Chronic use of opioid analgesics
结局指标
主要结局
The incidence of oral mucositis symptomatic events observed during the first cycle of chemotherapy.
时间窗: Cycle 1 of chemotherapy (14-28 days, time frame varies based on regimen)
The presence and severity of oral mucositis symptoms will be measured by patient self-report using the Oral Mucositis Symptom Assessment scale with positive symptoms defined as a score of 1 or greater and severe symptoms defined as a score of 2 or greater.
The incidence of oral mucositis symptomatic events observed during the second cycle of chemotherapy.
时间窗: Cycle 2 of chemotherapy (14-28 days, time frame varies based on regimen)
The presence and severity of oral mucositis symptoms will be measured by patient self-report using the Oral Mucositis Symptom Assessment scale with positive symptoms defined as a score of 1 or greater and severe symptoms defined as a score of 2 or greater.
The incidence of severe oral mucositis symptomatic events observed during the second cycle of chemotherapy.
时间窗: Cycle 2 of chemotherapy (14-28 days, time frame varies based on regimen)
The presence and severity of oral mucositis symptoms will be measured by patient self-report using the Oral Mucositis Symptom Assessment scale with positive symptoms defined as a score of 1 or greater and severe symptoms defined as a score of 2 or greater.
The incidence of severe oral mucositis symptomatic events observed during the first cycle of chemotherapy.
时间窗: Cycle 1 of chemotherapy (14-28 days, time frame varies based on regimen)
The presence and severity of oral mucositis symptoms will be measured by patient self-report using the Oral Mucositis Symptom Assessment scale with positive symptoms defined as a score of 1 or greater and severe symptoms defined as a score of 2 or greater.
次要结局
- Incidence and severity of oral mucositis symptoms per chemotherapy cycle(Cycle 2 of chemotherapy (14-28 days, time frame varies based on regimen))
- Duration of oral mucositis symptoms(Cycle 2 of chemotherapy (14-28 days, time frame varies based on regimen))
- Percent of days the Chemo MouthpieceTM was used(Cycle 2 of chemotherapy (14-28 days, time frame varies based on regimen))
- Ease of use of the Chemo MouthpieceTM based on patient-reported Chemo Mouthpiece End of Study Device Assessment(Cycle 2 of chemotherapy (14-28 days, time frame varies based on regimen))
- Analgesic use to control mouth pain(Cycle 2 of chemotherapy (14-28 days, time frame varies based on regimen))