Bacterial Cellulose-monolaurin Hydrogel for Preventing Therapy-induced High-grade Acute Dermatitis Among Filipinos With Breast Adenocarcinoma: a Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Incidence of high grade acute radiation dermatitis
研究概览
简要总结
Acute radiation dermatitis (ARD) is almost universally experienced by patients with cancer during or after radiation therapy. This condition potentially leads to detrimental clinical outcomes as it adversely affects adherence to prescribed subsequent management and further worsens quality of life. Nevertheless, there remains no consensus on the appropriate intervention for ARD. This pilot two parallel-group randomized trial aims to clinically assess the potential of bacterial cellulose-monolaurin hydrogel, compared to placebo cream, to prevent high-grade ARD among Filipinos with breast cancer up to four weeks after last radiotherapy session.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female sex at birth
- •Age at least 18 years at the time of invitation
- •Eastern Cooperative Oncology Group (ECOG) Performance Status score of either 0 or 1
- •With histopathologic diagnosis of breast carcinoma
- •Already completed prescribed mastectomy and chemotherapy (adjuvant or neoadjuvant) interventions
- •Scheduled to receive hypo fractionated postmastectomy-postchemotherapy radiation therapy
排除标准
- •Pregnant or lactating
- •With concurrent or previous history of any malignancy
- •With history of mediastinal or thoracic irradiation
- •With current bilateral synchronous breast carcinoma
- •With diagnosis of metastases from any form of breast cancer
- •With any skin lesion in the planned radiation field deemed deramtologically and/or radiotherapeutically relevant
- •With concomitant disease states deemed clinically significant (connective tissue diseases, infections, uncontrolled chronic disorders, renal failure, hepatic dysfunction, etc.)
- •With known history of hypersensitivities and/or reactions against any component of either experimental or comparator interventions
- •Inability to personally provide informed consent or to personally comply with skin care instructions
研究组 & 干预措施
Experimental arm
Application of bacterial cellulose-monolaurin hydrogel in the prescribed area for every 12 hours starting from receipt of first radiotherapy until development of moist desquamation or two week after completion of radiotherapy plan
干预措施: Bacterial cellulose-monolaurin hydrogel (Other)
Placebo Arm
Application of placebo cream in the prescribed area for every 12 hours starting from receipt of first radiotherapy until development of moist desquamation or two week after completion of radiotherapy plan
干预措施: Placebo cream (Other)
结局指标
主要结局
Incidence of high grade acute radiation dermatitis
时间窗: Baseline to Week 4 post-radiotherapy
High-grade acute radiation dermatitis is defined as Common Terminology Criteria for Adverse Events (CTCAE) grade of at least 3
次要结局
- Distribution of participants in terms of ARD CTCAE grades(Baseline to Week 4 post-radiotherapy)
- Patient-reported quality of life(Baseline to Week 4 post-radiotherapy)