Comparison of best supportive care with or without topical autologous platelet rich plasma as a prophylactic agent for reducing acute radiation dermatitis: a randomized controlled study.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- To determine if the proportion of patients developing acute radiation dermatitis of Radiation Therapy Oncology Group (RTOG) grade 2 and above is lesser in the platelet rich plasma arm as compared to the standard treatment arm in patients undergoing radiation therapy for head and neck and breast cancer.
研究概览
简要总结
More than 90% of head and neck and breast cancer patients require radiotherapy either in the definitive, adjuvant or palliative setting. Radiation dermatitis leads to significant distress to the patient due to the pain and burning sensation and can greatly impair the patient’s quality of life. It may further get complicated by superadded infections on the raw surface and can quickly turn into sepsis due to the breach of the protective barrier of the skin. In severe cases it can also result in interruptions to treatment and prolongation of treatment time which can have detrimental effects on the local control of the disease and can affect the treatment outcomes. There is currently no literature available on the prophylactic potential of autologous platelet-rich plasma in reducing the incidence of acute radiation dermatitis in patients with head and neck and breast cancer. This study aims to address this gap in the body of evidence and contribute to our understanding of this topic. This study may provide a safe, cost-effective solution to reduce radiation dermatitis in head and neck and breast cancer patients, while also advancing our knowledge of the role of autologous platelet-rich plasma in mitigating radiation-induced complications, guiding further research possibilities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients over 18 years of age.
- •Patients of ECOG performance status 0-2
- •Patients with biopsy proven squamous cell carcinoma of the head and neck, receiving curative radiation with or without concurrent chemotherapy in the definitive or adjuvant setting.
- •Patients with biopsy proven adenocarcinoma of the breast, post-surgical resection (either breast conservative surgery or modified radical mastectomy) who are receiving curative radiation in the adjuvant setting.
排除标准
- •Patients receiving palliative radiation
- •Patients with prior history of radiation to the head and neck or breast
- •Patients with tumor involving the skin
- •Patients with rash, ulceration or open wounds in the treatment field.
- •Patients too sick to withstand a blood withdrawal of more than 100 ml e.g., those with multiple comorbidities like cardiac diseases, respiratory diseases etc (to be decided by the clinical judgment of the physician in the Blood bank/ Transfusion medicine center ).
结局指标
主要结局
To determine if the proportion of patients developing acute radiation dermatitis of Radiation Therapy Oncology Group (RTOG) grade 2 and above is lesser in the platelet rich plasma arm as compared to the standard treatment arm in patients undergoing radiation therapy for head and neck and breast cancer.
时间窗: Weekly during the course of radiation treatment and 3 months after the completion of radiation treatment.
次要结局
- To compare the locoregional control assessed with complete response of the primary and regional nodes at 3 months in both the arms. This will be done by a CECT scan in head and neck cancer patients using the RECIST (Response Evaluation Criteria In Solid Tumors) criteria and by clinical examination in breast cancer patients.(3 months after the completion of radiation treatment.)
- To determine if the proportion of patients developing clinically significant acute radiation dermatitis of RTOG grade 3 and above is lesser in the PRP arm as compared to the standard treatment arm.(Weekly during the course of radiation treatment and 3 months after the completion of radiation treatment.)
- To determine if the time taken to develop Radiation Therapy Oncology Group (RTOG) grade 2,3 or 4 dermatitis is more in the PRP arm as compared to the standard treatment arm.(Weekly during the course of radiation treatment and 3 months after the completion of radiation treatment.)
研究者
Dr Ebenezer Staines
Jawaharlal Institute of Post Graduate Medical Education and Research, JIPMER