The Effectiveness of Saline Soaks in Managing Acute Radiation Dermatitis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Incidence of Grade II or Higher Acute Radiation Dermatitis
研究概览
简要总结
The goal of this clinical trial is to learn if normal saline soaks can reduce the severity of acute radiation dermatitis in patients with sarcomas or head and neck cancer receiving radiotherapy. It will also learn if saline soaks can improve wound healing and reduce treatment interruptions caused by skin toxicity. The main questions it aims to answer are:
- Does the application of normal saline soaks reduce the severity of acute radiation dermatitis according to CTCAE Version 5.0?
- Does the use of normal saline soaks improve wound healing time and reduce the frequency and duration of radiotherapy interruptions? Researchers will compare standard care plus saline soaks (intervention group) to standard care alone (control group) to see if saline soaks reduce skin reaction severity and improve clinical outcomes.
Participants will:
- Be randomly assigned to receive either standard care alone or standard care with daily saline soaks
- Apply saline-soaked gauze to the affected radiation area for 5-10 minutes once daily (intervention group only)
- Attend weekly clinic visits for skin assessment during radiotherapy
- Be assessed for skin reaction severity, wound healing, and treatment interruptions at baseline, after 4 weeks, and 2 weeks after completing treatment
详细描述
Radiotherapy is a cornerstone in the management of many malignancies, including sarcomas and head and neck cancers. Despite its therapeutic benefits, radiation-induced skin reactions remain one of the most common adverse effects, with the majority of patients developing some degree of acute radiation dermatitis (ARD). These reactions range from mild erythema to severe moist desquamation, which can lead to pain, increased risk of infection, impaired quality of life, and potential interruptions in treatment delivery. Such interruptions may negatively impact treatment efficacy and overall clinical outcomes.
Supportive skin care during radiotherapy is therefore essential. Current management strategies include general skin care measures, topical corticosteroids, moisturizers, and advanced wound dressings. However, there is no universally accepted standard intervention for preventing or managing ARD, and practices often vary across institutions.
Normal saline (0.9% sodium chloride) soaks are widely used in clinical settings as a supportive, non-pharmacological intervention for managing skin reactions. Saline soaks are believed to cleanse the affected area, soften crusted tissue, reduce surface bacterial load, and maintain a moist wound environment that supports re-epithelialization. In addition, they are low-cost, easy to administer, and suitable for home use, making them an attractive option for routine supportive care. Despite their frequent inclusion in clinical practice guidelines and institutional protocols, there is limited high-quality evidence specifically evaluating their independent effectiveness in reducing the severity of ARD.
This study is designed as an open-label, randomized clinical trial to evaluate the effectiveness of standardized normal saline soaks when used in addition to standard skin care in patients undergoing radiotherapy for sarcomas or head and neck cancers. Participants will be randomly assigned in a 1:1 ratio to receive either standard care alone or standard care plus saline soaks. Randomization will be conducted using a computer-generated sequence to ensure balanced group allocation.
The intervention consists of applying sterile gauze soaked in room-temperature normal saline (0.9% NaCl) to the irradiated skin area for a short duration on a daily basis. The procedure will be demonstrated by trained nursing staff in the clinical setting, and participants will be instructed on proper technique for safe and consistent application at home. Adherence to the intervention will be reinforced خلال follow-up visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Age ≥ 18 years
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- •Patients receiving definitive radiotherapy for sarcomas or head and neck cancer (primary or postoperative treatment)
- •Planned radiation dose between 60-70 Gy according to disease-specific protocols
- •No prior history of malignancy other than sarcomas
- •Ability and willingness to comply with study procedures (>90% expected adherence)
- •Signed informed consent
排除标准
- •Patients receiving palliative radiotherapy
- •Known pre-existing skin disorders affecting radiation area (e.g., systemic lupus erythematosus, scleroderma)
- •ECOG performance status ≥2
- •Previous radiotherapy to the same treatment field
- •Any condition that, in the investigator's judgment, may interfere with participation or wound healing assessment
研究组 & 干预措施
Standard Care plus Normal Saline Soaks (Intervention Group)
Participants in this arm will receive standard care in addition to daily normal saline soaks. The intervention consists of applying sterile gauze soaked in room-temperature 0.9% sodium chloride solution to the irradiated skin area for 5-10 minutes once daily. Participants will be trained in clinic and will continue home application throughout the radiotherapy course under routine follow-up.
干预措施: Normal Saline Soaks (0.9% Sodium Chloride) (Other)
结局指标
主要结局
Incidence of Grade II or Higher Acute Radiation Dermatitis
时间窗: During radiotherapy treatment period (approximately 6-7 weeks)
The primary outcome is the proportion of patients who develop Grade II or higher acute radiation dermatitis, assessed using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 during the course of radiotherapy.
次要结局
- Time to Wound Healing of Radiation-Induced Skin Reactions(From onset of skin reaction until complete epithelialization (up to 8 weeks))
- Frequency and Duration of Radiotherapy Interruptions Due to Skin Toxicity(During the full course of radiotherapy (approximately 6-7 weeks))
