About this trial
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:
1. Does the application of normal saline soaks reduce the severity of acute radiation dermatitis according to CTCAE Version 5.0? 2. 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:
1. Be randomly assigned to receive either standard care alone or standard care with daily saline soaks 2. Apply saline-soaked gauze to the affected radiation area for 5-10 minutes once daily (intervention group only) 3. Attend weekly clinic visits for skin assessment during radiotherapy 4. Be assessed for skin reaction severity, wound healing, and treatment interruptions at baseline, after 4 weeks, and 2 weeks after completing treatment
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Normal Saline Soaks (0.9% Sodium Chloride)