NCT07553260Not yet recruiting
Effectiveness of 0.9% Normal Saline Soaking in Managing Acute Radiation Dermatitis
The Effectiveness of Saline Soaks in Managing Acute Radiation Dermatitis
Source: ClinicalTrials.gov · Last updated 27 Apr 2026
Brief summary (registry, in English)
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
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- First submitted
- 20 Apr 2026
- Start date
- May 2026
- Primary completion date
- May 2027
- Lead sponsor
- King Hussein Cancer Center
- Diseases
- Head and neck cancer, Sarcoma
- NCT number
- NCT07553260
What you commit to
- Study type: Interventional
- Planned participants: 150
- From May 2026 to the primary completion date, May 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients receiving palliative radiotherapy
- Previous radiotherapy to the same treatment field
Other illness
- Known pre-existing skin disorders affecting radiation area (e.g., systemic lupus erythematosus, scleroderma)
- Any condition that, in the investigator's judgment, may interfere with participation or wound healing assessment
Other
- ECOG performance status ≥2
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| King Hussien Cancer Center Coordinator of this site? Confirm its status | Amman | Jordan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.