Effectiveness of 0.9% Normal Saline Soaking in Managing Acute Radiation Dermatitis (NCT07553260) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Effectiveness of 0.9% Normal Saline Soaking in Managing Acute Radiation Dermatitis
Jordan150 participantsStarted 2026-05
Plain-language summary
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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Grade II or Higher Acute Radiation Dermatitis
Timeframe: During radiotherapy treatment period (approximately 6-7 weeks)