Effectiveness of 0.9% Normal Saline Soaking in Managing Acute Radiation Dermatitis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKing Hussein Cancer Center
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Normal Saline Soaks (0.9% Sodium Chloride)
Other interventionParticipants 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.
Treatment groups
150 Participants
are divided into 1 treatment groupGroup A: Standard Care plus Normal Saline Soaks (Intervention Group)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of Grade II or Higher Acute Radiation Dermatitis
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.
Time frame
During radiotherapy treatment period (approximately 6-7 weeks)Secondary outcomes
1
Time to Wound Healing of Radiation-Induced Skin Reactions
This outcome measures the duration required for complete healing of radiation-induced skin reactions, defined as full re-epithelialization of the affected skin area without exudate or open wound.
Time frame
From onset of skin reaction until complete epithelialization (up to 8 weeks)2
Frequency and Duration of Radiotherapy Interruptions Due to Skin Toxicity
This outcome assesses the number and total duration of unplanned radiotherapy treatment interruptions caused by acute radiation dermatitis or related skin toxicity.
Time frame
During the full course of radiotherapy (approximately 6-7 weeks)Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: