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Saline soaks for skin reactions during radiotherapy in head and neck cancer or sarcoma

Tests saline skin soaks for radiation burns in adults with head and neck cancer.

Plain-language title generated from the registry record
Registry title: Effectiveness of 0.9% Normal Saline Soaking in Managing Acute Radiation Dermatitis

Key facts

Where
Amman, JordanSee the site

Where in Jordan

  • King Hussien Cancer CenterAmman, JordanNo longer taking part

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Trial details

Who runs it
King Hussein Cancer Center
Trial code
NCT07553260
Record updated
27 April 2026
Original description
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:Read full original descriptionShow less

The Effectiveness of Saline Soaks in Managing Acute Radiation Dermatitis

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

Inclusion: 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: Patients receiving palliative radiotherapy; Previous radiotherapy to the same treatment field; 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; ECOG performance status ≥2.

ClinicalTrials.gov NCT07553260