Effectiveness of 0.9% Normal Saline Soaking in Managing Acute Radiation Dermatitis

King Hussein Cancer Center

Status: Not yet enrolling

Conditions: Acute Radiation Dermatitis; Head and Neck Cancer (H&N); Sarcomas

Treatments: Other: Normal Saline Soaks (0.9% Sodium Chloride)

Study type: Interventional

Funder types: Other

Identifiers

NCT07553260

26 KHCC 032 F (Other Grant/Funding Number)

Details and patient eligibility

About

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

Full description

Radiotherapy is a cornerstone in the management of many malignancies, including sarcomas and head and neck cancers. Despite its therapeutic benefits, radiation-induced skin reactions remain one of the most common adverse effects, with the majority of patients developing some degree of acute radiation dermatitis (ARD). These reactions range from mild erythema to severe moist desquamation, which can lead to pain, increased risk of infection, impaired quality of life, and potential interruptions in treatment delivery. Such interruptions may negatively impact treatment efficacy and overall clinical outcomes.

Supportive skin care during radiotherapy is therefore essential. Current management strategies include general skin care measures, topical corticosteroids, moisturizers, and advanced wound dressings. However, there is no universally accepted standard intervention for preventing or managing ARD, and practices often vary across institutions.

Normal saline (0.9% sodium chloride) soaks are widely used in clinical settings as a supportive, non-pharmacological intervention for managing skin reactions. Saline soaks are believed to cleanse the affected area, soften crusted tissue, reduce surface bacterial load, and maintain a moist wound environment that supports re-epithelialization. In addition, they are low-cost, easy to administer, and suitable for home use, making them an attractive option for routine supportive care. Despite their frequent inclusion in clinical practice guidelines and institutional protocols, there is limited high-quality evidence specifically evaluating their independent effectiveness in reducing the severity of ARD.

This study is designed as an open-label, randomized clinical trial to evaluate the effectiveness of standardized normal saline soaks when used in addition to standard skin care in patients undergoing radiotherapy for sarcomas or head and neck cancers. Participants will be randomly assigned in a 1:1 ratio to receive either standard care alone or standard care plus saline soaks. Randomization will be conducted using a computer-generated sequence to ensure balanced group allocation.

The intervention consists of applying sterile gauze soaked in room-temperature normal saline (0.9% NaCl) to the irradiated skin area for a short duration on a daily basis. The procedure will be demonstrated by trained nursing staff in the clinical setting, and participants will be instructed on proper technique for safe and consistent application at home. Adherence to the intervention will be reinforced خلال follow-up visits.

Skin reactions will be assessed regularly during the course of radiotherapy using a standardized and validated grading system. Additional clinical observations related to skin healing and treatment continuity will also be documented. All participants will continue to receive routine clinical follow-up as part of standard oncology care, with no additional visits required solely for research purposes.

This study aims to address an important gap in the evidence regarding a commonly used supportive care intervention. By evaluating the clinical impact of saline soaks in a controlled and systematic manner, the findings may help determine whether this approach provides measurable benefits beyond standard care alone. The results of this trial have the potential to inform clinical practice, contribute to the development of evidence-based guidelines, and support the implementation of accessible, cost-effective strategies for managing radiation-induced skin toxicity.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 1 patient group

Standard Care plus Normal Saline Soaks (Intervention Group)

Experimental group

Description:

Participants 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:

Other: Normal Saline Soaks (0.9% Sodium Chloride)