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

April 20, 2026 updated by: King Hussein Cancer Center

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Muna Al Sayed, BSN
  • Phone Number: +962 7 97775542
  • Email: MA.07855@KHCC.JO

Study Locations

  • Jordan
    • Al-Jubeiha
      • Amman, Al-Jubeiha, Jordan, 11941
        • King Hussien Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Standard Care plus Normal Saline Soaks (Intervention Group)
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.
Other: Normal Saline Soaks (0.9% Sodium Chloride)
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.
Other Names:
  • 0.9% Sodium Chloride Solution Soaks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Grade II or Higher Acute Radiation Dermatitis
Time Frame: During radiotherapy treatment period (approximately 6-7 weeks)
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.
During radiotherapy treatment period (approximately 6-7 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Wound Healing of Radiation-Induced Skin Reactions
Time Frame: From onset of skin reaction until complete epithelialization (up to 8 weeks)
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.
From onset of skin reaction until complete epithelialization (up to 8 weeks)
Frequency and Duration of Radiotherapy Interruptions Due to Skin Toxicity
Time Frame: During the full course of radiotherapy (approximately 6-7 weeks)
This outcome assesses the number and total duration of unplanned radiotherapy treatment interruptions caused by acute radiation dermatitis or related skin toxicity.
During the full course of radiotherapy (approximately 6-7 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King Hussein Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

April 20, 2026

First Submitted That Met QC Criteria

April 20, 2026

First Posted (Actual)

April 27, 2026

Study Record Updates

Last Update Posted (Actual)

April 27, 2026

Last Update Submitted That Met QC Criteria

April 20, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 26 KHCC 032 F (Other Grant/Funding Number: King Hussien Cance Center)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

De-identified individual participant data (IPD) from this study will be made available upon reasonable request after publication of the primary results. Data will be shared with qualified researchers for academic and non-commercial research purposes. Requests must include a clear research proposal and will be subject to review and approval by the principal investigator and the institutional ethics committee to ensure compliance with ethical and data protection regulations. All shared datasets will be fully de-identified to protect participant confidentiality. Supporting documents, including the study protocol, statistical analysis plan, and informed consent materials, may also be made available under similar conditions.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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