An interventional study of Normal Saline Soaks (0.9% Sodium Chloride) in Acute Radiation Dermatitis, Head and Neck Cancer (H&N) and Sarcomas, sponsored by King Hussein Cancer Center. Not yet recruiting at 1 site in Jordan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-27.
Sponsored by King Hussein Cancer Center · Not applicable, Interventional, and Supportive care
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:
Participants will:
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.
2,710 studies on the registry are indexed under Head and Neck Neoplasms; 594 are open to participants now.
This study's planned enrollment of 150 is above the median of 46 across 2,032 interventional studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →King Hussein Cancer Center is the lead sponsor of 23 studies on the registry; 7 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Also known as: 0.9% Sodium Chloride Solution Soaks
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)
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)
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)
Plan to share: No — 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.
Start is estimated for May 2026; primary completion for May 2027, 12 months later.
Of 437 non-industry interventional studies with no phase under Head and Neck Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 71. This study's planned 12 months is below that.
Counting every sponsor, half of 455 studies reached it within 32 months; a quarter within 18 and three quarters within 70.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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King Hussein Cancer Center