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Acute Radiation DermatitisNCT07553260

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

A study testing Normal Saline Soaks (0.9% Sodium Chloride) in people with Acute Radiation Dermatitis and Head and Neck Cancer (H&N), run by King Hussein Cancer Center at 1 site in Jordan.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Normal Saline Soaks (0.9% Sodium Chloride)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteJordan
Study dates
May 2026to Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Muna Al Sayed, BSN contact

+962 7 97775542

MA.07855@KHCC.JO

Jordan1 site
  • King Hussien Cancer Center

    Amman, Al-Jubeiha, 11941

Other trials in Jordan

About this study

Official title: 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.
Read more

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
Read the 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.

Being tested
Normal Saline Soaks (0.9% Sodium Chloride)
Keywords
Dermatitis, Radiation-Induced, Skin Diseases, Radiation-Induced, Radiotherapy, Head and Neck Neoplasms, Sarcoma, Sodium Chloride, Wound Healing, Skin Care, Moist Desquamation, Supportive Care, Treatment Outcome
Medical subject headings
Head and Neck Neoplasms, Sarcoma, Radiodermatitis, Skin Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Normal Saline Soaks (0.9% Sodium Chloride)Other

    Also called 0.9% Sodium Chloride Solution Soaks

    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.

Study groups in NCT07553260
Study groupRoleWhat they receive
Standard Care plus Normal Saline Soaks (Intervention Group)ExperimentalParticipants 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.
Receives: Other: Normal Saline Soaks (0.9% Sodium Chloride)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: During radiotherapy treatment period (approximately 6-7 weeks)

Secondary outcomes (2)
  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.

    Measured: 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.

    Measured: During the full course of radiotherapy (approximately 6-7 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Apr 2026
  2. Study startMay 2026 (estimated)
  3. Primary completionMay 2027 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07553260
Sponsor's protocol ID
26 KHCC 032 F
Other IDs
26 KHCC 032 F
Status last verified
Apr 2026
First submitted
20 Apr 2026
Last updated
27 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Publications

  • Wei J, Meng L, Hou X, Qu C, Wang B, Xin Y, Jiang X. Radiation-induced skin reactions: mechanism and treatment. Cancer Manag Res. 2018 Dec 21;11:167-177. doi: 10.2147/CMAR.S188655. eCollection 2019.

    PubMed 30613164
  • Salvo N, Barnes E, van Draanen J, Stacey E, Mitera G, Breen D, Giotis A, Czarnota G, Pang J, De Angelis C. Prophylaxis and management of acute radiation-induced skin reactions: a systematic review of the literature. Curr Oncol. 2010 Aug;17(4):94-112. doi: 10.3747/co.v17i4.493.

    PubMed 20697521
  • Pazdrowski J, Gornowicz-Porowska J, Kazmierska J, Krajka-Kuzniak V, Polanska A, Masternak M, Szewczyk M, Golusinski W, Danczak-Pazdrowska A. Radiation-induced skin injury in the head and neck region: pathogenesis, clinics, prevention, treatment considerations and proposal for management algorithm. Rep Pract Oncol Radiother. 2024 Jul 22;29(3):373-390. doi: 10.5603/rpor.100775. eCollection 2024.

    PubMed 39144266
  • Liu C, Wei J, Wang X, Zhao Q, Lv J, Tan Z, Xin Y, Jiang X. Radiation-induced skin reactions: oxidative damage mechanism and antioxidant protection. Front Cell Dev Biol. 2024 Oct 9;12:1480571. doi: 10.3389/fcell.2024.1480571. eCollection 2024.

    PubMed 39450273
  • Cao JQ, Yassa M, Bolivar CHA, Dahn H, Kong I, Logie N, Theberge V, Wiebe E, Caudrelier JM, Bourque JM, Panet-Raymond V, Rodin D, Wright P, Bashir B, Marchuk S, Sauder M, Claveau J, Dayeh N, Chow E, Hijal T. Modified Delphi Consensus on Interventions for Acute Radiation Dermatitis in Breast Cancer: A Canadian Expert Perspective. Int J Radiat Oncol Biol Phys. 2025 Jun 1;122(2):267-274. doi: 10.1016/j.ijrobp.2024.12.037. Epub 2025 Jan 10.

    PubMed 39800331
  • Behroozian T, Bonomo P, Patel P, Kanee L, Finkelstein S, van den Hurk C, Chow E, Wolf JR; Multinational Association of Supportive Care in Cancer (MASCC) Oncodermatology Study Group Radiation Dermatitis Guidelines Working Group. Multinational Association of Supportive Care in Cancer (MASCC) clinical practice guidelines for the prevention and management of acute radiation dermatitis: international Delphi consensus-based recommendations. Lancet Oncol. 2023 Apr;24(4):e172-e185. doi: 10.1016/S1470-2045(23)00067-0.

    PubMed 36990615

Questions about this trial

What is this clinical trial studying?

A study testing Normal Saline Soaks (0.9% Sodium Chloride) in people with Acute Radiation Dermatitis and Head and Neck Cancer (H&N), run by King Hussein Cancer Center at 1 site in Jordan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Muna Al Sayed, BSN (+962 7 97775542, MA.07855@KHCC.JO), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Grade II or Higher Acute Radiation Dermatitis (time frame: During radiotherapy treatment period (approximately 6-7 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07553260, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026; AzTrials last refreshed its copy on 6 Nov 2026.

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