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.
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
- Conditions the study is for
- Acute Radiation Dermatitis, Head and Neck Cancer (H&N), Sarcomas
- 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.
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:
- Does the application of normal saline soaks reduce the severity of acute radiation dermatitis according to CTCAE Version 5.0?
- 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:
- Be randomly assigned to receive either standard care alone or standard care with daily saline soaks
- Apply saline-soaked gauze to the affected radiation area for 5-10 minutes once daily (intervention group only)
- Attend weekly clinic visits for skin assessment during radiotherapy
- 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 group | Role | What they receive |
|---|---|---|
| Standard Care plus Normal Saline Soaks (Intervention Group) | Experimental | 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. 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.
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)
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)
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.
- First posted27 Apr 2026
- Study startMay 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Acute Radiation DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- King Hussein Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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 30613164Salvo 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 20697521Pazdrowski 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 39144266Liu 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 39450273Cao 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 39800331Behroozian 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
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Saline Soaks in Managing Acute Radiation Dermatitis
- ClinicalTrials.gov ID
- NCT07553260
- Acronym / sponsor ID
- 26 KHCC 032 F
- Keywords
- Dermatitis, Radiation-Induced, Skin Diseases, Radiation-Induced, Radiotherapy, Head and Neck Neoplasms, Sarcoma, Sodium Chloride, Wound Healing, Skin Care
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- King Hussein Cancer CenterUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 27 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does the application of normal saline soaks reduce the severity of acute radiation dermatitis according to CTCAE Version 5.0?
- 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:
- Be randomly assigned to receive either standard care alone or standard care with daily saline soaks
- Apply saline-soaked gauze to the affected radiation area for 5-10 minutes once daily (intervention group only)
- Attend weekly clinic visits for skin assessment during radiotherapy
- Be assessed for skin reaction severity, wound healing, and treatment interruptions at baseline, after 4 weeks, and 2 weeks after completing 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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Standard Care plus Normal Saline Soaks (Intervention Group) | Experimental | 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Normal Saline Soaks (0.9% Sodium Chloride)Also: 0.9% Sodium Chloride Solution SoaksParticipants 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 | Standard Care plus Normal Saline Soaks (Intervention Group) |
Primary outcome
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.
2 secondary outcomes
Time to Wound Healing of Radiation-Induced Skin Reactions
Time frame: 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Background: PubMed 30613164Wei 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.
- Background: PubMed 20697521Salvo 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.
- Background: PubMed 39144266Pazdrowski 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.
- Background: PubMed 39450273Liu 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.
- Background: PubMed 39800331Cao 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.
- Background: PubMed 36990615Behroozian 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.
- Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 quick reference guide for grading radiation dermatitis.Link provided by the sponsor.
- MD Anderson Cancer Center clinical algorithm for radiation therapy-related skin toxicity management and supportive care.Link provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
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.