NCT07553260

Brief 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. The main questions it aims to answer are:

  1. 1.Does the application of normal saline soaks reduce the severity of acute radiation dermatitis according to CTCAE Version 5.0?
  2. 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.
  3. 3.Be randomly assigned to receive either standard care alone or standard care with daily saline soaks
  4. 4.Apply saline-soaked gauze to the affected radiation area for 5-10 minutes once daily (intervention group only)
  5. 5.Attend weekly clinic visits for skin assessment during radiotherapy
  6. 6.Be assessed for skin reaction severity, wound healing, and treatment interruptions at baseline, after 4 weeks, and 2 weeks after completing treatment

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
13mo left

Started May 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress2%
May 2026Jun 2027

First Submitted

Initial submission to the registry

April 20, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 27, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

April 27, 2026

Status Verified

April 1, 2026

Enrollment Period

1 year

First QC Date

April 20, 2026

Last Update Submit

April 20, 2026

Conditions

Head and Neck Cancer (H&N)Acute Radiation DermatitisSarcomas

Keywords

Dermatitis, Radiation-InducedSkin Diseases, Radiation-InducedRadiotherapyHead and Neck NeoplasmsSarcomaSodium ChlorideWound HealingSkin CareMoist DesquamationSupportive CareTreatment Outcome

Outcome Measures

Primary Outcomes (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.

    During radiotherapy treatment period (approximately 6-7 weeks)

Secondary Outcomes (2)

  • Time to Wound Healing of Radiation-Induced Skin Reactions

    From onset of skin reaction until complete epithelialization (up to 8 weeks)

  • Frequency and Duration of Radiotherapy Interruptions Due to Skin Toxicity

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

Study Arms (1)

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.

Other: Normal Saline Soaks (0.9% Sodium Chloride)

Interventions

Normal Saline Soaks (0.9% Sodium Chloride)OTHER

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
Standard Care plus Normal Saline Soaks (Intervention Group)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Hussien Cancer Center

Amman, Al-Jubeiha, 11941, Jordan

Location

Related Publications (6)

  • 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.

    PMID: 30613164BACKGROUND

  • 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.

    PMID: 20697521BACKGROUND

  • 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.

    PMID: 39144266BACKGROUND

  • 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.

    PMID: 39450273BACKGROUND

  • 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.

    PMID: 39800331BACKGROUND

  • 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.

    PMID: 36990615BACKGROUND

Related Links

MeSH Terms

Conditions

Head and Neck NeoplasmsSarcomaRadiodermatitisSkin Diseases

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeDermatitisSkin and Connective Tissue DiseasesRadiation InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Central Study Contacts

Muna Al Sayed, BSN

CONTACT

+962 7 97775542MA.07855@KHCC.JO

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2026

First Posted

April 27, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

April 27, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

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.

Locations

JO(1)