Clinical trial · Interventional
Effectiveness of 0.9% Normal Saline Soaking in Managing Acute Radiation Dermatitis
The Effectiveness of Saline Soaks in Managing Acute Radiation Dermatitis
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Radiation Dermatitis | — | UNRESOLVED | — |
| Head and Neck Cancer (H&N) | Malignant Head and Neck Neoplasm | ALIAS | 0.85 |
| Sarcomas | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Normal Saline Soaks (0.9% Sodium Chloride) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Standard Care plus Normal Saline Soaks (Intervention Group)
- description
- 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.
- interventionNames
- Other: Normal Saline Soaks (0.9% Sodium Chloride)
Primary outcomes (1)
- measure
- Incidence of Grade II or Higher Acute Radiation Dermatitis
- timeFrame
- During radiotherapy treatment period (approximately 6-7 weeks)
- description
- 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.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (6)
- BACKGROUNDWei 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 30613164
- BACKGROUNDSalvo 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 20697521
- BACKGROUNDPazdrowski 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 39144266
- BACKGROUNDLiu 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 39450273
- BACKGROUNDCao 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 39800331
- BACKGROUNDBehroozian 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.