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

NCT07553260 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-04-27

No results posted yet for this study

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. 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

  • Acute Radiation Dermatitis
  • Head and Neck Cancer (H&N)
  • Sarcomas

Interventions

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.

Sponsors & Collaborators

  • King Hussein Cancer Center

    lead OTHER

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2027-05-31
Completion
2027-06-30

Countries

  • Jordan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07553260 on ClinicalTrials.gov