A Phase 1 interventional study of CSMed Dressing in Radiation Dermatitis, sponsored by Chung Shan Medical University. Completed at 1 site in Taiwan. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-08-25.
Sponsored by Chung Shan Medical University · Phase 1, Interventional, and Treatment
Investigate the effects of CSMed® for preventing and managing radiation dermatitis in patients with Breast cancer and Head-Neck cancer receiving radiotherapy (≥50 Gy).
A prospective study was conducted at the University Hospital Medical Center. The patient received part of the breast/neck skin CSMed® dressing or clinical routine skin care. Record the difference between the part of the skin with dressing and undressed skin for each patient. The severity of acute radiation dermatitis was graded using the RTOG clinical scoring standard. From the beginning of the treatment to 4 weeks after the end of the treatment, skin pain, itching, local fever and tightness, as well as skin healing time were collected every week.
1,435 studies on the registry are indexed under Dermatitis; 131 are open to participants now.
This study's enrollment of 30 is below the median of 64 across 1,131 interventional studies indexed under Dermatitis.
Browse Dermatitis studies →Chung Shan Medical University is the lead sponsor of 124 studies on the registry; 26 are open to participants now.
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Exclusion Criteria:
The patient received part of the breast/neck skin CSMed® dressing or clinical routine skin care.
Drug: CSMed Dressing
Half of the irradiated area was covered with CSMed® and the other half was under routine treatment. An irradiated area of 11cm\*14cm with best fit or easy accessibility was chosen for CSMed® dressing application. The area without dressing was treated with routine skin care in each patient.
Severity of acute radiation dermatitis
The severity of radiation dermatitis can be assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE). Grade 1 to 5. NCI CTCAE grade 1 - Faint erythema with dry desquamation. NCI CTCAE grade 2 - Moderate dermatitis is characterized by moderate to brisk erythema and patchy, moist desquamation mostly confined to skin folds and creases. NCI CTCAE grade 3 - There is confluent, moist desquamation in locations other than skin folds. NCI CTCAE grade 4 - This is characterized by skin necrosis or ulceration of full-thickness dermis. NCI CTCAE grade 5 - Death due to dermatitis alone is a very rare event. Radiologists performed radiation therapy according to the needs of clinical diseases. Evaluate and record the case after radiotherapy at 4 weeks, and end the research record.
Time frame: 4 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Chung Shan Medical University