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NCT05340673 · ClinicalTrials.gov registry record · Phase 1
Comparing Supplemental Topical Agents for the Treatment of Acute Radiation Dermatitis in Patients With Breast Cancer
A Phase 1 study of Invasive Breast Carcinoma and Breast Ductal Carcinoma In Situ, sponsored by City of Hope Medical Center.
- Active
- Registry status
- Phase 1
- Development phase
- 208
- Enrollment target
- 1
- Study location
NCT05340673: Active Phase 1 study of Invasive Breast Carcinoma and Breast Ductal Carcinoma In Situ, sponsored by City of Hope Medical Center.
NCT05340673 is a Phase 1 study of Invasive Breast Carcinoma and Breast Ductal Carcinoma In Situ that is active but no longer recruiting, run by City of Hope Medical Center. The registered enrollment target is 208 participants, below the 480-participant average among 45 other Invasive Breast Carcinoma trials with a reported enrollment target (57% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05340673, a Phase 1 study of Invasive Breast Carcinoma and Breast Ductal Carcinoma In Situ, is active but no longer recruiting, sponsored by City of Hope Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 208 participants
- Enrollment target
- 1
- Study location
Study Summary
This clinical trial compares two supplemental topical agents (Aquaphor and Miaderm) for the treatment of acute radiation dermatitis in patients with breast cancer undergoing radiation therapy. Radiation dermatitis is a radiation-induced skin reaction which can cause itching, swelling, pain, and general discomfort. Aquaphor is a commonly available, inexpensive, petrolatum-based multi-purpose ointment designed to protect and sooth extremely dry skin, chapped lips, cracked hands and feet, minor cuts and burns, and many other skin irritations. Miaderm is a water-based cream and contains ingredients like calendula, hyaluronate, and aloe vera which may help reduce occurrence and severity of radiation dermatitis. Both are commonly recommended and used by breast cancer patients undergoing external beam radiation therapy (EBRT). However, it is not known whether one is better than the other in treating or preventing radiation dermatitis.
Primary Outcome
Depending on prescribed duration of radiation treatment, each subject will contribute between 5 and 8 periodic assessments for the presence of acute radiation dermatitis Radiation Therapy Oncology Group / European Organization for Research and Treatment of Cancer (RTOG/EORTC toxicity score of 2 or higher). The hypothesized association between randomized treatment and the repeated binary outcome of Acute Radiation Dermatitis will be tested using repeated measures logistic regression. That model w
Conditions Studied
Interventions
- OTHER Quality-of-Life Assessment
- OTHER Questionnaire Administration
- DRUG Agent Affecting Integumentary System
- OTHER Petrolatum-Mineral Oil-Lanolin-Ceresin Ointment
Study Locations (1)
California
- City of Hope Medical Center - Duarte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 208 participants |
| Start Date | 2022-06-21 |
| Est. Completion | 2026-12-15 |
| Phase | Phase 1 |
What the registry record for NCT05340673 still lists
NCT05340673 is an interventional study that assigns participants to a tested intervention. The registered 208 participants enrollment target is mid-sized for trials with a published cap, below the 480-participant average among 45 other Invasive Breast Carcinoma trials with a reported enrollment target (57% lower).
The record links to 2 conditions, with Invasive Breast Carcinoma appearing as the primary indexed condition, and to 4 interventions - of which Quality-of-Life Assessment is the first listed.
NCT05340673 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT05340673 about?
NCT05340673 is a clinical study titled "Comparing Supplemental Topical Agents for the Treatment of Acute Radiation Dermatitis in Patients With Breast Cancer". This clinical trial compares two supplemental topical agents (Aquaphor and Miaderm) for the treatment of acute radiation dermatitis in patients with breast cancer undergoing radiation therapy. Radiation dermatitis is a radiation-induced skin reaction which can cause itching, swelling, pain, and gene...
What is the current status of trial NCT05340673?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 208 participants. The study started on 2022-06-21. Estimated completion is 2026-12-15.
What conditions does trial NCT05340673 study?
This clinical trial studies the following conditions: Invasive Breast Carcinoma, Breast Ductal Carcinoma In Situ.
What interventions are being tested in trial NCT05340673?
The interventions under investigation include: Quality-of-Life Assessment (OTHER), Questionnaire Administration (OTHER), Agent Affecting Integumentary System (DRUG), Petrolatum-Mineral Oil-Lanolin-Ceresin Ointment (OTHER).
Who is sponsoring clinical trial NCT05340673?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05340673 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05340673's enrollment target sits among peer trials
208 16th of 45 higher than 30 of 45 other Invasive Breast Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Invasive Breast Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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