Miaderm vs Aquaphor for Radiation Dermatitis in Breast Cancer Patients
This study aims to compare the effectiveness of Miaderm and Aquaphor in managing acute radiation dermatitis in breast cancer patients undergoing radiation therapy, by assessing the presence of skin reactions over the course of the treatment.
Agent Affecting Integumentary System
+ Quality-of-Life Assessment
+ Questionnaire Administration
Breast Carcinoma In Situ+6
+ Adenocarcinoma
+ Carcinoma
Supportive Care Study
Summary
Study start date: June 21, 2022
Actual date on which the first participant was enrolled.This clinical trial aims to compare the effectiveness of two topical treatments, Miaderm and Aquaphor, in managing radiation dermatitis. Radiation dermatitis is a common side effect experienced by breast cancer patients undergoing external beam radiation therapy (EBRT) to the breast or chest wall. The study's primary goal is to determine which of these two treatments is more effective in preventing or treating this condition. The trial is particularly important as it could help improve the quality of life for breast cancer patients undergoing radiation therapy, by identifying a more effective treatment for radiation dermatitis. Participants in this study are randomly assigned to one of two groups. The first group applies Aquaphor twice daily, starting from the first day of radiation therapy, to the area receiving radiation, with the exception of the four hours before treatment. This continues until two weeks after the completion of radiation therapy. The second group follows the same procedure but uses Miaderm instead of Aquaphor. After the completion of the treatment, patients are followed up at two weeks and then between 90 to 120 days. The study measures the effectiveness of these treatments by assessing the presence of acute radiation dermatitis using the Radiation Therapy Oncology Group / European Organization for Research and Treatment of Cancer (RTOG/EORTC toxicity score). The analysis will take into account the repeated assessments for each patient to understand the association between the treatment and the outcome.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.208 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Supportive Care Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location