Comparing Supplemental Topical Agents for the Treatment of Acute Radiation Dermatitis in Patients With Breast Cancer
Primary Purpose
Breast Ductal Carcinoma In Situ, Invasive Breast Carcinoma
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Agent Affecting Integumentary System
Petrolatum-Mineral Oil-Lanolin-Ceresin Ointment
Quality-of-Life Assessment
Questionnaire Administration
Sponsored by
About this trial
This is an interventional supportive care trial for Breast Ductal Carcinoma In Situ
Eligibility Criteria
Inclusion Criteria:
- Documented informed consent of the participant and/or legally authorized representative.
- Age > 18 years.
- Undergoing external beam radiation therapy (EBRT) to the breast or chest wall following surgical resection (lumpectomy or mastectomy) for ductal carcinoma in situ (DCIS) or invasive breast cancer using either conventional fractionation or hypofractionation.
Exclusion Criteria:
- Partial breast irradiation.
- Prior radiation overlapping with the intended radiotherapy field.
- History of systemic radiation sensitivity diseases (xeroderma pigmentosum, ataxia telangiectasia).
- Extreme hypofractionation (less than 15 fractions of radiation).
- Palliative treatment.
- Patient intention to use topical product other than Aquaphor or Miaderm.
- Inflammatory breast cancer, skin involvement, planned use of bolus.
Sites / Locations
- City of Hope Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Arm I (Aquaphor)
Arm II (Miaderm)
Arm Description
Beginning on day 1 of radiation therapy, patients apply Aquaphor BID, but not within the four hours before EBRT, to the irradiated field until 2 weeks following completion of EBRT.
Beginning on day 1 of radiation therapy, patients apply Miaderm BID, but not within the four hours before EBRT, to the irradiated field until 2 weeks following completion of EBRT.
Outcomes
Primary Outcome Measures
Acute Radiation Dermatitis
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 will be implemented with PROC GENMOD (SAS software) for a generalized linear regression model with generalized estimating equation (GEE) for binary data with logit link function. In this way, the analysis will recognize the within-patient correlation inherent in repeated assessments.
Secondary Outcome Measures
Quality of life (QoL)
Skindex-16 is a single-page, validated measure of the effects of skin disease on patients' quality of life. The 16 questions address Symptoms (4 items), Emotions (7 items), and Functioning (5 items). Using a 7-level scale that is scored from 0 (Never bothered) to 100 (Always bothered), each question asks how much during the last 7 days the patient has been bothered by a specific aspect of their disease. Responses are averaged to generate a Global score and 3 domain-specific sub-scores, all ranging from 0 to 100, with higher scores indicating worse disease-related quality of life. Evaluated by the Skindex-16 questionnaire will be compared between the two study arms. T tests will be applied to assess mean differences between arms at each time point.
Supportive measures
Depending on prescribed duration of radiation treatment, each subject will contribute between 5 and 8 periodic assessments for the use of Concomitant Therapy for acute radiation dermatitis. The hypothesized association between randomized treatment and the repeated binary outcome of Concomitant Therapy will be tested using repeated measures logistic regression. Similar to the analysis of the Primary Endpoint described above, this model will be implemented with PROC GENMOD (SAS software) for a generalized linear regression model with GEE for binary data with logit link function and will consider potential covariates and possible treatment-by-time interaction as described above for the Primary Endpoint analysis.
Full Information
NCT ID
NCT05340673
First Posted
March 24, 2022
Last Updated
June 12, 2023
Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT05340673
Brief Title
Comparing Supplemental Topical Agents for the Treatment of Acute Radiation Dermatitis in Patients With Breast Cancer
Official Title
A Randomized Clinical Trial Comparing Supplemental Topical Treatments for Acute Radiation Dermatitis in Breast Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 21, 2022 (Actual)
Primary Completion Date
June 21, 2024 (Anticipated)
Study Completion Date
June 21, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed Description
PRIMARY OBJECTIVE:
I. Determine the efficacy of Miaderm compared to Aquaphor in the treatment and/or prevention of radiation dermatitis caused by EBRT in breast cancer patients undergoing EBRT to the breast/chest wall.
SECONDARY OBJECTIVE:
I. Determine quality of life (QoL) and need for additional concomitant therapies to address dermatitis in breast cancer patients undergoing EBRT to the breast/chest wall using Miaderm compared to Aquaphor.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Beginning on day 1 of radiation therapy, patients apply Aquaphor twice daily (BID), but not within the four hours before EBRT, to the irradiated field until 2 weeks following completion of EBRT.
ARM II: Beginning on day 1 of radiation therapy, patients apply Miaderm BID, but not within the four hours before EBRT, to the irradiated field until 2 weeks following completion of EBRT.
After completion of study treatment, patients are followed up at 2 weeks and then at 90-120 days.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Ductal Carcinoma In Situ, Invasive Breast Carcinoma
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm I (Aquaphor)
Arm Type
Experimental
Arm Description
Beginning on day 1 of radiation therapy, patients apply Aquaphor BID, but not within the four hours before EBRT, to the irradiated field until 2 weeks following completion of EBRT.
Arm Title
Arm II (Miaderm)
Arm Type
Experimental
Arm Description
Beginning on day 1 of radiation therapy, patients apply Miaderm BID, but not within the four hours before EBRT, to the irradiated field until 2 weeks following completion of EBRT.
Intervention Type
Drug
Intervention Name(s)
Agent Affecting Integumentary System
Intervention Description
Apply Miaderm
Intervention Type
Other
Intervention Name(s)
Petrolatum-Mineral Oil-Lanolin-Ceresin Ointment
Other Intervention Name(s)
Aquaphor
Intervention Description
Apply to skin
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Acute Radiation Dermatitis
Description
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 will be implemented with PROC GENMOD (SAS software) for a generalized linear regression model with generalized estimating equation (GEE) for binary data with logit link function. In this way, the analysis will recognize the within-patient correlation inherent in repeated assessments.
Time Frame
Up to 120 days after completion of radiation therapy
Secondary Outcome Measure Information:
Title
Quality of life (QoL)
Description
Skindex-16 is a single-page, validated measure of the effects of skin disease on patients' quality of life. The 16 questions address Symptoms (4 items), Emotions (7 items), and Functioning (5 items). Using a 7-level scale that is scored from 0 (Never bothered) to 100 (Always bothered), each question asks how much during the last 7 days the patient has been bothered by a specific aspect of their disease. Responses are averaged to generate a Global score and 3 domain-specific sub-scores, all ranging from 0 to 100, with higher scores indicating worse disease-related quality of life. Evaluated by the Skindex-16 questionnaire will be compared between the two study arms. T tests will be applied to assess mean differences between arms at each time point.
Time Frame
Up to 120 days after completion of radiation therapy
Title
Supportive measures
Description
Depending on prescribed duration of radiation treatment, each subject will contribute between 5 and 8 periodic assessments for the use of Concomitant Therapy for acute radiation dermatitis. The hypothesized association between randomized treatment and the repeated binary outcome of Concomitant Therapy will be tested using repeated measures logistic regression. Similar to the analysis of the Primary Endpoint described above, this model will be implemented with PROC GENMOD (SAS software) for a generalized linear regression model with GEE for binary data with logit link function and will consider potential covariates and possible treatment-by-time interaction as described above for the Primary Endpoint analysis.
Time Frame
Up to 120 days after completion of radiation therapy
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Documented informed consent of the participant and/or legally authorized representative.
Age > 18 years.
Undergoing external beam radiation therapy (EBRT) to the breast or chest wall following surgical resection (lumpectomy or mastectomy) for ductal carcinoma in situ (DCIS) or invasive breast cancer using either conventional fractionation or hypofractionation.
Exclusion Criteria:
Partial breast irradiation.
Prior radiation overlapping with the intended radiotherapy field.
History of systemic radiation sensitivity diseases (xeroderma pigmentosum, ataxia telangiectasia).
Extreme hypofractionation (less than 15 fractions of radiation).
Palliative treatment.
Patient intention to use topical product other than Aquaphor or Miaderm.
Inflammatory breast cancer, skin involvement, planned use of bolus.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott M Glaser
Organizational Affiliation
City of Hope Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
City of Hope Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Scott M. Glaser
Phone
626-218-2247
Email
sglaser@coh.org
First Name & Middle Initial & Last Name & Degree
Scott M. Glaser
12. IPD Sharing Statement
Learn more about this trial
Comparing Supplemental Topical Agents for the Treatment of Acute Radiation Dermatitis in Patients With Breast Cancer
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