Quantifying Radiation-Induced Skin Reactions: Establishing the Foundation for Future Prediction Models

February 5, 2024 updated by: Chin-Nan Chu, China Medical University Hospital

Breast cancer has the highest incidence rate among female cancers, and breast radiotherapy plays an essential role in the treatment of breast cancer. However, the acute and chronic skin reactions caused by radiotherapy, especially radiation dermatitis, have a significant impact on the physical and mental health of breast cancer patients. Severe acute radiation dermatitis can affect the patient's quality of life and may even lead to treatment interruption, thereby affecting treatment efficacy. Chronic radiation dermatitis can lead to irreversible skin problems, such as "radiation-irritated skin" and skin pigmentation, which can affect the quality of life of breast cancer patients after treatment.

This study aimed to evaluate and examine the skin reactions of 30 breast cancer patients who underwent whole-breast radiotherapy after breast conserving surgery. The subjects returned to the hospital for evaluation every week during radiotherapy, and in the second and sixth weeks after the end of the treatment, they received physical examinations and surveys, including questionnaire surveys, skin observations and measurements. The study lasted for 3 months. Skin observation items included physiological parameters such as skin moisture, temperature, melanin, transepidermal water loss (TEWL), and clinical evaluation of skin reactions by physicians. Through statistical analysis of skin physiological parameters, scientific instruments can quantify the radiation skin reactions traditionally judged by clinical physicians by visual examination and can perform real-time clinical prediction monitoring, which can be used to establish a skin reaction prediction model in the future.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Taichung, Taiwan
        • Recruiting
        • China Medical University Hospital
        • Contact:
          • Chin-Nan Chu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Diagnosis of non-inflammatory breast adenocarcinoma or in situ breast cancer which will be treated by radiotherapy after operation

Description

Inclusion Criteria:

  • Participants must be males or non-pregnant females at least 18 years of age.
  • Diagnosis of non-inflammatory breast adenocarcinoma or in situ breast cancer which will be treated by radiotherapy after operation.
  • Patient had unilateral breast conservation surgery with or without adjuvant or neoadjuvant chemotherapy or hormonal treatment.
  • Patients were scheduled to receive at least five sessions of radiotherapy per week (1 session per day) for at least four weeks using standard irradiation fraction (with at least 1.8 Gy per session) for total dose of at least 45 Gy.
  • Participant must give informed consent.

Exclusion Criteria:

  • Bilateral breast cancer
  • Previous radiotherapy to the chest
  • Prior breast reconstructions, implants, and/or expanders
  • Known radiosensitivity syndromes (e.g. Ataxia-telangiectasia)
  • Collagen vascular disease, vasculitis, unhealed surgical sites, breast infections or systemic lupus erythematosus (SLE)
  • Participation in any clinical trial in the prior 30 days from baseline.
  • Any condition that, in the judgement of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The worst skin toxicity according to CTCAE grading.
Time Frame: 1-Week (Day0), 2-Week (Day7), 3-Week (Day14), 4-Week (Day21), 5-Week (Day28), 6-Week (Day35), Post-radiotherapy 2 Week later
The worst skin toxicity during radiotherapy and 2 weeks after according to CTCAE grading.
1-Week (Day0), 2-Week (Day7), 3-Week (Day14), 4-Week (Day21), 5-Week (Day28), 6-Week (Day35), Post-radiotherapy 2 Week later

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To compare the skin moisture percentage.
Time Frame: 1-Week (Day0), 3-Week (Day14), 5-Week (Day28), 6-Week (Day35), Post-radiotherapy 2 Week later, Post-radiotherapy 6 Week later
To compare the skin moisture percentage at the radiotherapy site and normal site from baseline to follow-up visit.
1-Week (Day0), 3-Week (Day14), 5-Week (Day28), 6-Week (Day35), Post-radiotherapy 2 Week later, Post-radiotherapy 6 Week later
To compare the skin trans-epidermal water loss.
Time Frame: 1-Week (Day0), Post-radiotherapy 2 Week later, Post-radiotherapy 6 Week later
To compare the skin trans-epidermal water loss at the radiotherapy site and normal site from baseline to follow-up visit.
1-Week (Day0), Post-radiotherapy 2 Week later, Post-radiotherapy 6 Week later
To compare the skin temperature of target region.
Time Frame: 1-Week (Day0), 3-Week (Day14), 5-Week (Day28), 6-Week (Day35), Post-radiotherapy 2 Week later, Post-radiotherapy 6 Week later
To compare the skin temperature of target region at the radiotherapy site and normal site from baseline to follow-up visit.
1-Week (Day0), 3-Week (Day14), 5-Week (Day28), 6-Week (Day35), Post-radiotherapy 2 Week later, Post-radiotherapy 6 Week later
The score of quality of life with the Skindex-16 questionnaire performed every two weeks.
Time Frame: 1-Week (Day0), 3-Week (Day14), 5-Week (Day28), 6-Week (Day35), Post-radiotherapy 2 Week later, Post-radiotherapy 6 Week later
The score of quality of life with the Skindex-16 questionnaire performed every two weeks.
1-Week (Day0), 3-Week (Day14), 5-Week (Day28), 6-Week (Day35), Post-radiotherapy 2 Week later, Post-radiotherapy 6 Week later
Median time to G2 radiation dermatitis development
Time Frame: 1-Week (Day0), 2-Week (Day7), 3-Week (Day14), 4-Week (Day21), 5-Week (Day28), 6-Week (Day35), Post-radiotherapy 2 Week later, Post-radiotherapy 6 Week later
Median time to G2 radiation dermatitis development
1-Week (Day0), 2-Week (Day7), 3-Week (Day14), 4-Week (Day21), 5-Week (Day28), 6-Week (Day35), Post-radiotherapy 2 Week later, Post-radiotherapy 6 Week later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China Medical University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 9, 2023

Primary Completion (Estimated)

August 31, 2024

Study Completion (Estimated)

August 31, 2024

Study Registration Dates

First Submitted

August 31, 2023

First Submitted That Met QC Criteria

September 6, 2023

First Posted (Actual)

September 8, 2023

Study Record Updates

Last Update Posted (Actual)

February 7, 2024

Last Update Submitted That Met QC Criteria

February 5, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CMUH112-REC1-120

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Cancer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malaysia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe