UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015757 |
|---|---|
| Receipt number | R000017783 |
| Scientific Title | Research on a Quantitative Assessment of Radiation-Induced Skin Symptoms |
| Date of disclosure of the study information | 2014/11/26 |
| Last modified on | 2020/06/12 18:09:49 |
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Basic information
Public title
Research on a Quantitative Assessment of Radiation-Induced Skin Symptoms
Acronym
Quantitative Assessment of Radiation-Induced Skin Symptoms
Scientific Title
Research on a Quantitative Assessment of Radiation-Induced Skin Symptoms
Scientific Title:Acronym
Quantitative Assessment of Radiation-Induced Skin Symptoms
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Radiology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purposes of this study are to assess multilateral changes of radiation-induced skin symptoms quantitatively and find out relations with the exposure dose. The study also uses a qualitative grading evaluation and QOL questionnaires and examines the effectiveness of the assessments.
Basic objectives2
Others
Basic objectives -Others
To assess successive changes in skin symptoms.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Period: Before radiation therapy, during radiation therapy (once in a week), after radiation therapy (2 and 6 weeks, 3 and 6 months, and 1 year post treatment)
<Assessment by devices>
Erythema & melanin index
Key secondary outcomes
Period: Before radiation therapy, during radiation therapy (once in a week), after radiation therapy (2 and 6 weeks, 3 and 6 months, and 1 year post treatment)
<Assessment by devices>
1) Transepidermal water loss
2) Capacitance (stratum corneum-epidermal water)
3) Skin temperature
<Visual assessment>
NCI-CTC (ver.4.0 Japanese version JCOG)
<Self-completed questionnaires>
Skindex 29 (QOL regarding skin symptoms)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 69 | years-old | >= |
Gender
Female
Key inclusion criteria
1) Patients with breast cancer who are treated with whole-breast radiation after breast-conserving surgery.
2) PS is from 0 to 1.
3) Patients who agreed to participate in this study.
Key exclusion criteria
1) Patients who should be treated with a boost radiation.
2) Patients who are treated with pharmacotherapy except for hormone therapy during radiation therapy.
3) Patients who are unable to respond to self-completed questionnaires.
4) Physician decides it is inappropriate for the patient to participate in this study.
5) Patients who are going to stop radiation therapy for a long time (e.g., at the end of and the beginning of a year).
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Sekine |
Organization
The Jikei University School of Medicine
Division name
Department of Radiology
Zip code
201-8601
Address
4-11-1 Izumi-Honcyo, Komae, Tokyo 201-8601, Japan
TEL
03-3480-1151
h-sekine@jikei.ac.jp
Public contact
Name of contact person
| 1st name | Nozawa |
| Middle name | |
| Last name | Keiko |
Organization
National Cancer Center Hospital
Division name
Appearance Support Center
Zip code
104-0045
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045
TEL
03-3547-5201(3015)
Homepage URL
knozawa@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital, Appearance Support Center
Institute
Department
Personal name
Funding Source
Organization
Health and Labor Sciences Research Grants 2014
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
The Jikei University
Mie University
Tohoku University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center Institutional Review Board
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045
Tel
03-3542-2511
NCC_IRBoffice@ml.res.ncc.go.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
国立がん研究センター中央病院（東京都）、東京慈恵会医科大学病院（東京都）
三重大学病院（三重県）、東北大学病院（宮城県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 11 | Month | 26 | Day |
Related information
URL releasing protocol
Breast Cancer On line: 03 May 2020 https://doi.org/10.1007/s12282-020-01082-3
Publication of results
Published
Result
URL related to results and publications
Breast Cancer On line: 03 May 2020 https://doi.org/10.1007/s12282-020-01082-3
Number of participants that the trial has enrolled
43
Results
Finally, 40 patients were followed until 1 year after irradiation.
The order of symptom manifestation for the qualitative evaluation was skin erythema, dryness, and pigmentation. Quantitative measurements revealed the effects of irradiation earlier than did qualitative indices. Although the grades of skin erythema and pigmentation were correlated with the quantitative measurements, no significant correlation was observed between the skin dryness grade and skin barrier function.
Results date posted
| 2020 | Year | 06 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Female patients with newly diagnosed unilateral breast cancer were enrolled. All patients underwent BCS followed by whole-breast irradiation (WBI).
The exclusion criteria were an age >70 years; previous history of contralateral beast cancer; receipt of boost irradiation after WBI; receipt of chemotherapy before, simultaneously with, or after the completion of irradiation; connective tissue disease; and expected long-term interruption of radiation therapy.
Participant flow
Participants who received BCS were irradiated with tangential opposed fields with a dose of 50 Gy in 25 fractions. Qualitative and quantitative evaluation of radiation dermatitis were performed weekly during irradiation and periodically until 1 year of irradiation.
Adverse events
This study confirms whether the qualitative evaluation of radiation dermatitis, which is a side effect of radiotherapy, is reproducible between and within evaluators by comparing it with quantitative evaluation. The subject is a radiotherapy patient after breast-conserving surgery in which the method of radiotherapy is uniform. There were no adverse effects that interrupted the irradiation with this treatment.
Outcome measures
Symptoms (erythema, pigmentation, and skin dryness) and biophysical parameters (erythema, pigmentation, barrier function, and skin temperature) of radiation dermatitis were measured weekly during radiation therapy and periodically until 1 year after irradiation.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 11 | Month | 04 | Day |
Date of IRB
| 2014 | Year | 10 | Month | 30 | Day |
Anticipated trial start date
| 2014 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study evaluates radiation-induced skin symptoms and QOL quantitatively and qualitatively.
Management information
Registered date
| 2014 | Year | 11 | Month | 26 | Day |
Last modified on
| 2020 | Year | 06 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017783
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