Unique ID issued by UMIN | UMIN000005532 |
---|---|
Receipt number | R000006560 |
Scientific Title | The efficacy of skin-moisturizing agents for radiation dermatitis and basic information associated with radiation dermatitis |
Date of disclosure of the study information | 2011/04/29 |
Last modified on | 2013/11/08 14:18:04 |
The efficacy of skin-moisturizing agents for radiation dermatitis and basic information associated with radiation dermatitis
The efficacy of skin-moisturizing agents for radiation dermatitis
The efficacy of skin-moisturizing agents for radiation dermatitis and basic information associated with radiation dermatitis
The efficacy of skin-moisturizing agents for radiation dermatitis
Japan |
Breast cancer
Breast surgery | Radiology |
Malignancy
NO
To confirm the efficacy of heparinoid for radiation dermatitis
Efficacy
Exploratory
Pragmatic
Phase II
Change of ratio of stratum corneum hydration after four weeks from end of radiotherapy
Sebaceous volume, activities of sebaceous glands, objective symptom, subjective symptom, sebaceous component
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
No treatment
YES
YES
Institution is not considered as adjustment factor.
NO
Numbered container method
3
Treatment
Medicine |
Application of heparinoid on the irradiated skin twice a day two weeks after the completion of whole breast irradiation
No application of heparinoid and other skin-moisturizing agents on the irradiated skin
Prophylactic application of heparinoid on the irradiated skin twice a day from the start of radiotherapy and continuing it after the completion of whole breast irradiation
30 | years-old | <= |
60 | years-old | >= |
Female
1.Breast cancer patients who are to be treated with whole breast irradiation
2. no previous radiotherapy
3. written in informed consent
1. Patients with widespread skin complications
2. Patients who have past history of collagen vascular diseases
3. Patients who were sensitive to heparinoid
4. Patients who were judged unsuitable for this study by the investigator.
125
1st name | |
Middle name | |
Last name | Kenji Sekiguchi |
St Luke's international Hospital
Department of Radiation Oncology
9-1 Akashicho, Chuo-ku,Tokyo, Japan
03-5550-7006
kenjisek@luke.or.jp
1st name | |
Middle name | |
Last name | Mami Ogita |
St Luke's international Hospital
Department of Radiation Oncology
9-1 Akashicho, Chuo-ku,Tokyo, Japan
03-5550-7006
keikoak@luke.or.jp
Department of Radiation Oncology
St Luke's international Hospital
none
Self funding
Japan
NO
聖路加国際病院 St Luke’s International Hospital
2011 | Year | 04 | Month | 29 | Day |
Unpublished
A total of 62 patients were analysed. Before randomization, the affected / contralateral skin water content ratio was 0.97 +/-0.13 at the beginning, 0.79+/-0.15 (p=0.00) at the RT completion, and 0.77 +/-0.15 (p=0.00) two weeks after RT. The difference of skin water content ratio comparing four weeks to two weeks after the completion of RT was 0.242 +/-0.225 in moisturizer group and 0.055 +/- 0.145 in no treatment group (p=0.001); indicating the skin water content was significantly increased in moisturizer group.
Enrolling by invitation
2011 | Year | 03 | Month | 20 | Day |
2011 | Year | 04 | Month | 01 | Day |
2013 | Year | 09 | Month | 09 | Day |
2013 | Year | 09 | Month | 09 | Day |
2013 | Year | 09 | Month | 09 | Day |
2013 | Year | 12 | Month | 01 | Day |
Pain score at three months after RT was less in moisturizer group (0.23 +/-0.90 in moisturizer group and 1.58 +/-3.44 in no treatment group, p=0.026). However, there was no difference in pruritus scores between the groups.
2011 | Year | 04 | Month | 29 | Day |
2013 | Year | 11 | Month | 08 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006560