UMIN-CTR Clinical Trial

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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

The efficacy of skin-moisturizing agents for radiation dermatitis and basic information associated with radiation dermatitis

Acronym

The efficacy of skin-moisturizing agents for radiation dermatitis

Scientific Title

The efficacy of skin-moisturizing agents for radiation dermatitis and basic information associated with radiation dermatitis

Scientific Title:Acronym

The efficacy of skin-moisturizing agents for radiation dermatitis

Region

Japan


Condition

Condition

Breast cancer

Classification by specialty

Breast surgery Radiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To confirm the efficacy of heparinoid for radiation dermatitis

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

Change of ratio of stratum corneum hydration after four weeks from end of radiotherapy

Key secondary outcomes

Sebaceous volume, activities of sebaceous glands, objective symptom, subjective symptom, sebaceous component


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Numbered container method


Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Application of heparinoid on the irradiated skin twice a day two weeks after the completion of whole breast irradiation

Interventions/Control_2

No application of heparinoid and other skin-moisturizing agents on the irradiated skin

Interventions/Control_3

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

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

30 years-old <=

Age-upper limit

60 years-old >=

Gender

Female

Key inclusion criteria

1.Breast cancer patients who are to be treated with whole breast irradiation
2. no previous radiotherapy
3. written in informed consent

Key exclusion criteria

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.

Target sample size

125


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kenji Sekiguchi

Organization

St Luke's international Hospital

Division name

Department of Radiation Oncology

Zip code


Address

9-1 Akashicho, Chuo-ku,Tokyo, Japan

TEL

03-5550-7006

Email

kenjisek@luke.or.jp


Public contact

Name of contact person

1st name
Middle name
Last name Mami Ogita

Organization

St Luke's international Hospital

Division name

Department of Radiation Oncology

Zip code


Address

9-1 Akashicho, Chuo-ku,Tokyo, Japan

TEL

03-5550-7006

Homepage URL


Email

keikoak@luke.or.jp


Sponsor or person

Institute

Department of Radiation Oncology
St Luke's international Hospital

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

聖路加国際病院            St Luke’s International Hospital


Other administrative information

Date of disclosure of the study information

2011 Year 04 Month 29 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results

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.

Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Enrolling by invitation

Date of protocol fixation

2011 Year 03 Month 20 Day

Date of IRB


Anticipated trial start date

2011 Year 04 Month 01 Day

Last follow-up date

2013 Year 09 Month 09 Day

Date of closure to data entry

2013 Year 09 Month 09 Day

Date trial data considered complete

2013 Year 09 Month 09 Day

Date analysis concluded

2013 Year 12 Month 01 Day


Other

Other related information

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.


Management information

Registered date

2011 Year 04 Month 29 Day

Last modified on

2013 Year 11 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006560


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name