UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027742
Receipt number R000031785
Scientific Title Safety and efficacy of ablative fractional CO2 laser thrapy for external genital and the vagina in women with breast cancer
Date of disclosure of the study information 2017/06/13
Last modified on 2021/06/16 14:31:16

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Basic information

Public title

Safety and efficacy of ablative fractional CO2 laser thrapy for external genital and the vagina in women with breast cancer

Acronym

AFLT study for MMK

Scientific Title

Safety and efficacy of ablative fractional CO2 laser thrapy for external genital and the vagina in women with breast cancer

Scientific Title:Acronym

AFLT study for MMK

Region

Japan


Condition

Condition

Symptom of vulvovaginal atrophy caused from low estrogen state

Classification by specialty

Obstetrics and Gynecology Urology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate cancer related low estrogen state and vulvovaginal atrophy and efficacy of AFLT for breast cancer patients

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Effect of AFLT on breast cancer patients at pre, 3 months, 6 months and one year by questionnaire

Key secondary outcomes

Effect of AFLT on breast cancer patients at pre, 3 months, 6 months and one year by objective evaluation and questionnaire.


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment Maneuver

Interventions/Control_1

Smarttxide2

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


Not applicable

Gender

Female

Key inclusion criteria

breast cancer patients with vulvovaginal atrophy symptoms

Key exclusion criteria

1) heart disease
2) severely lung disease
3) pelvic organ prolapse (more than 3)
4) pregnancy

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Noriko
Middle name
Last name Ninomiya

Organization

Women Clinic LUNA SHINSAIBASHI

Division name

Urology

Zip code

5420086

Address

1-13-21 Nishi-shinsaibashi Chuoh-ku Osaka

TEL

0662517505

Email

ninomiya5829@yahoo.co.jp


Public contact

Name of contact person

1st name Noriko
Middle name
Last name Ninomiya

Organization

Women Clinic LUNA SHINSAIBASHI

Division name

Urology

Zip code

5420086

Address

1-13-21 Nishi-shinnsaibashi Chuou-ku

TEL

0662517505

Homepage URL


Email

ninomiya5829@yahoo.co.jp


Sponsor or person

Institute

Medical corporation LEADING GIRLS

Institute

Department

Personal name



Funding Source

Organization

DEKA Japan co.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor

DEKA Japan co.

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Medical corporation LEADING GIRLS

Address

2-96 Motomachi nakaku Yokohama city

Tel

045-680-1226

Email

luna.makiskgc@gmail.com


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



Other administrative information

Date of disclosure of the study information

2017 Year 06 Month 13 Day


Related information

URL releasing protocol

no

Publication of results

Unpublished


Result

URL related to results and publications

no

Number of participants that the trial has enrolled

7

Results

Vaginal discomfort improved in all treated patients. The improvement in urinary tract symptoms was not significant, but in some patients there was a dramatic improvement.
No serious side effects were observed.

Results date posted

2021 Year 06 Month 16 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Women in their 50s or older with a history of breast cancer with one or more vaginal symptoms.

Participant flow

Irradiate the vagina and vulva with a fractional CO2 laser every 4 weeks
Irradiation 3 times in total
Evaluation is performed before the start of irradiation and one month after irradiation.

Adverse events

Pain during and after the procedure
Vaginitis

Outcome measures

Vaginal health index
OABSS

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2017 Year 05 Month 24 Day

Date of IRB

2017 Year 06 Month 14 Day

Anticipated trial start date

2017 Year 06 Month 14 Day

Last follow-up date

2018 Year 09 Month 30 Day

Date of closure to data entry

2019 Year 04 Month 30 Day

Date trial data considered complete

2019 Year 09 Month 30 Day

Date analysis concluded

2020 Year 04 Month 30 Day


Other

Other related information

nothing


Management information

Registered date

2017 Year 06 Month 13 Day

Last modified on

2021 Year 06 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031785


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name