UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022259
Receipt number R000024061
Scientific Title Effect of acupuncture on xerostomia by radiotherapy for head and neck cancer
Date of disclosure of the study information 2016/05/20
Last modified on 2016/05/10 15:27:25

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Basic information

Public title

Effect of acupuncture on xerostomia by radiotherapy for head and neck cancer

Acronym

Effect of acupuncture on xerostomia by radiotherapy for head and neck cancer

Scientific Title

Effect of acupuncture on xerostomia by radiotherapy for head and neck cancer

Scientific Title:Acronym

Effect of acupuncture on xerostomia by radiotherapy for head and neck cancer

Region

Japan


Condition

Condition

head and neck cancer

Classification by specialty

Oto-rhino-laryngology Radiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

effect of the electroacupuncture to xerostomia by radiotherapy of the head and neck cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

valuation of subjective symptoms by visual analog scale

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

low frequency electroacupuncture
8 times on a weekly basis

Interventions/Control_2

medium frequency electroacupuncture
8 times on a weekly basis

Interventions/Control_3

no treatment group (observation)

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

Male and Female

Key inclusion criteria

1) Patients more than 20 years old.
2) During 3-12 months after radiation therapy.
3) Patients with xerostomia after radiation.
4) Dermatitis and stomatitis free after radiation therapy.
5) With written consent from the person.

Key exclusion criteria

1) There is dermatitis and stomatitis still as a side effect of radiation therapy for head and neck cancer.
2) Removal of salivary glands.
3) Case with xerostomia before radiation therapy (such as Sjogrens syndrome).
4) Psychiatric disorders.
5) Case physician decided inappropriate.

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Toshinori Ito

Organization

Osaka University Graduate School of Medicine

Division name

Department of Integrative Medicine

Zip code


Address

2-2, Yamadaoka, Suita, Osaka

TEL

06-6879-3498

Email

juki@cam.med.osaka-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Keiko Ashihara

Organization

Osaka University Graduate School of Medicine

Division name

Department of Integrative Medicine

Zip code


Address

2-2, Yamadaoka, Suita, Osaka

TEL

06-6879-3498

Homepage URL


Email

k-ashihara@cam.med.osaka-u.ac.jp


Sponsor or person

Institute

Department of Integrative Medicine, Osaka University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Japan Agency for Medical Research and Development

Organization

Division

Category of Funding Organization

Government offices of other countries

Nationality of Funding Organization



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



Other administrative information

Date of disclosure of the study information

2016 Year 05 Month 20 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


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

Preinitiation

Date of protocol fixation

2016 Year 04 Month 13 Day

Date of IRB


Anticipated trial start date

2016 Year 05 Month 16 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 05 Month 10 Day

Last modified on

2016 Year 05 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024061


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name