UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000037119
Receipt No. R000042294
Scientific Title Effects of different breathing methods on dose distribution in carbon ion radiotherapy for head and neck cancer
Date of disclosure of the study information 2019/06/30
Last modified on 2019/06/19

* 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 Effects of different breathing methods on dose distribution in carbon ion radiotherapy for head and neck cancer
Acronym Effects of different breathing methods on dose distribution in carbon ion radiotherapy for head and neck cancer
Scientific Title Effects of different breathing methods on dose distribution in carbon ion radiotherapy for head and neck cancer
Scientific Title:Acronym Effects of different breathing methods on dose distribution in carbon ion radiotherapy for head and neck cancer
Region
Japan

Condition
Condition head and neck cancer
Classification by specialty
Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 In this study, we will clarify the effects of different breathing methods by mouth breathing and nasal breathing on dose distribution in head and neck cancer patients undergoing carbon ion radiotherapy at QST hospital.
Basic objectives2 Others
Basic objectives -Others In this study, we will clarify the effects of different breathing methods by mouth breathing and nasal breathing on dose distribution in head and neck cancer patients undergoing carbon ion radiotherapy at QST hospital.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Dose to tongue and soft palate, dose to risk organs such as pharyngeal mucosa and spinal cord, dose to gross tumor volume and planned target volume in DVH analysis
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Mouth breathe
Interventions/Control_2 Nose breathe
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Histologically confirmed head and neck cancer
Patients who undergo carbon ion radiotherapy in QST hospital
patients who are expected to include the soft palate and tongue in the radiation field.
patients who cannnot use the tongue depressor
Key exclusion criteria Other medical or psychological unsuitable reasons
There are significant metal artifacts on the treatment planning CT images.
Patients with nasal cavity or oral cavity who have difficulty breathing with either nasal or mouth breathing.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Hiroaki
Middle name
Last name Ikawa
Organization National Institutes for Quantum and Radiological Science and Technology
Division name QST Hospital
Zip code 263-8555
Address 4-9-1 Anagawa, Inage-ku, Chiba, 263-8555, Japan.
TEL 043-206-3306
Email ikawa.hiroaki@qst.go.jp

Public contact
Name of contact person
1st name Hiroaki
Middle name
Last name Ikawa
Organization National Institutes for Quantum and Radiological Science and Technology
Division name QST Hospital
Zip code 263-8555
Address 4-9-1 Anagawa, Inage-ku, Chiba, 263-8555, Japan.
TEL 043-206-3306
Homepage URL
Email ikawa.hiroaki@qst.go.jp

Sponsor
Institute National Institutes for Quantum and Radiological Science and Technology
Institute
Department

Funding Source
Organization National Institutes for Quantum and Radiological Science and Technology
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization National Institutes for Quantum and Radiological Science and Technology
Address 4-9-1 Anagawa, Inage-ku, Chiba, 263-8555, Japan.
Tel 043-206-3306
Email ikawa.hiroaki@qst.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

Other administrative information
Date of disclosure of the study information
2019 Year 06 Month 30 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 Enrolling by invitation
Date of protocol fixation
2019 Year 04 Month 23 Day
Date of IRB
2019 Year 05 Month 31 Day
Anticipated trial start date
2019 Year 07 Month 01 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 06 Month 20 Day
Last modified on
2019 Year 06 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042294

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.