UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028021 |
|---|---|
| Receipt number | R000031838 |
| Scientific Title | Correlation between radiation doses and salivary gland function preservation associated with radiotherapy for patients with head and neck cancer using salivary gland scintigraphy |
| Date of disclosure of the study information | 2017/07/01 |
| Last modified on | 2022/01/04 10:09:12 |
* 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
Correlation between radiation doses and salivary gland function preservation associated with radiotherapy for patients with head and neck cancer using salivary gland scintigraphy
Acronym
Correlation between radiation dose and salivary gland secretion associated with radiotherapy
Scientific Title
Correlation between radiation doses and salivary gland function preservation associated with radiotherapy for patients with head and neck cancer using salivary gland scintigraphy
Scientific Title:Acronym
Correlation between radiation dose and salivary gland secretion associated with radiotherapy
Region
| Japan |
Condition
Condition
head and neck cancer
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the correlation between radiation doses and salivary gland functions in patients with head and neck cancer treated with whole neck radiotherapy. Salivary gland scintigraphy is performed three times before radiotherapy, and three months after the initiation of radiotherapy and then one year after.
Basic objectives2
Others
Basic objectives -Others
Translational study: Evaluation of predictive and prognostic factors
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
To assess the scores of salivary gland secretion amounts and recovery rates by the salivary gland scintigraphy before and after radiotherapy
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
Male and Female
Key inclusion criteria
1) Pathologically proven as head and neck cancer patients over 20 years of age.
2) Patients with preserved salivary gland functions
3) Patient with Performance Status of 0-1.
4) Patients without autoimmune diseases, such as Sjogren's syndrome
5) Patients who are able to provide written informed consents
Key exclusion criteria
1) Prognosis is expected to be less than 6 months
2) Suffering from severe underlying diseases, such as liver cirrhosis, diabetes mellitus and heart diseases
3) Suffering from severe allergic reactions to drugs
4) Pregnant or breast-feeding women, or women who may become or want to become pregnant in the near future
5) No previous history of receiving whole neck radiotherapy
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Tomohiro |
| Middle name | |
| Last name | Itonaga |
Organization
Tokyo Medical University
Division name
Department of radiology
Zip code
160-0023
Address
6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo 160-0023
TEL
0333426111
itonaga@tokyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Tomohiro |
| Middle name | |
| Last name | Itonaga |
Organization
Tokyo Medical University
Division name
Department of radiology
Zip code
160-0023
Address
6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo 160-0023
TEL
0333426111
Homepage URL
itonaga@tokyo-med.ac.jp
Sponsor or person
Institute
Department of radiology,Tokyo Medical University
Institute
Department
Personal name
Funding Source
Organization
Department of radiology,Tokyo Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB committee, Tokyo Medical University
Address
6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo 160-0023
Tel
03-3342-6111
IRB@tokyo-med.ac.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
東京医科大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
https://doi.org/10.1259/bjr.20210718
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1259/bjr.20210718
Number of participants that the trial has enrolled
31
Results
In this study, the average tolerated dose to the salivary glands was 46 Gy.
Results date posted
| 2022 | Year | 01 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Xerostomia is the most common treatment-related toxicity after radiotherapy (RT) for head and neck carcinoma, reducing the quality of life of patients due to a decrease in salivary gland function.
Participant flow
No randomization study
Fifty-seven patients were enrolled in the study, and 31 patients underwent total thrice salivary gland scintigraphy.
Adverse events
This study is observational study.
Outcome measures
In this study, we used salivary scintigraphy to mathematically investigate the tolerance dose of radiotherapy in the salivary gland.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2017 | Year | 04 | Month | 25 | Day |
Date of IRB
| 2017 | Year | 04 | Month | 25 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2021 | Year | 03 | Month | 31 | Day |
Other
Other related information
Registration period is determined to be two years. The follow up period is set to be another 1 year from the end of the radiotherapy, so in total 3 years will be necessary.
Management information
Registered date
| 2017 | Year | 06 | Month | 30 | Day |
Last modified on
| 2022 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031838
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
