Unique ID issued by UMIN | UMIN000028021 |
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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 |
Correlation between radiation doses and salivary gland function preservation associated with radiotherapy for patients with head and neck cancer using salivary gland scintigraphy
Correlation between radiation dose and salivary gland secretion associated with radiotherapy
Correlation between radiation doses and salivary gland function preservation associated with radiotherapy for patients with head and neck cancer using salivary gland scintigraphy
Correlation between radiation dose and salivary gland secretion associated with radiotherapy
Japan |
head and neck cancer
Radiology |
Malignancy
NO
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.
Others
Translational study: Evaluation of predictive and prognostic factors
Exploratory
Others
Not applicable
To assess the scores of salivary gland secretion amounts and recovery rates by the salivary gland scintigraphy before and after radiotherapy
Observational
20 | years-old | <= |
Not applicable |
Male and Female
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
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
50
1st name | Tomohiro |
Middle name | |
Last name | Itonaga |
Tokyo Medical University
Department of radiology
160-0023
6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo 160-0023
0333426111
itonaga@tokyo-med.ac.jp
1st name | Tomohiro |
Middle name | |
Last name | Itonaga |
Tokyo Medical University
Department of radiology
160-0023
6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo 160-0023
0333426111
itonaga@tokyo-med.ac.jp
Department of radiology,Tokyo Medical University
Department of radiology,Tokyo Medical University
Self funding
IRB committee, Tokyo Medical University
6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo 160-0023
03-3342-6111
IRB@tokyo-med.ac.jp
NO
東京医科大学病院(東京都)
2017 | Year | 07 | Month | 01 | Day |
https://doi.org/10.1259/bjr.20210718
Published
https://doi.org/10.1259/bjr.20210718
31
In this study, the average tolerated dose to the salivary glands was 46 Gy.
2022 | Year | 01 | Month | 04 | Day |
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.
No randomization study
Fifty-seven patients were enrolled in the study, and 31 patients underwent total thrice salivary gland scintigraphy.
This study is observational study.
In this study, we used salivary scintigraphy to mathematically investigate the tolerance dose of radiotherapy in the salivary gland.
Main results already published
2017 | Year | 04 | Month | 25 | Day |
2017 | Year | 04 | Month | 25 | Day |
2017 | Year | 07 | Month | 01 | Day |
2020 | Year | 02 | Month | 28 | Day |
2021 | Year | 03 | Month | 31 | Day |
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.
2017 | Year | 06 | Month | 30 | Day |
2022 | Year | 01 | Month | 04 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031838
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