Unique ID issued by UMIN | UMIN000012736 |
---|---|
Receipt number | R000014882 |
Scientific Title | Crossover, pilot study of the effect of nutritional intervention with elemental diet on digestive symptom and nutritional status during concurrent chemoradiotherapy for head and neck cancer. |
Date of disclosure of the study information | 2013/12/31 |
Last modified on | 2016/05/17 10:59:26 |
Crossover, pilot study of the effect of nutritional intervention with elemental diet on digestive symptom and nutritional status during concurrent chemoradiotherapy for head and neck cancer.
Pilot study of nutritional intervention in concurrent chemoradiotherapy for head and neck cancer.
Crossover, pilot study of the effect of nutritional intervention with elemental diet on digestive symptom and nutritional status during concurrent chemoradiotherapy for head and neck cancer.
Pilot study of nutritional intervention in concurrent chemoradiotherapy for head and neck cancer.
Japan |
Head and neck cancer
Oto-rhino-laryngology |
Malignancy
NO
To evaluate significance of nutritional intervention with elemental diet by crossover style in the same patient during concurrent chemoradiotherapy for head and neck cancer.
Pharmacodynamics
Exploratory
Pragmatic
Phase II
Change of nutritional status during chemoradiotherapy, serum albumin
1)Physical examination, blood biochemistries
2)Adverse events
Interventional
Cross-over
Non-randomized
Open -no one is blinded
No treatment
2
Treatment
Medicine |
Elemental diet (300kcal/day) administration in first course of chemoradiotherapy, and no administration in second course
No administration of elemental diet in first course of chemoradiotherapy, and elemental diet administration (300kcal/day) in second course
20 | years-old | <= |
Not applicable |
Male and Female
1.Patients with head and neck cancer who will undergo radiotherapy.
2.Patient age at the time of obtaining informed consent is 20 years of age or older.
3.Written informed consent.
1.Past history of serious drug hypersensitivity.
2.Severe diabetes or possibility of glucose metabolism abnormality due to high-dose steroid treatment.
3.Abnormality in amino acid metabolism.
4.Pregnant or nursing women and those with the possibility of pregnancy.
5.Participation judged by physician to be inadvisable.
40
1st name | |
Middle name | |
Last name | Kiyoaki Tsukahara |
Tokyo Medical University Hachioji Medical Center
Otorhinoryngology, Head and Neck surgery
1163 Taktemachi Hachioji-shi Tokyo
042-665-5611
tsuka@tokyo-med.ac.jp
1st name | |
Middle name | |
Last name | Kiyoaki Tsukahara |
Tokyo Medical University Hachioji Medical Center
Otorhinoryngology, Head and Neck surgery
1163 Taktemachi Hachioji-shi Tokyo
042-665-5611
tsuka@tokyo-med.ac.jp
Tokyo Medical University Hachioji Medical Center
None
Self funding
NO
東京医科大学八王子医療センター(東京都)
2013 | Year | 12 | Month | 31 | Day |
Unpublished
Completed
2012 | Year | 09 | Month | 06 | Day |
2012 | Year | 09 | Month | 06 | Day |
2015 | Year | 07 | Month | 31 | Day |
2013 | Year | 12 | Month | 31 | Day |
2016 | Year | 05 | Month | 17 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014882
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |