Unique ID issued by UMIN | UMIN000024910 |
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Receipt number | R000027981 |
Scientific Title | Evaluation of the relation between carnitine deficiency and fatigue in patients with head and neck carcinoma under induction chemotherapy |
Date of disclosure of the study information | 2019/12/31 |
Last modified on | 2021/06/24 10:34:12 |
Evaluation of the relation between carnitine deficiency and fatigue in patients with head and neck carcinoma under induction chemotherapy
Evaluation of the relation between carnitine deficiency and fatigue in patients with head and neck carcinoma under induction chemotherapy
Evaluation of the relation between carnitine deficiency and fatigue in patients with head and neck carcinoma under induction chemotherapy
Evaluation of the relation between carnitine deficiency and fatigue in patients with head and neck carcinoma under induction chemotherapy
Japan |
Head and Neck carcinoma
Oto-rhino-laryngology |
Malignancy
NO
The Objects is to evaluate of relationship with serum carnitine levels and baseline of patients such as muscle and fat mass, glucose and fat metabolism, liver function in patients with untreated head and neck carcinoma.
Others
The influence of induction chemotherapy to serum carnitine concentration before and after induction chemotherapy by docetaxel, cisplatine and 5-FU. The complementary objects of this study is to assess the correlation of serum carnitine levels and fatigue, and to reserch the cause of carnitine deficiency.
Exploratory
Not applicable
Serum carnitine levels include free body, acyl body and total before and after induction chemotherapy
Fatigue used VAS scale before and after induction chemotherapy.
Body component include body weight, volume of skeletal muscle and fat, BMI, BCM and AC% used In Body.
Volume of skeletal muscle and fat used computed tomography.
Clinical biochemistry and hematology include AST, ALT, ALP, Alb, T-Bil, BUN, Cr, PLT, PT(s), TP, T-Cho, Ch-E, TG, FFA, Pr-Alb, CRP, blood glucose level,RBC, WBC, Hb.
Observational
20 | years-old | <= |
75 | years-old | > |
Male and Female
Patient with untreated head and neck carcinoma and receiving individualized treatment regimens of Docetaxel, Cisplatin and 5FU as developed.
StageI, II, III and IVA
ECOG PS 1 and 2
Patients with hypersensitivity to levocarnitine.
Patients who takes levocarnitine within one month from the present.
Pregnant female and nursing female.
Patient that informed concent is not provided.
Patient with sereous renal failure
Patient with insulin dependent diabetes mellitus, diabetic ketoacidosis and metabolic acitosis
20
1st name | |
Middle name | |
Last name | Kiyoaki Tsukahara |
Tokyo Medical University
Department of Otorhinolaryngology, Head and Neck Surgery
6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo, Japan
03-3346-9275
tsuka@tokyo-med.ac.jp
1st name | |
Middle name | |
Last name | Hiroki Sato |
Tokyo Medical University
Department of Otorhinolaryngology, Head and Neck Surgery
6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo, Japan
03-3346-9275
satohiro1979@yahoo.co.jp
Tokyo Medical University
Tokyo Medical University
Other
NO
東京医科大学病院
2019 | Year | 12 | Month | 31 | Day |
Unpublished
No longer recruiting
2016 | Year | 10 | Month | 05 | Day |
2016 | Year | 08 | Month | 20 | Day |
2016 | Year | 10 | Month | 11 | Day |
2020 | Year | 12 | Month | 31 | Day |
none
2016 | Year | 11 | Month | 19 | Day |
2021 | Year | 06 | Month | 24 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027981
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