Unique ID issued by UMIN | UMIN000020482 |
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Receipt number | R000023649 |
Scientific Title | L-carnitine supplementation for the treatment of chemoradiotherapy-induced fatigue in patients with head and neck cancer |
Date of disclosure of the study information | 2016/01/07 |
Last modified on | 2018/07/12 13:36:13 |
L-carnitine supplementation for the treatment of chemoradiotherapy-induced fatigue in patients with head and neck cancer
L-carnitine supplementation for the treatment in patients with head and neck cancer
L-carnitine supplementation for the treatment of chemoradiotherapy-induced fatigue in patients with head and neck cancer
L-carnitine supplementation for the treatment in patients with head and neck cancer
Japan |
head and neck cancer
Oto-rhino-laryngology |
Malignancy
NO
We examine that levocarnitine supplementation for the treatment of chemotherapy-induced fatigue in head and neck cancer
Efficacy
to alleviate cancer-related fatigue in patients receiving chemoradiotherapy at the time after chemo-radiation therapy
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
No treatment
2
Treatment
Food |
supplementation of L-carnitine, 7 weeks, 1 time/everyday, 1000mg
control, nothing to treat
20 | years-old | <= |
Not applicable |
Male and Female
patient with head and neck cancer recieving CDDP-based chemoradiotherapy
severe liver disfunction
sereve kidney disfunction
Diabetic patient
50
1st name | |
Middle name | |
Last name | Tomokazu Yoshizaki |
Kanazawa University Hospital
Otolaryngology
13-1 Takara-machi Kanazawa city Isikawa
81-76-265-2413
endok@med.kanazawa-u.ac.jp
1st name | |
Middle name | |
Last name | Kazuhira Endo |
Kanazawa University Hospital
Otolaryngology
13-1 Takara-machi, Kanazawa city, Ishikawa
81-76-265-2413
endok@med.kanazawa-u.ac.jp
Kanazawa University Hospital
Ministry of Education, Culture, Sports, Science and Technology
Japanese Governmental office
NO
2016 | Year | 01 | Month | 07 | Day |
Published
Cancer-related fatigue impairs daily functioning and negatively impacts health-related quality of life (HRQoL). Our previous study revealed that cisplatin-based chemoradiotherapy (CRT) impairs the carnitine system and carnitine deficiency leads to poor physical functioning. This open label, randomized, controlled prospective study investigated the effects of L-carnitine administration on plasma carnitine concentration, CRT-induced fatigue, and decline in HRQoL in patients with head and neck squamous cell carcinoma (HNSCC). Patients were divided into experimental group (received 1000 mg of oral liquid L-carnitine once daily for 8 weeks) and control group. The primary and secondary endpoints were the change in HRQoL scores and the change in carnitine levels, respectively, from baseline (pre-CRT) to after CRT. The mean total plasma carnitine concentration in the control group decreased significantly, 2 weeks after the end of chemotherapy, while no significant differences were seen in the L-carnitine group. L-carnitine administration, therefore, kept the physical functioning score unchanged. Our study shows that patients who receive CRT experience chemotherapy-induced damage of carnitine homeostasis leading to deficiency of carnitine and impairment of HRQoL. L-carnitine administration is beneficial in improving the HRQoL in patients with HNSCC.
Completed
2014 | Year | 07 | Month | 24 | Day |
2014 | Year | 08 | Month | 01 | Day |
2018 | Year | 03 | Month | 31 | Day |
2018 | Year | 03 | Month | 31 | Day |
2018 | Year | 03 | Month | 31 | Day |
2016 | Year | 01 | Month | 07 | Day |
2018 | Year | 07 | Month | 12 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023649
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