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carnitine supplementation for the treatment of chemoradiotherapy-induced fatigue in patients with head and neck cancer

Not Applicable
Conditions
head and neck cancer
Registration Number
JPRN-UMIN000020482
Lead Sponsor
Kanazawa University Hospital
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
50
Inclusion Criteria

Not provided

Exclusion Criteria

severe liver disfunction sereve kidney disfunction Diabetic patient

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
to alleviate cancer-related fatigue in patients receiving chemoradiotherapy at the time after chemo-radiation therapy
Secondary Outcome Measures
NameTimeMethod
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