UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020482
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title L-carnitine supplementation for the treatment of chemoradiotherapy-induced fatigue in patients with head and neck cancer
Acronym L-carnitine supplementation for the treatment in patients with head and neck cancer
Scientific Title L-carnitine supplementation for the treatment of chemoradiotherapy-induced fatigue in patients with head and neck cancer
Scientific Title:Acronym L-carnitine supplementation for the treatment in patients with head and neck cancer
Region
Japan

Condition
Condition head and neck cancer
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We examine that levocarnitine supplementation for the treatment of chemotherapy-induced fatigue in head and neck cancer
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes to alleviate cancer-related fatigue in patients receiving chemoradiotherapy at the time after chemo-radiation therapy
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 supplementation of L-carnitine, 7 weeks, 1 time/everyday, 1000mg
Interventions/Control_2 control, nothing to treat
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria patient with head and neck cancer recieving CDDP-based chemoradiotherapy
Key exclusion criteria severe liver disfunction
sereve kidney disfunction
Diabetic patient
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomokazu Yoshizaki
Organization Kanazawa University Hospital
Division name Otolaryngology
Zip code
Address 13-1 Takara-machi Kanazawa city Isikawa
TEL 81-76-265-2413
Email endok@med.kanazawa-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuhira Endo
Organization Kanazawa University Hospital
Division name Otolaryngology
Zip code
Address 13-1 Takara-machi, Kanazawa city, Ishikawa
TEL 81-76-265-2413
Homepage URL
Email endok@med.kanazawa-u.ac.jp

Sponsor
Institute Kanazawa University Hospital
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2016 Year 01 Month 07 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2014 Year 07 Month 24 Day
Date of IRB
Anticipated trial start date
2014 Year 08 Month 01 Day
Last follow-up date
2018 Year 03 Month 31 Day
Date of closure to data entry
2018 Year 03 Month 31 Day
Date trial data considered complete
2018 Year 03 Month 31 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 01 Month 07 Day
Last modified on
2018 Year 07 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023649

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.