UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020482 |
|---|---|
| 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 |
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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
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
endok@med.kanazawa-u.ac.jp
Sponsor or person
Institute
Kanazawa University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023649
