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

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 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


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

Value
https://center6.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