UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of the relation between carnitine deficiency and fatigue in patients with head and neck carcinoma under induction chemotherapy
Acronym	Evaluation of the relation between carnitine deficiency and fatigue in patients with head and neck carcinoma under induction chemotherapy
Scientific Title	Evaluation of the relation between carnitine deficiency and fatigue in patients with head and neck carcinoma under induction chemotherapy
Scientific Title:Acronym	Evaluation of the relation between carnitine deficiency and fatigue in patients with head and neck carcinoma under induction chemotherapy
Region	Japan

Condition
Condition	Head and Neck carcinoma
Classification by specialty	Oto-rhino-laryngology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The Objects is to evaluate of relationship with serum carnitine levels and baseline of patients such as muscle and fat mass, glucose and fat metabolism, liver function in patients with untreated head and neck carcinoma.
Basic objectives2	Others
Basic objectives -Others	The influence of induction chemotherapy to serum carnitine concentration before and after induction chemotherapy by docetaxel, cisplatine and 5-FU. The complementary objects of this study is to assess the correlation of serum carnitine levels and fatigue, and to reserch the cause of carnitine deficiency.
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Serum carnitine levels include free body, acyl body and total before and after induction chemotherapy
Key secondary outcomes	Fatigue used VAS scale before and after induction chemotherapy. Body component include body weight, volume of skeletal muscle and fat, BMI, BCM and AC% used In Body. Volume of skeletal muscle and fat used computed tomography. Clinical biochemistry and hematology include AST, ALT, ALP, Alb, T-Bil, BUN, Cr, PLT, PT(s), TP, T-Cho, Ch-E, TG, FFA, Pr-Alb, CRP, blood glucose level,RBC, WBC, Hb.

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	75 years-old >
Gender	Male and Female
Key inclusion criteria	Patient with untreated head and neck carcinoma and receiving individualized treatment regimens of Docetaxel, Cisplatin and 5FU as developed. StageI, II, III and IVA ECOG PS 1 and 2
Key exclusion criteria	Patients with hypersensitivity to levocarnitine. Patients who takes levocarnitine within one month from the present. Pregnant female and nursing female. Patient that informed concent is not provided. Patient with sereous renal failure Patient with insulin dependent diabetes mellitus, diabetic ketoacidosis and metabolic acitosis
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kiyoaki Tsukahara
Organization	Tokyo Medical University
Division name	Department of Otorhinolaryngology, Head and Neck Surgery
Zip code
Address	6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo, Japan
TEL	03-3346-9275
Email	tsuka@tokyo-med.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Hiroki Sato
Organization	Tokyo Medical University
Division name	Department of Otorhinolaryngology, Head and Neck Surgery
Zip code
Address	6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo, Japan
TEL	03-3346-9275
Homepage URL
Email	satohiro1979@yahoo.co.jp

Sponsor
Institute	Tokyo Medical University
Institute
Department

Funding Source
Organization	Tokyo Medical University
Organization
Division
Category of Funding Organization	Other
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	東京医科大学病院

Other administrative information
Date of disclosure of the study information	2019 Year 12 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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	No longer recruiting
Date of protocol fixation	2016 Year 10 Month 05 Day
Date of IRB	2016 Year 08 Month 20 Day
Anticipated trial start date	2016 Year 10 Month 11 Day
Last follow-up date	2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	none

Management information
Registered date	2016 Year 11 Month 19 Day
Last modified on	2021 Year 06 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027981