UMIN-CTR Clinical Trial

Basic information
Public title	Prognostic significance of sarcopenia in patients treated with surgery or radiotherapy for head and neck cancer: A meta-analysis
Acronym	effect of sarcopenia on head and neck cancer treatment
Scientific Title	Prognostic significance of sarcopenia in patients treated with surgery or radiotherapy for head and neck cancer: A meta-analysis
Scientific Title:Acronym	sarcopenia and 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	To investigate the prognostic impact of sarcopenia on head and neck cancer
Basic objectives2	Others
Basic objectives -Others	effect on oncologic outcomes
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	overall survival
Key secondary outcomes	disease-specific survival, disease-free survival

Base
Study type	Others,meta-analysis etc

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	studies regarding the effect of sarcopenia on treatment outcomes in head and neck cancer Treatment for head and neck cancer is either curative intent surgery or radiotherapy.
Key exclusion criteria	studies investigating nasopharyngeal carcinoma or thyroid cancer hazard ratios are not available non-human studies reviews conference abstracts
Target sample size

Research contact person
Name of lead principal investigator	1st name takenaka Middle name Last name yukinori
Organization	Osaka university graduate school of medicine
Division name	department of otorhinolaryngology-head and neck surgery
Zip code	5650871
Address	2-2 yamadaoka, suita, osaka
TEL	+81-6-6879-3951
Email	ytakenaka@ent.med.osaka-u.ac.jp

Public contact
Name of contact person	1st name takenaka Middle name Last name yukinori
Organization	Osaka university graduate school of medicine
Division name	department of otorhinolaryngology-head and neck surgery
Zip code	5650871
Address	2-2 yamadaoka, suita, osaka
TEL	+81-6-6879-3951
Homepage URL
Email	ytakenaka@ent.med.osaka-u.ac.jp

Sponsor
Institute	osaka university
Institute
Department

Funding Source
Organization	self-funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	osaka university
Address	2-2 yamadaoka, suita, osaka
Tel	0662108290
Email	rinri@hp-crc.med.osaka-u.ac.jp

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	2021 Year 02 Month 01 Day

Related information
URL releasing protocol	https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0259288
Publication of results	Unpublished

Result
URL related to results and publications	https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0259288
Number of participants that the trial has enrolled	3233
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	Completed
Date of protocol fixation	2021 Year 02 Month 01 Day
Date of IRB	2021 Year 06 Month 01 Day
Anticipated trial start date	2021 Year 02 Month 01 Day
Last follow-up date	2021 Year 06 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Literature search is to be done on 2/1/2021. Statistical analyses is to be done by 6/1/2021.

Management information
Registered date	2021 Year 01 Month 26 Day
Last modified on	2022 Year 04 Month 16 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049076