UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effects of rehabilitation to pat ients with head and neck cancer during chemoradiotherapy
Title of the study (Brief title)	The effects of rehabilitation to pat ients with head and neck cancer during chemoradiotherapy
Region	Japan

Condition
Condition	Head and neck cancer
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The purpose is to evaluate wheth er nutrition status, swallowing fun ction, muscle strength and QOL c ould be improved by the intervent ion of nutrition support and exerc ise therapy on patients with head and neck cancer suffering from th e chemoradiation therapy.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	nutritional status, muscular streng th, health related QOL, and depre ssion scale
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	nutritional support by nutrition support team (NST)
Interventions/Control_2	nutrition support by NST plus exercise therapy
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	patients with head and neck canc er The first therapy is a chemoradiat ion without operation.
Key exclusion criteria	patients with paresis, heart diseas e, severe hypertension, and/or str oke
Target sample size	50

Research contact person
Name of lead principal investigator	Takashi Mizushima
Organization	Hamamatsu University Hospital
Division name	Division of Rehabilitation
Address	1-20-1 Handayama East Ward, Hamamatsu, Shizuoka, Japan
TEL	053-435-2111
Email	mizusima@hama-med.ac.jp

Public contact
Name of contact person	Chisato Yasuda
Organization	Hamamatsu University Hospital
Division name	Division of Rehabilitation
Address	1-20-1 Handayama East Ward, Hamamatsu, Shizuoka, Japan
TEL	053-435-2111
Homepage URL
Email	chisatoy@hama-med.ac.jp

Sponsor
Institute	Hamamatsu University School of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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

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

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 07 Month 20 Day

Progress
Recruitment status	Recruiting
Date of protocol fixation	2016 Year 04 Month 01 Day
Anticipated trial start date	2016 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	nothing particular

Management information
Registered date	2016 Year 07 Month 20 Day
Last modified on	2016 Year 07 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026778