UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000023238
Receipt No. R000026778
Scientific Title The effects of rehabilitation to pat ients with head and neck cancer during chemoradiotherapy
Date of disclosure of the study information 2016/07/20
Last modified on 2016/07/20

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title The effects of rehabilitation to pat
ients with head and neck cancer
during chemoradiotherapy
Acronym The effects of rehabilitation to pat
ients with head and neck cancer
during chemoradiotherapy
Scientific Title The effects of rehabilitation to pat
ients with head and neck cancer
during chemoradiotherapy
Scientific Title:Acronym 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

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

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
1st name
Middle name
Last name Takashi Mizushima
Organization Hamamatsu University Hospital
Division name Division of Rehabilitation
Zip code
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
1st name
Middle name
Last name Chisato Yasuda
Organization Hamamatsu University Hospital
Division name Division of Rehabilitation
Zip code
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

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)

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 07 Month 20 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
Date of protocol fixation
2016 Year 04 Month 01 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.