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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000039935
Receipt No. R000045495
Scientific Title Evaluation on suppression of skeletal muscle mass decrease by exercise intervention in head and neck cancer chemoradiotherapy patients
Date of disclosure of the study information 2020/04/01
Last modified on 2020/03/20

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Basic information
Public title Evaluation on suppression of skeletal muscle mass decrease by exercise intervention in head and neck cancer chemoradiotherapy patients
Acronym Evaluation on suppression of skeletal muscle mass decrease by exercise intervention in head and neck cancer chemoradiotherapy patients
Scientific Title Evaluation on suppression of skeletal muscle mass decrease by exercise intervention in head and neck cancer chemoradiotherapy patients
Scientific Title:Acronym Evaluation on suppression of skeletal muscle mass decrease by exercise intervention in head and neck cancer chemoradiotherapy patients
Region
Japan

Condition
Condition Head and neck cancer
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The object of this study is to evaluate the preventive effect of skeletal muscle mass loss during treatment on head and neck cancer chemoradiotherapy with exercise intervention.
Basic objectives2 Others
Basic objectives -Others Exercise intervention and nutritional support are provided for head and neck cancer chemoradiotherapy patients. Skeletal muscle mass is measured by BIA method before and after treatment. Assess the preventive effect of skeletal muscle loss, in comparison with past cases without intervention.
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Changes of skeletal muscle mass
Key secondary outcomes Chemoradiotherapy completion rate, adverse events, PG-SGA, Clinical biochemistry and hematology, motor function evaluation

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Educational,Counseling,Training
Type of intervention
Food Behavior,custom
Interventions/Control_1 Conduct exercise therapy intervention 5 times a week for 7 weeks. Exercise therapy includes stretching, resistance training, endurance training. Provide nutritional support for foods containing 6 g of BCAA per day, taking into energy of consumed during exercise.
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

Not applicable
Gender Male and Female
Key inclusion criteria Head and neck cancer patients diagnosed by histology or cytology who undergo chemoradiotherapy with cisplatin as first-line treatment.
Patients with written informed consent has been obtained.
Patients who can receive the regimen of cisplatin 80mg /m2 every 3 weeks.
ECOG Performance status is 0, 1 or 2.
Patients with sufficient liver, kidney and bone marrow functions are maintained. Patients with white blood cell count 3,000 / mm3 or more, platelet count 100000 /mm3 or more, less than twice the AST facility standard upper limit, less than twice the ALT facility standard upper limit, eGFR 40 ml / min or more.
Key exclusion criteria Patients not for curative treatment.
Patients with pacemaker implantation.
Patients with chemoradiotherapy after induction chemotherapy.
Patients with chemoradiotherapy as adjuvant therapy.
Patients determined by the attending physician to be inappropriate.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Ryusuke
Middle name
Last name Shodo
Organization Niigata University
Division name Department of Otorhinolaryngology, Head and Neck Surgery
Zip code 951-8510
Address Asahimachi 1-757, Chuo-ku, Niigata, Niigata, Japan
TEL 025-227-2306
Email ryusuke.s.0415@gmail.com

Public contact
Name of contact person
1st name Ryusuke
Middle name
Last name Shodo
Organization Niigata University
Division name Department of Otorhinolaryngology, Head and Neck Surgery
Zip code 951-8510
Address Asahimachi 1-757, Chuo-ku, Niigata, Niigata, Japan
TEL 025-227-2306
Homepage URL
Email ryusuke.s.0415@gmail.com

Sponsor
Institute Niigata University
Institute
Department

Funding Source
Organization Otsuka Pharmaceutical Factory, Inc.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Niigata University Medical and Dental Hospital
Address Asahimachi 1, Chuo-ku, Niigata, Niigata, Japan
Tel 025-227-2625
Email ethics@adm.niigata-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
2020 Year 04 Month 01 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 Preinitiation
Date of protocol fixation
2020 Year 02 Month 12 Day
Date of IRB
Anticipated trial start date
2020 Year 04 Month 01 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 03 Month 25 Day
Last modified on
2020 Year 03 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045495

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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