UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039935 |
|---|---|
| Receipt number | 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 | 2024/03/28 17:06:22 |
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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
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
ryusuke.s.0415@gmail.com
Sponsor or person
Institute
Niigata University
Institute
Department
Personal name
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
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
29
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
| 2020 | Year | 02 | Month | 12 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 12 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2024 | 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
| 2024 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045495
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