UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004738 |
|---|---|
| Receipt number | R000005469 |
| Scientific Title | The effects of active nutritional support to patients with head and neck cancer during concurrent chemoradiotherapy |
| Date of disclosure of the study information | 2010/12/16 |
| Last modified on | 2016/02/07 10:14:39 |
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Basic information
Public title
The effects of active nutritional support to patients with head and neck cancer during concurrent chemoradiotherapy
Acronym
The effects of active nutritional support to patients with head and neck cancer during concurrent chemoradiotherapy
Scientific Title
The effects of active nutritional support to patients with head and neck cancer during concurrent chemoradiotherapy
Scientific Title:Acronym
The effects of active nutritional support to patients with head and neck cancer during concurrent chemoradiotherapy
Region
| Japan |
Condition
Condition
head and neck cancer(nasopharyngeal carcinoma, oropharyngeal carcinoma, hypopharyngeal carcinoma, supraglottic laryngeal carcinoma, cancers of the oral cavity)
Classification by specialty
| Surgery in general | Oto-rhino-laryngology | Radiology |
| Oral surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the effects on extent of weight loss, nutritional status, treatment completion rate and adverse event rate by supplementation of calculated nutritional energy intake during concurrent chemoradiotherapy for head and neck cancer.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Percent change of body weight loss during chemoradiotherapy
Key secondary outcomes
1)Physical examination, blood test
2)immune status index
3)treatment completion rate
4)occurrence of adverse events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Behavior,custom |
Interventions/Control_1
For the interventional group, daily nutritional energy will be calculated by multiplying the BEE by the activity factor (1.2) and the stress factor (1.5). The calculated energy will be administered basically by oral food intake during chemoradiotherapy, but the enteral feeding formula (RacolⓇ) will be supplied in the case of insufficient intake.
Interventions/Control_2
For the control group, daily nutritional energy will be calculated by multiplying the BEE by the activity factor (1.2) and the stress factor (1.1). The calculated energy will be administered basically by oral food intake during chemoradiotherapy
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)patients with head and neck cancer (nasopharyngeal carcinoma, oropharyngeal carcinoma, hypopharyngeal carcinoma, oral cavity carcinoma, supraglottic carcinoma)
2)clinical stage: II, III, IVA, IVB
3)PS=0, 1, 2
4)Leukocyte count>3,000/mm3
5)Platelet count>10x104/mm3
6)Hemoglobin>10g/dL
7)AST(GOT)<2.0 times the upper limit of normal at hospital
8)ALT(GPT)<2.0 times the upper limit of normal at hospital
9)Total bilirubin<3.0mg/dL
10)Creatinine<1.3mg/dL
11)Patients whose prognosis will be over 3 months
12)Patients who fully understand the study procedures and have given voluntary written informed consent after a full explanation is given
Key exclusion criteria
1)Patients with ileus
2)Patients with no residual intestinal function
3)Patients with severe liver disorder or renal disorder
4)Patients with abnormal glucose metabolism such as severe diabetes mellitus : HbA1c > 7.0%
5)Patients with congenital disorders of amino acid metabolism
6)Patients with allergy to any ingredient of milk
7)Patients with electrolyte metabolism
8)Patients with hemophilia
9)Patients who were given a blood transfusion within 1 month
10)Pregnant women, women suspected of being pregnant, or lactating women
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kunitoshi Yoshino |
Organization
Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name
Department of Otolaryngology, Head and Neck Surgery
Zip code
Address
3-3, Nakamichi 1-chome, Higashinari-ku, Osaka 537-8511, Japan
TEL
06-6972-1181
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hirokazu Uemura, Susumu Nakahara |
Organization
Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name
Department of Otolaryngology, Head and Neck Surgery
Zip code
Address
3-3, Nakamichi 1-chome, Higashinari-ku, Osaka 537-8511, Japan
TEL
06-6972-1181
Homepage URL
Sponsor or person
Institute
Osaka Medical Center for Cancer and Cardiovascular Diseases
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
大阪府立成人病センター（大阪府）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 12 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2010 | Year | 10 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2015 | Year | 05 | Month | 01 | Day |
Date analysis concluded
| 2015 | Year | 06 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 12 | Month | 16 | Day |
Last modified on
| 2016 | Year | 02 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005469
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