UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009348 |
|---|---|
| Receipt number | R000010980 |
| Scientific Title | Evaluation of efficacy of improved nutrition for patients with head and neck cancer underwent oral nutritional supplements. |
| Date of disclosure of the study information | 2012/11/17 |
| Last modified on | 2015/09/11 10:37:46 |
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Basic information
Public title
Evaluation of efficacy of improved nutrition for patients with head and neck cancer underwent oral nutritional supplements.
Acronym
Evaluation of efficacy of improved nutrition for patients with head and neck cancer underwent oral nutritional supplements.
Scientific Title
Evaluation of efficacy of improved nutrition for patients with head and neck cancer underwent oral nutritional supplements.
Scientific Title:Acronym
Evaluation of efficacy of improved nutrition for patients with head and neck cancer underwent oral nutritional supplements.
Region
| Japan |
Condition
Condition
Head and neck cancer
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate a correlation between the dosage of enteral nutrition formula and body weight reduction rate, and effect of nutritional supplement consumption for patients with head and neck cancer. To analyze a relationship between the change rate of each body composition factor and the adverse events as a secondary endpoint.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of change of body weight.
Dose of oral nutritional supplements per body weight.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
RACOL-NF Liquid for Enteral Use
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Patients who will receive any one of the following 3 therapies: chemotherapy, radiation therapy, or chemoradiotherapy.
2.Patients who have been diagnosed and informed of diagnosis with head and neck cancer.
3.Patients who have been judged to be a candidate of oral intake by the investigator.
4.Patients aged 20 years old and older and 75 years old and under.
5.Patients and legal representative who have given voluntary written informed consent.
Key exclusion criteria
1.Patients who have a history of hypersensitivity to enteral nutritional supplements.
2.Patients with ileus.
3.Patients without an enteric function.
4.Patients with severe liver failure and/or renal failure.
5.Patients with abnormal glucose metabolism such as severe diabetes.
6.Patients with inborn error of amino acid metabolism.
7.Patients who had blood transfusion within one month.
8.Patients with active infection.
9.Patients with severe organ failure.
10.Patients who have edema at the time of registration.
11.Patients with electric implantable devices such as pacemakers.
12.Patients who are pregnant, suspected to be pregnant or breastfeeding.
13.Patients judged to be inappropriate for the study by the investigator.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Tsuji |
Organization
Kanazawa Medical University
Division name
Department of Otorhinolaryngology-Head and Neck Surgery
Zip code
Address
1-1 Daigaku Uchinada Kahoku Ishikawa
TEL
076-286-2211
tsujih-i@kanazawa-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kanako Teraguchi |
Organization
Kanazawa Medical University
Division name
Department of Otorhinolaryngology-Head and Neck Surgery
Zip code
Address
1-1 Daigaku Uchinada Kahoku Ishikawa
TEL
076-286-2211
Homepage URL
kanako-y@kanazawa-med.ac.jp
Sponsor or person
Institute
Kanazawa Medical University
Institute
Department
Personal name
Funding Source
Organization
Kanazawa Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 11 | Month | 17 | 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
Completed
Date of protocol fixation
| 2012 | Year | 08 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 11 | Month | 19 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 11 | Month | 17 | Day |
Last modified on
| 2015 | Year | 09 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010980
