UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009426 |
|---|---|
| Receipt number | R000011074 |
| Scientific Title | Examination for severe pruritus in head and neck cancer patients and development for effective treatment. |
| Date of disclosure of the study information | 2012/12/04 |
| Last modified on | 2013/03/21 22:44:47 |
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Basic information
Public title
Examination for severe pruritus in head and neck cancer patients and development for effective treatment.
Acronym
Examination for severe pruritus in head and neck cancer patients and development for effective treatment.
Scientific Title
Examination for severe pruritus in head and neck cancer patients and development for effective treatment.
Scientific Title:Acronym
Examination for severe pruritus in head and neck cancer patients and development for effective treatment.
Region
| Japan |
Condition
Condition
Head and neck cancer
Classification by specialty
| Dermatology | Oto-rhino-laryngology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the reason of pruritus in head and neck cancer patient who receive chemo-radiation therapy and evaluate the treatment and its efficacy. Especially, to investigate efficacy of ceramide cream for skin protection and moisturizer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Moisturizing effect
Anti itch effect
Duratation of the effect
Days in hospital
Adverse event i.e. pain
Key secondary outcomes
Use of antiallergic agent
Completion rate of chemo-radiation therapy
Effect of cancer therapy
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are 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
ceramide cream
Interventions/Control_2
Hildoid lotion
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
1.Patient age 20 years and above
2.Head and neck cancer after common therapy
3.Patients who have pruritus which does not disappear by existing treatment
4.Patients who were provided written informed consent
Key exclusion criteria
1.Possibility of the remarkabke phisical damage by this treatment
2.Patient judged by the investigator to be unfit to be enrolled into the study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Junkichi Yokoyama |
Organization
Juntendo university school of medicine
Division name
Department of Otolaryngology, head and neck surgery
Zip code
Address
3-1-1, Hongo, Bunkyou-ku, Tokyo
TEL
03-3813-3111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Junkichi Yokoyama |
Organization
Juntendo university school of medicine
Division name
Department of Otolaryngology, head and neck surgery
Zip code
Address
TEL
Homepage URL
gakujutu@juntendo.ac.jp
Sponsor or person
Institute
Juntendo university school of medicine
Institute
Department
Personal name
Funding Source
Organization
Research institute of environmental medicine
Organization
Division
Category of Funding Organization
Other
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 | 12 | Month | 04 | 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
| 2012 | Year | 11 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 12 | Month | 04 | 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 | 28 | Day |
Last modified on
| 2013 | Year | 03 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011074
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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