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The efficacy testing of a Glu-Cer against adverse skin event

Phase 2
Conditions
Head and Neck cancer
Registration Number
JPRN-jRCTs061190040
Lead Sponsor
Fujiwara Kazunori
Brief Summary

It is possible that oral administration of ceramide improves the moisturizing function, and if a moisturizing effect is obtained, it may be expected to suppress the onset of skin disorders. On the other hand, hifu002 did not improve the moisturizing effect despite oral administration. Although we do not know why the moisturizing effect was not improved, the development of severe skin damage suggest that there may be some relationship between the moisturizing effect and the degree of skin damage.

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
7
Inclusion Criteria

Origin of the cancer: maxillary, oral cavity, pharynx, larynx, cervical esophagus
Recieve chemoradiation against head and neck cancer
Over 20 years old
Enable to take a medicine orally
Patient with bone marrow, and/or hepatic, and/or renal insufficiency within 14 days before starting of a trial
Sign a consent form on one's own

Exclusion Criteria

Konjac allergy
Prominent symptom at the site of a skin test
Patient who had chronic skin disorder like collagen diseases and take medication regularly
Remain under other scrutiny, or within 3 months after finishing other clinical trial
Asthma patients
Take antihistamine medicine
At risk of becoming pregnant and breast-feeding woman

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
degree of the adverse event for the radiation field
Secondary Outcome Measures
NameTimeMethod
Pain, degree, onset, and course of the adverse skin event<br>Amount of the sphingolipids at the skin<br>Evaluation of the skin function about transpiration rate, amount of moisture, and range of erythema and macule<br>Adverse event, side effect
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