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

JRCT ID: jRCTs061190040

Registered date:16/03/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Head and Neck cancer
• Date of first enrollment: 19/11/2020
• Target sample size: 30
• Study type: Interventional
• Intervention(s): Treatment with dietary glucosylceramide

Outcome(s)

• Primary Outcome: degree of the adverse event for the radiation field

Secondary Outcome

Pain, degree, onset, and course of the adverse skin event
Amount of the sphingolipids at the skin
Evaluation of the skin function about transpiration rate, amount of moisture, and range of erythema and macule
Adverse event, side effect

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Fujiwara Kazunori
• Source(s) of Monetary Support: Daicel Corporation