Inhibitory effects of glucosylceramide

JRCT ID: jRCTs061180061

Registered date:18/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Head and neck squamous cell carcinoma
• Date of first enrollment: 07/07/2015
• Target sample size: 30
• Study type: Interventional
• Intervention(s): Treatment of dietary glucosylceramide

Outcome(s)

• Primary Outcome: Disease free survival (DFS)

Secondary Outcome

Relapse-free survival (RFS)
Overall survival
Adverse event
Side reaction

Key inclusion & exclusion criteria

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

Include criteria

1)Histological type is squamous cell carcinoma
2)Primary site is paranasal sinus, oral cavity, oropharynx, hypopharynx, larynx.
3)Stage3 or stage4A,4B, which had surgery, radiation and chemoradiation.
4)Cases identified as complete response by histological examination and imaging test.
5)20 years of age and older.
6)Ability of oral intake
7)Performance status (PS) 0-1
8)No abnormalities of Bone marrow function, renal function, and liver function within the first 14 days.
9)Informed concent is obtained.

Exclude criteria

1)Cases with allergic symptom by konnyaku.
2)Cases with infection disease requiring treatment
3)Cases with gastrointestinal disease requiring treatment
4)Cased with interstitial pneumonia and lung fibrosis.
5)Cases with poorly controlled diabetes.
6)Cases with severe liver damage.
7)Cases with severe diarrhea.
8)Pregnant woman or potential.
9)Cases deemed inappropriate by principal investigator.

Related Information

• Primary Sponsor: Fujiwara Kazunori
• Secondary ID(s): UMIN000035146