Inhibitory effects of glucosylceramide
- Conditions
- Head and neck squamous cell carcinoma
- Registration Number
- JPRN-jRCTs061180061
- Lead Sponsor
- Fujiwara Kazunori
- Brief Summary
Due to the small number of cases, it is not possible to concluded that it has the potential to improve prognosis for head and neck cancer. Since it is an extract from a food, no obvious adverse events are expected.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 6
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Disease free survival (DFS)
- Secondary Outcome Measures
Name Time Method Relapse-free survival (RFS)<br>Overall survival<br>Adverse event<br>Side reaction