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Clinical Trials/JPRN-jRCTs061180061
JPRN-jRCTs061180061CompletedPhase 2

Inhibitory effects of dietary glucosylceramides on head and neck squamous cell carcinoma carcinogenesis and metastasis

Fujiwara Kazunori0 sites6 target enrollmentStarted: March 18, 2019Last updated:
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Conditions

Trial Snapshot

Phase
Phase 2
Status
Completed
Sponsor
Enrollment
6
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
>= 20age old to ot applicable (—)
Sex
All

Inclusion 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.

Exclusion 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.

Investigators

Sponsor
Fujiwara Kazunori

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