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Randomized placebo controlled Phase III trial to evaluate the reduction effects of functional foods (AHCC) on the adverse effects of digestive tract cancer chemotherapies and the investigation of the measurement method of cacogeusia

Randomized placebo controlled Phase III trial to evaluate the reduction effects of functional foods (AHCC) on the adverse effects of digestive tract cancer chemotherapies and the investigation of the measurement method of cacogeusia - Phase III study of functional foods (AHCC) for reduction of adverse effects of digestive tract cancer chemotherapies.

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000026461
Enrollment
240
Registered
2017-03-08
Start date
2014-10-31
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

digestive tract cancer

Interventions

Functional food (AHCC): fixed dose Non of Functional food (AHCC)

Sponsors

Kansai Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Digestive tract cancer patients treated with various chemotherapies 2)Aged 20 to 80 years old 3)Patients with no AHCC use history until start of this trial 4)Sufficient oral intake 5)Adequate organ functions 6)ECOG PS of 0 or 1 7)Written informed consent

Exclusion criteria

Exclusion criteria: 1) Continuous use of other functional foods 2) Serious complicating disorders (hepatic cirrhosis, insulin administration-diabetes, cardiac disease, interstitial lung disease, kidney disease, DIC, anemia) 3) Immunodeficiency, immunedepression 4) Pregnant or nursing women 5) Past medical history of drug allergies 6) Active infectious disease 7) Past medical history of alcoholic intoxications and mental disorders 8) Inappropriate for this study judged by the attending physician 9) Under 20 years old and the adults with no capacity of judgment

Design outcomes

Primary

MeasureTime frame
Evaluation for adverse effects and taste disturbance of chemotherapy

Countries

Japan

Contacts

Public ContactSatoshi Hirooka

Kansai Medical University Surgery Division

tomot1226@yahoo.co.jp072-804-0101

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026