臨床研究等提出・公開システム

Japanese

Date of registration	Mar. 18, 2019
Last modified on	Mar. 29, 2023
Trial ID	jRCTs031180324

Scientific Title	Efficacy of Oral AHCC Supplementation in Female Breast Cancer Patients undergoing Anthracycline or Taxan-based Anticancer Drug: Randomized, Double-blind, Placebo controlled Confirmatory study
Public Title	Efficacy of AHCC in Breast Cancer Patients undergoing Anthracycline or Taxan-based Anticancer Drug

Contact for Scientific Queries	Name	Hamaguchi Reo
	Affiliation	Nagumo Clinic Tokyo
	Address	3-10 Sanbancho, Chiyoda-ku, Tokyo
	Telephone	+81-3-6261-3251
	E-mail	reo-h@nifty.com
Contact for Public Queries	Name	Hamaguchi Reo
	Affiliation	Nagumo Clinic Tokyo
	Address	3-10 Sanbancho, Chiyoda-ku, Tokyo
	Telephone	+81-3-6261-3251
	E-mail	reo-h@nifty.com

Recruitment status	Recruiting

Anticipated date of first enrollment		April. 01, 2018
Actual date of first enrollment		April. 02, 2018
Target sample size		60
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	placebo control
	assignment	parallel assignment
	purpose	prevention purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Agree to undergo adjuvant chemotherapy and plan to receive Doxorubicin/Cyclophosphamide (AC), Epirubicin/Cyclophosphamide (EC), 5-Fluorouracil/Epirubicin/Cyclophosphamide (FEC), Paclitaxel (PTX), nab-Paclitaxel (nab-PTX), Docetaxel (DTX), or Docetaxel/Cyclophosphamide (TC) therapy
	Exclusion Criteria	Currently taking dietary supplements derived from basidiomycetes (such as agaricus or health food derived from a mushroom) (allowed if discontinued for more than 7 days before the start of the study) Currently taking dietary supplements except for multivitamins (allowed if discontinued for more than 7 days before the start of the study) Allergy for a health food derived from a mushroom or basidiomycetes
	Age Minimum	20age old over
	Age Maximum	70age old not
	Gender	Female
Health Condition(s) or Problem(s) Studied		Breast Neoplasms
Intervention(s)		Oral AHCC Supplementation
Health Condition(s) Keyword		Breast cancer, breast neoplasms
Intervention(s) Keyword		AHCC
Health Condition(s) Code		D001943
Intervention(s) Code		C499366
Primary Outcome(s)		The total number of doses of the G-CSF per the total number of completed course of the chemotherapy
Secondary Outcome(s)		The total number of doses of the G-CSF for each course number of the chemotherapy The number of doses of the G-CSF in each course of the chemotherapy Incidence rate of febrile neutropenia Incidence rates of adverse events according to CTCAE v.4.0-JCOG of grade 1 or higher, grade 2 or higher EORTC QLQ-C30 and EORTC QLQ-BR23 scores Adherence to protocol (AHCC/placebo) Completion rate of 4 courses of chemotherapy and the proportion of completion without delay or dose reduction Efficacy assessment of neoadjuvant chemotherapy or metastatic/recurrent cases based on RECIST v1.1

Primary Sponsor

Source of Monetary Support / Secondary Sponsor	JORTC (Japanese Organisation for Research and Treatment of Cancer)
Secondary Sponsor	Applicable

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Clinical Research Review Board of Saitama Medical University
Address	38, Morohongo, Irumagun Moroyamamachi, Saitama-Pref, 350-0495, Japan, Saitama
Telephone	+81-49-276-1662
E-Mail	tokutei@saitama-med.ac.jp
Approval Status	Approval
Date of approval	Mar. 07, 2019

Plan to share IPD	No
Plan description

Secondary ID(s)	UMIN000031386
Issuing Authority	UMIN-CTR

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
6	Mar. 29, 2023	(this page)	Changes
5	Sept. 13, 2021	Detail	Changes
4	Aug. 12, 2020	Detail	Changes
3	Feb. 10, 2020	Detail	Changes
2	July. 03, 2019	Detail	Changes
1	Mar. 18, 2019	Detail

List of change history