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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031386
Receipt No. R000035839
Scientific Title Efficacy of Oral AHCC Supplementation in Female Breast Cancer Patients Undergoing Anthracycline-based Anticancer Drug as Adjuvant Chemotherapy: Randomized, Double-blind, Placebo controlled, Confirmatory Study
Date of disclosure of the study information 2018/02/20
Last modified on 2019/02/21

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Basic information
Public title Efficacy of Oral AHCC Supplementation in Female Breast Cancer Patients Undergoing Anthracycline-based Anticancer Drug as Adjuvant Chemotherapy: Randomized, Double-blind, Placebo controlled, Confirmatory Study
Acronym Efficacy of AHCC in Breast Cancer Patients Undergoing Anthracycline-based Adjuvant Chemotherapy: Placebo controlled, Confirmatory Study
Scientific Title Efficacy of Oral AHCC Supplementation in Female Breast Cancer Patients Undergoing Anthracycline-based Anticancer Drug as Adjuvant Chemotherapy: Randomized, Double-blind, Placebo controlled, Confirmatory Study
Scientific Title:Acronym Efficacy of AHCC in Breast Cancer Patients Undergoing Anthracycline-based Adjuvant Chemotherapy: Placebo controlled, Confirmatory Study
Region
Japan

Condition
Condition Breast cancer
Classification by specialty
Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the efficacy of AHCC in female breast cancer patients undergoing anthracycline-based adjuvant chemotherapy (AC; Doxorubicin/Cyclophosphamide, EC; Epirubicin/Cyclophosphamide, FEC; 5-Fluorouracil/Epirubicin/Cyclophosphamide).
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes The total number of doses of the G-CSF per the total number of completed course of the adjuvant chemotherapy
Key secondary outcomes 1) The total number of doses of the G-CSF for each course number of adjuvant chemotherapy
2) The number of doses of the G-CSF in each course of the adjuvant chemotherapy
3) Incidence rate of febrile neutropenia
4) Incidence rates of adverse events according to CTCAE v.4.0-JCOG of grade 1 or higher, grade 2 or higher
5) EORTC QLQ-C30 and EORTC QLQ-BR23 scores
6) Adherence to protocol (AHCC/placebo)
7) Completion rate of 4 courses of adjuvant chemotherapy and the proportion of completion without delay or dose reduction
8) Effect measurement based on RECIST v1.1 after the neoadjuvant chemotherapy

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 To be taken 2 capsules of AHCC (0.5 g) three times a day after meals (6 capsules in total, 3.0 g/day) from the start of the adjuvant chemotherapy.
Interventions/Control_2 To be taken 2 capsules of placebo (0.5 g) three times a day after meals (6 capsules in total, 3.0 g/day) from the start of the adjuvant chemotherapy.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
70 years-old >
Gender Female
Key inclusion criteria 1. Understanding of the nature and consequences of the study and voluntary signature of the informed consent document
2. Female of age >= 20 and < 70 years at the time of consent
3. Histologically confirmed breast cancer
4. Agree to undergo adjuvant chemotherapy and plan to receive Doxorubicin/Cyclophosphamide (AC), Epirubicin/Cyclophosphamide (EC), or 5-Fluorouracil/Epirubicin/Cyclophosphamide (FEC) therapy
5. Eastern Cooperative Oncology Group Performance Status <= 1
6. Laboratory findings within the following ranges (at <= 14 days prior to enrollment);
(1) Leukocytes >= 3,000/mm3
(2) Neutrophil counts >= 1,500/mm3
(3) Hemoglobin >= 9.0 g/dL
(4) Platelets >= 75,000/mm3
(5) Total bilirubin <= 1.5 mg/dL
(6) Aspartate aminotransferase <= 100 U/L
(7) Alanine aminotransferase <= 100 U/L
(8) Serum creatinine <= 1.5 mg/dL
Key exclusion criteria 1. Previous treatment with chemotherapy
2. Previous treatment with radiation simultaneously with chemotherapy or received <= 4 weeks prior to enrollment
3. 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)
4. Currently taking dietary supplements except for multivitamins (allowed if discontinued for more than 7 days before the start of the study)
5. Allergy for a health food derived from a mushroom or basidiomycetes
6. Pregnant or breastfeeding
7. Immune deficiency
8. Enrollment in other clinical trials
9. Cognitive disorder prior to enrollment
10. Psychiatric disorder that may affect data sampling
11. Unable to communicate verbally
12. Uncapable of oral ingestion
13. Malabsorption syndrome
14. Past history of gastrectomy
15. Active gastrointestinal bleeding unrelated with cancer
16. Investigator considers that the patient is not suitable for the study
Target sample size 42

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Reo Hamaguchi
Organization Nagumo Clinic Tokyo
Division name Department of Breast Surgery
Zip code
Address 3-10 Sanbancho, Chiyoda-ku, Tokyo
TEL 03-6261-3251
Email reo-h@nifty.com

Public contact
Name of contact person
1st name
Middle name
Last name Reo Hamaguchi
Organization Nagumo Clinic Tokyo
Division name Department of Breast Surgery
Zip code
Address 3-10 Sanbancho, Chiyoda-ku, Tokyo
TEL 03-6261-3251
Homepage URL
Email reo-h@nifty.com

Sponsor
Institute Non-Profit Organization JORTC
Institute
Department

Funding Source
Organization AMINO UP Co.,Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2018 Year 02 Month 20 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2017 Year 11 Month 17 Day
Date of IRB
Anticipated trial start date
2018 Year 04 Month 02 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 02 Month 20 Day
Last modified on
2019 Year 02 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035839

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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