UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015455
Receipt number R000017961
Scientific Title Efficacy of Oral AHCC Supplementation in Female Breast Cancer Patients undergoing Anthracycline and Taxane based Adjuvant chemotherapy: Randomized, Double-blind, Placebo controlled, Phase-II Study
Date of disclosure of the study information 2014/10/20
Last modified on 2017/04/20 13:17:58

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Basic information

Public title

Efficacy of Oral AHCC Supplementation in Female Breast Cancer Patients undergoing Anthracycline and Taxane based Adjuvant chemotherapy: Randomized, Double-blind, Placebo controlled, Phase-II Study

Acronym

Efficacy of AHCC in Female Breast Cancer Patients undergoing Adjuvant chemotherapy:
Randomized, Double-blind, Placebo controlled, Phase-II Study

Scientific Title

Efficacy of Oral AHCC Supplementation in Female Breast Cancer Patients undergoing Anthracycline and Taxane based Adjuvant chemotherapy: Randomized, Double-blind, Placebo controlled, Phase-II Study

Scientific Title:Acronym

Efficacy of AHCC in Female Breast Cancer Patients undergoing Adjuvant chemotherapy:
Randomized, Double-blind, Placebo controlled, Phase-II Study

Region

Japan


Condition

Condition

Patients receiving adjuvant chemotherapy for breast cancer

Classification by specialty

Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy of AHCC in female breast cancer patients undergoing anthracycline and taxane based adjuvant chemotherapy.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Frequency of grade 2 or higher adverse events by CTCAE v4.0 in WBC, neutrophil, Hb, Plt, T-Bil, ALP, AST, ALT, gamma-GTP, TG, Cre

Key secondary outcomes



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

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

AHCC (1.0g) is orally administered after each meal from day 1 of Taxan therapy for 12 weeks

Interventions/Control_2

Placebo (1.0g) is orally administered after each meal from day 1 of Taxan therapy for 12 weeks

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

65 years-old >

Gender

Female

Key inclusion criteria

1. Able to give written informed consent
2. Female above age 20 and below 65
3. Histologically confirmed diagnosis of breast cancer
4. Received or receiving anthracycline based treatment(AC, EC or 5FU, FEC) and Scheduled to receive any taxane based chemotherapy for 12 weeks
5. EGOC performance status 0 or 1
6. Adequate organ and marrow function measured within 14 days of enrollment;
WBC>=3,000 /mm3
Hemoglobin>=10 g/dL
ALP=<805 U/L
Gamma-GTP=<80 U/L
TG=<300mg/dL
Neutrophil>=1,500/ mm3
Thrombocyte>=75000/mm3
Total bilirubin=<2.25mg/dL
AST=<90 U/L
ALT=<69 U/L
Serum creatinine=<1.185 mg/dL

Key exclusion criteria

1. Previous chemotherapy which induce bone marrow suppression
2. Concurrent radiation or radiation within the past 4 weeks
3. Use of any mushroom based dietary supplement (7 day washout allowed)
4. Use of any other mixed herbal formula (nutritional multi vitamins are allowed)
5. Known allergy to any mushroom supplement or edible mushroom
6. Pregnant or lactating
7. Immunodeficiency disorder
8. Enrolled in other clinical trial
9. Cognitive impairment
10. Mental disorder
11. Communication difficulties due to anarthria
12. Inability to take oral medication
13. Malabsorption syndrome
14. Prior gastric resection
15. Active GI bleeding unrelated to cancer
16. The investigator's decision that a patient is inappropriate to enroll in the trial

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Sho Hangai

Organization

The University of Tokyo

Division name

Dept. of Molecular Immunology, Institute of Industrial Science

Zip code


Address

4-6-1, Komaba, Meguro-ku Tokyo, 153-8505 Japan

TEL

03-5452-6491

Email

hangai-tky@umin.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Keisuke Ariyoshi

Organization

NPO JORTC

Division name

JORTC Data Center

Zip code


Address

2-54-6-302, Nishinippori, Arakawa-ku, Tokyo 116-0013, JAPAN

TEL

03-5604-9850

Homepage URL


Email

keisuke.ariyoshi@jortc.jp


Sponsor or person

Institute

NPO Japanese Organisation for Research and Treatment of Cancer (JORTC)

Institute

Department

Personal name



Funding Source

Organization

Amino Up Chemical 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

2014 Year 10 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

Terminated

Date of protocol fixation

2014 Year 08 Month 14 Day

Date of IRB


Anticipated trial start date

2014 Year 11 Month 01 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

2014 Year 10 Month 17 Day

Last modified on

2017 Year 04 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017961


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name