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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000008143
Receipt No. R000009545
Scientific Title Randomized, placebo-controlled trial of AHCC for the reduction of side effects in breast cancer chemotherapy
Date of disclosure of the study information 2012/06/12
Last modified on 2013/12/16

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Basic information
Public title Randomized, placebo-controlled trial of AHCC for the reduction of side effects in breast cancer chemotherapy
Acronym RCT of AHCC for the reduction of side effects in breast cancer chemotherapy
Scientific Title Randomized, placebo-controlled trial of AHCC for the reduction of side effects in breast cancer chemotherapy
Scientific Title:Acronym RCT of AHCC for the reduction of side effects in breast cancer chemotherapy
Region
Japan

Condition
Condition breast cancer
Classification by specialty
Endocrine surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The chemotherapy is placed as one of the multidisciplinary cancer therapies. However, chemotherapy is often weakened or is discontinued because of the adverse events such as bone marrow suppression and gastrointestinal disturbance. We previously examined the safety and the effectiveness of AHCC during chemotherapy. The results suggested that the number of white blood cells, especially neutrophils, significantly decreased by using AHCC. The RCT of AHCC has not examined so far. We are now planning to use AHCC in the adjuvant chemotherapy "FEC 75 (5-FU+Epirubicin+cyslophosphamide)" for breast cancer patients, and to examine for the effectiveness with RCT.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The primary endpoint is to reduce adverse events during chemotherapy reffered CTCAE ver 4.0.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 control group
placebo 10tablets/day
start before 1week of FEC75 and continue 12weeks.
Interventions/Control_2 AHCC group
AHCC 10tablets/day
start before 1week of FEC75 and continue 12weeks.
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

Not applicable
Gender Female
Key inclusion criteria Diagnosed as breast cancer and treated neo-adjuvant chemotherapy "FEC75"

Hemoglobin:>10.0 g/dl
WBC:>3,000/mm3 and <12,000/mm3
Platelets:>100,000/mm3
AST and ALT less than 2.5 times than our standard.
Serum bilirubin:>1.5 mg/dl
Serum creatinin:>2.0 mg/dl
Key exclusion criteria 1)The case who will take in functional food shown as below during FEC75
AgaricusTturmeric,Shark cartilage, Tahibo,Propolis,Shelf fungus,Coenzyme Q10,Vegetable juice,Chlorella,Fomes yucatensis,Fucoidan,Royal jelly,DHA, Aloe,PC-SPES,Saw palmetto,Bracket fungus,Selenium,Beta carotene,Isoflavone,Garlic,Black vinegar,Ginkgo biloba extract,Lactic-acid-bacteria tablet
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshinori Ito
Organization Graduate school of Medicine, Osaka University
Division name Department of Alternative & Complementary Medicine
Zip code
Address 2-2 Yamadaoka Suita Osaka
TEL 06-6879-3498
Email h-urushima@cam.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hayato Urushima
Organization Graduate school of Medicine, Osaka University
Division name Department of Alternative & Complementary Medicine
Zip code
Address 2-2,Yamadaoka,Suita,Osaka,Japan
TEL 06-6879-3498
Homepage URL
Email h-urushima@cam.med.osaka-u.ac.jp

Sponsor
Institute Department of Complementary & Alternative Medicine, Graduate school of Medicine, Osaka University
Institute
Department

Funding Source
Organization No Funding Source
Organization
Division
Category of Funding Organization Other
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
2012 Year 06 Month 12 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
2012 Year 05 Month 02 Day
Date of IRB
Anticipated trial start date
2012 Year 06 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
2012 Year 06 Month 12 Day
Last modified on
2013 Year 12 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009545

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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