UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008143 |
|---|---|
| Receipt number | 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 12:51:20 |
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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
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
h-urushima@cam.med.osaka-u.ac.jp
Sponsor or person
Institute
Department of Complementary & Alternative Medicine, Graduate school of Medicine, Osaka University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009545
