UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031386 |
|---|---|
| Receipt number | 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 15:29:31 |
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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
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
reo-h@nifty.com
Sponsor or person
Institute
Non-Profit Organization JORTC
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035839
