Unique ID issued by UMIN | UMIN000015455 |
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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 |
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
Efficacy of AHCC in Female Breast Cancer Patients undergoing Adjuvant chemotherapy:
Randomized, Double-blind, Placebo controlled, Phase-II Study
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
Efficacy of AHCC in Female Breast Cancer Patients undergoing Adjuvant chemotherapy:
Randomized, Double-blind, Placebo controlled, Phase-II Study
Japan |
Patients receiving adjuvant chemotherapy for breast cancer
Breast surgery |
Malignancy
NO
To evaluate the efficacy of AHCC in female breast cancer patients undergoing anthracycline and taxane based adjuvant chemotherapy.
Safety,Efficacy
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
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
YES
Institution is considered as adjustment factor in dynamic allocation.
NO
Central registration
2
Prevention
Food |
AHCC (1.0g) is orally administered after each meal from day 1 of Taxan therapy for 12 weeks
Placebo (1.0g) is orally administered after each meal from day 1 of Taxan therapy for 12 weeks
20 | years-old | <= |
65 | years-old | > |
Female
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
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
50
1st name | |
Middle name | |
Last name | Sho Hangai |
The University of Tokyo
Dept. of Molecular Immunology, Institute of Industrial Science
4-6-1, Komaba, Meguro-ku Tokyo, 153-8505 Japan
03-5452-6491
hangai-tky@umin.ac.jp
1st name | |
Middle name | |
Last name | Keisuke Ariyoshi |
NPO JORTC
JORTC Data Center
2-54-6-302, Nishinippori, Arakawa-ku, Tokyo 116-0013, JAPAN
03-5604-9850
keisuke.ariyoshi@jortc.jp
NPO Japanese Organisation for Research and Treatment of Cancer (JORTC)
Amino Up Chemical Co.,Ltd.
Profit organization
NO
2014 | Year | 10 | Month | 20 | Day |
Unpublished
Terminated
2014 | Year | 08 | Month | 14 | Day |
2014 | Year | 11 | Month | 01 | Day |
2014 | Year | 10 | Month | 17 | Day |
2017 | Year | 04 | Month | 20 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017961
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