Unique ID issued by UMIN | UMIN000010047 |
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Receipt number | R000011765 |
Scientific Title | Evaluation of host QOL and immune function in breast cancer patients with combination of adjuvant chemotherapy and oral administration of Lentinula edodes mycelia extract. |
Date of disclosure of the study information | 2013/02/14 |
Last modified on | 2013/09/09 12:56:31 |
Evaluation of host QOL and immune function in breast cancer patients with combination of adjuvant chemotherapy and oral administration of Lentinula edodes mycelia extract.
Evaluation of host QOL and immune function in breast cancer patients with combination of adjuvant chemotherapy and oral administration of Lentinula edodes mycelia extract.
Evaluation of host QOL and immune function in breast cancer patients with combination of adjuvant chemotherapy and oral administration of Lentinula edodes mycelia extract.
Evaluation of host QOL and immune function in breast cancer patients with combination of adjuvant chemotherapy and oral administration of Lentinula edodes mycelia extract.
Japan |
breast cancer
Breast surgery |
Malignancy
NO
To evaluate the host QOL and immune function in breast cancer patients with combination of adjuvant chemotherapy and oral administration of Lentinula edodes mycelia extract.
Efficacy
QOL(FACT-BRM)
Interventional
Parallel
Randomized
Open -no one is blinded
Active
2
Treatment
Medicine | Maneuver |
1)Curative resection of breast cancer.
2)Adjuvant chemotherapy with FAC, FEC, AC or EC.
1)Curative resection of breast cancer.
2)Adjuvant chemotherapy with FAC, FEC, AC or EC combined with LEM.
20 | years-old | <= |
Not applicable |
Female
1)Histologically proven breast cancer.
2)4) Adequate organ functions:
WBC >=3500/mm3 and <=12000/mm3,
platelets >=100,000/mm3,
hemoglobin >=8.0g/dL,
total bilirubin <=1.5mg/dL,
AST(GOT)/ALT(GPT) <=2.5 X UL,
creatinine <=UL.
3)ECOG Performance status:0-2.
4)Expected survival over 3 months.
5)Age of 20 years or older.
6)female
7)Written informed consent
1)Pregnant females, possibly pregnant
females, females wishing to become pregnant.
2)Nursing mothers.
3)Prior radiotherapy, chemotherapy or hormone therapy.
4)Other patients who are unfit for the study as determined by the attending physician.
40
1st name | |
Middle name | |
Last name | Masaaki Oka |
Yamaguchi University Graduate School of Medicine
Department of Digestive Surgery and Surgical Oncology
1-1-1 Minamikokushi, Ube, Yamaguchi 755-8505, Japan
0836-22-2264
sigefumi@yamaguchi-u.ac.jp
1st name | |
Middle name | |
Last name | Shigefumi Yoshino |
Yamaguchi University Graduate School of Medicine
Department of Digestive Surgery and Surgical Oncology
1-1-1 Minamikokushi, Ube, Yamaguchi 755-8505, Japan
0836-22-2264
sigefumi@yamaguchi-u.ac.jp
Department of Digestive Surgery and Surgical Oncology, Yamaguchi University Graduate School of Medicine
Department of Digestive Surgery and Surgical Oncology, Yamaguchi University Graduate School of Medicine
Other
NO
2013 | Year | 02 | Month | 14 | Day |
Unpublished
Open public recruiting
2010 | Year | 10 | Month | 21 | Day |
2011 | Year | 01 | Month | 01 | Day |
2013 | Year | 02 | Month | 14 | Day |
2013 | Year | 09 | Month | 09 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011765
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