UMIN-CTR Clinical Trial

Public title

Evaluation of Lentinula edodes mycelia for QOL, side effects and host immunity in breast cancer patients treated with chemotherapy

Acronym

Evaluation of Lentinula edodes mycelia for QOL, side effects and host immunity in breast cancer patients treated with chemotherapy

Scientific Title

Evaluation of Lentinula edodes mycelia for QOL, side effects and host immunity in breast cancer patients treated with chemotherapy

Scientific Title:Acronym

Evaluation of Lentinula edodes mycelia for QOL, side effects and host immunity in breast cancer patients treated with chemotherapy

Region

Japan

Condition

breast cancer

Classification by specialty

Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

Evaluation of Lentinula edodes mycelia for QOL, side effects and host
immunity in breast cancer patients treated with chemotherapy

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

QOL

Key secondary outcomes

immuno parameter
adverse event

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is considered as a block.

Blocking

YES

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Lentinula edodes mycelia

Interventions/Control_2

placebo

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Female

Key inclusion criteria

1.Patients with histologically confirmed breast cancer
2.Patients who are scheduled to initiate treatment with a drip infusion every 3 week cycle (FEC, EC, AC, CAF) among chemotherapy including anthracycline antitumor drugs
3.Patients with sufficient function of main organs to undergo chemotherapy
4.Patient with a performance status (ECOG scale) of 0 - 1
5.Patients with life expectancy of at least 3 month from the date of enrollment
6.Patients who are aged 20 years or older at the time of obtaining informed consent
7.Female patients
8.Patients who are able to maintain sufficient oral intake
9.Patients who are able to submit written informed consent for participation in this study

Key exclusion criteria

1.Patients who are pregnant or may be pregnant
2.Patients who are nursing
3.Patients who received previous treatments other than surgery (such as radiation therapy, chemotherapy and hormone therapy) in the last 4 weeks after study enrollment.
4.Patients who started taking the following new healthy foods in the past 2 weeks after enrollment in this study.
Agaricus, Tturmeric, Shark cartilage, Propolis, Bracket fungus, Coenzyme Q10, Aojiru (Green juice), Chlorella, Phellinus linteus, Fucoidan, Royal jelly, DHA, Aloe, PC-SPEC, Saw palmetto, Ganoderma lucidum, Selenium, b-carotene, Isoflavone, Garlic, Black vinegar, Ginkgo leaf extract, Lactobacillus preparation, etc.
5.Patients who are considered ineligible for participation in this study based on decision of a responsible investigator

Target sample size

40

Name of lead principal investigator

1st name
Middle name
Last name	Oka Masaaki

Organization

Yamaguchi University Hospital

Division name

Department of Digestive Surgery and Surgical Oncology

Zip code

Address

1-1-1 MINAMIKOGUSHI, UBE, YAMAGUCHI

TEL

0836-22-2264

Email

Name of contact person

1st name
Middle name
Last name

Organization

Japan Society for Cancer Chemotherapy

Division name

Clinicaltest Control Staff

Zip code

Address

TEL

06-6447-7106

Homepage URL

Email

Institute

Japan Society for Cancer Chemotherapy

Institute

Department

Personal name

Organization

Osaka, Cancer. Research Foundation

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2010

Year

12

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2010

Year

11

Month

08

Day

Date of IRB

Anticipated trial start date

2011

Year

01

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2010

Year

11

Month

24

Day

Last modified on

2016

Year

08

Month

10

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005444