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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027222
Receipt No. R000031190
Scientific Title Efficacy of orally administered LEM extract on host QOL and side effect in colorectal cancer patients treated with adjuvant chemotherapy (XELOX).
Date of disclosure of the study information 2017/05/02
Last modified on 2017/05/02

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Basic information
Public title Efficacy of orally administered LEM extract on host QOL and side effect in colorectal cancer patients treated with adjuvant chemotherapy (XELOX).
Acronym LEMOX-Study
Scientific Title Efficacy of orally administered LEM extract on host QOL and side effect in colorectal cancer patients treated with adjuvant chemotherapy (XELOX).
Scientific Title:Acronym LEMOX-Study
Region
Japan

Condition
Condition High-risk stage II/ III colorectal cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of Lentinula edodes mycelia (LEM) extract on host QOL in colorectal cancer patients treated with adjuvant chemotherapy (XELOX)
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Improvement of QOL with LEM in patients undergoing adjuvant chemotherapy
Key secondary outcomes completion rate of 8-cycle oxaliplatin and oxaliplatin-related side effect

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Orally administered LEM of 1,800mg/day for 6 months during adjuvant chemotherapy (XELOX)
Interventions/Control_2 Orally administered placebo for 6 months during adjuvant chemotherapy (XELOX)
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 Male and Female
Key inclusion criteria 1)High-risk Stage II/ Stage III colorectal cancer patients suitable for adjuvant XELOX chemotherapy
2)Performance status of 0, 1 or 2, to be older than 20 years of age
3)Adequate bone marrow (white blood cell count >3,000 mm3, hemoglobin >10 g/dl and platelet count > 75,000/mm3), renal function (serum creatinine <1.4 mg/dl) and liver function (bilirubin <1.5 mg/dl and transaminase wiyhin 2.5 times the institution's upper limit of normal) were required
4)Complete written informed consent was obtained from the patients at the time of enrollment.
Key exclusion criteria 1)Patient having multiple cancer
2)Patient having or suspicious for severe infectious disease
3)Patient having uncontrollable heart disease, pulmonary disease or hepatic disease
4) Patient who is not appropriate for entry judged by the chief investigator
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kiyotaka, OKUNO
Organization Faculty of Medicine, Kindai University
Division name Deaprtment of Surgery
Zip code
Address 377-2 Ohno-higashi, Osaka-sayama, Osaka
TEL 072-366-0221
Email okuno@surg.med.kindai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kiyotaka, OKUNO
Organization Faculty of Medicine, Kindai University
Division name Deaprtment of Surgery
Zip code
Address 377-2 Ohno-higashi, Osaka-sayama, Osaka
TEL 072-366-0221
Homepage URL
Email okuno@surg.med.kindai.ac.jp

Sponsor
Institute Department of Surgery, Faculty of Medicine, Kindai University
Institute
Department

Funding Source
Organization Kindai University
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
Email

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
2017 Year 05 Month 02 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
LEM administration did not contribute to improve the QOL of the patients treated with adjuvant chemotherapy. However, the grade 2 neurpathy due to oxaliplatin might be decreased by the LEM administration.
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 Completed
Date of protocol fixation
2013 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 05 Month 01 Day
Last follow-up date
2016 Year 08 Month 25 Day
Date of closure to data entry
2016 Year 08 Month 25 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 05 Month 02 Day
Last modified on
2017 Year 05 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031190

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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