RCT With Adjuvant Mistletoe Treatment in Gastric Cancer Patients
NCT ID: NCT01401075
Last Updated: 2012-11-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
32 participants
INTERVENTIONAL
2006-03-31
2008-04-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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doxifluridine
oral chemotherapy with the 5-FU prodrug doxifluridine
doxifluridine
600 - 900 mg per day orally, depending on weight and status of the patient
doxifluridine + mistletoe extract
oral chemotherapy with the 5-FU prodrug doxifluridine + mistletoe extract as subcutaneous injection
mistletoe extract
subcutaneous injections thrice weekly with 1 ml in 4 increasing doses
doxifluridine
600 - 900 mg per day orally, depending on weight and status of the patient
Interventions
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mistletoe extract
subcutaneous injections thrice weekly with 1 ml in 4 increasing doses
doxifluridine
600 - 900 mg per day orally, depending on weight and status of the patient
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* indication for oral chemotherapy with doxifluridine
* ECOG performance status 0 or 1
* normal liver and kidney function
Exclusion Criteria
* concomitant therapy with steroids or biological response modifiers
* individual hypersensitivity to mistletoe preparations
* pregnancy or lactating
* participation in another clinical trial
19 Years
70 Years
ALL
No
Sponsors
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Abnoba Gmbh
INDUSTRY
Responsible Party
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Principal Investigators
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Byung-Sik Kim, Professor
Role: PRINCIPAL_INVESTIGATOR
ASAN Medical Center, Seoul
Locations
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ASAN Medical Center
Seoul, , South Korea
Countries
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References
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Kim KC, Yook JH, Eisenbraun J, Kim BS, Huber R. Quality of life, immunomodulation and safety of adjuvant mistletoe treatment in patients with gastric carcinoma - a randomized, controlled pilot study. BMC Complement Altern Med. 2012 Oct 3;12:172. doi: 10.1186/1472-6882-12-172.
Other Identifiers
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AB-AVQ20-1.0
Identifier Type: -
Identifier Source: org_study_id