RCT With Adjuvant Mistletoe Treatment in Gastric Cancer Patients

NCT ID: NCT01401075

Last Updated: 2012-11-07

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2008-04-30

Brief Summary

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Evaluation of safety and efficacy of a standardized mistletoe extract (abnobaVISCUM® Quercus, aVQ) in patients with gastric cancer receiving oral chemotherapy.

Detailed Description

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Conditions

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Gastric Cancer

Keywords

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Quality of Life QoL EORTC QLQ-C30 EORTC QLQ-STO22 5-FU Viscum album

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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doxifluridine

oral chemotherapy with the 5-FU prodrug doxifluridine

Group Type ACTIVE_COMPARATOR

doxifluridine

Intervention Type DRUG

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

Group Type EXPERIMENTAL

mistletoe extract

Intervention Type DRUG

subcutaneous injections thrice weekly with 1 ml in 4 increasing doses

doxifluridine

Intervention Type DRUG

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

Intervention Type DRUG

doxifluridine

600 - 900 mg per day orally, depending on weight and status of the patient

Intervention Type DRUG

Other Intervention Names

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abnobaVISCUM Quercus 0.02 mg abnobaVISCUM Quercus 0.2 mg abnobaVISCUM Quercus 2 mg abnobaVISCUM Quercus 20 mg Didox

Eligibility Criteria

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Inclusion Criteria

* postoperative UICC stage Ib/II gastric carcinoma
* indication for oral chemotherapy with doxifluridine
* ECOG performance status 0 or 1
* normal liver and kidney function

Exclusion Criteria

* inability to answer the QoL scales
* concomitant therapy with steroids or biological response modifiers
* individual hypersensitivity to mistletoe preparations
* pregnancy or lactating
* participation in another clinical trial
Minimum Eligible Age

19 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abnoba Gmbh

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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South Korea

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.

Reference Type RESULT
PMID: 23033982 (View on PubMed)

Other Identifiers

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AB-AVQ20-1.0

Identifier Type: -

Identifier Source: org_study_id