RCT With Adjuvant Mistletoe Treatment in Gastric Cancer Patients

November 6, 2012 updated by: Abnoba Gmbh

Prospective Controlled Randomized Comparative Study About Quality of Life (QoL), Immunomodulation and Safety of Adjuvant Mistletoe Treatment in Patients With Gastric Carcinoma Receiving Chemotherapy After Operation

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: doxifluridine
oral chemotherapy with the 5-FU prodrug doxifluridine
Drug: doxifluridine
600 - 900 mg per day orally, depending on weight and status of the patient
Other Names:
  • Didox
Experimental: doxifluridine + mistletoe extract
oral chemotherapy with the 5-FU prodrug doxifluridine + mistletoe extract as subcutaneous injection
Drug: doxifluridine
600 - 900 mg per day orally, depending on weight and status of the patient
Other Names:
  • Didox
Drug: mistletoe extract
subcutaneous injections thrice weekly with 1 ml in 4 increasing doses
Other Names:
  • abnobaVISCUM Quercus 0.02 mg
  • abnobaVISCUM Quercus 0.2 mg
  • abnobaVISCUM Quercus 2 mg
  • abnobaVISCUM Quercus 20 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life
Time Frame: 24 weeks

EORTC Quality of Life Questionnaires:

  1. QLQ-C30
  2. QLQ-STO22
24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immunomodulation
Time Frame: 24 weeks
  1. cytokine levels (TNF-alpha and interleukin-2)
  2. lymphocyte subsets (CD 16+/CD56+ and CD 19+)
24 weeks
Safety and tolerability
Time Frame: 24 weeks
  1. differential blood count
  2. liver functions tests
  3. adverse events
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abnoba Gmbh

Investigators

  • Principal Investigator: Byung-Sik Kim, Professor, ASAN Medical Center, Seoul

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

July 22, 2011

First Submitted That Met QC Criteria

July 22, 2011

First Posted (Estimate)

July 25, 2011

Study Record Updates

Last Update Posted (Estimate)

November 7, 2012

Last Update Submitted That Met QC Criteria

November 6, 2012

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AB-AVQ20-1.0

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

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