RCT With Adjuvant Mistletoe Treatment in Gastric Cancer Patients

This study has been completed.
Information provided by (Responsible Party):
Abnoba Gmbh
ClinicalTrials.gov Identifier:
First received: July 22, 2011
Last updated: November 6, 2012
Last verified: July 2011
Evaluation of safety and efficacy of a standardized mistletoe extract (abnobaVISCUM® Quercus, aVQ) in patients with gastric cancer receiving oral chemotherapy.

Condition Intervention Phase
Gastric Cancer
Drug: mistletoe extract
Drug: doxifluridine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Abnoba Gmbh:

Primary Outcome Measures:
  • Quality of Life [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

    EORTC Quality of Life Questionnaires:

    1. QLQ-C30
    2. QLQ-STO22

Secondary Outcome Measures:
  • Immunomodulation [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    1. cytokine levels (TNF-alpha and interleukin-2)
    2. lymphocyte subsets (CD 16+/CD56+ and CD 19+)

  • Safety and tolerability [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    1. differential blood count
    2. liver functions tests
    3. adverse events

Enrollment: 32
Study Start Date: March 2006
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Didox
Experimental: doxifluridine + mistletoe extract
oral chemotherapy with the 5-FU prodrug doxifluridine + mistletoe extract as subcutaneous injection
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
Drug: doxifluridine
600 - 900 mg per day orally, depending on weight and status of the patient
Other Name: Didox


Ages Eligible for Study:   19 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01401075

Korea, Republic of
ASAN Medical Center
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Abnoba Gmbh
Principal Investigator: Byung-Sik Kim, Professor ASAN Medical Center, Seoul
  More Information

Responsible Party: Abnoba Gmbh
ClinicalTrials.gov Identifier: NCT01401075     History of Changes
Other Study ID Numbers: AB-AVQ20-1.0 
Study First Received: July 22, 2011
Last Updated: November 6, 2012
Health Authority: Korea: Ministry for Health and Welfare

Keywords provided by Abnoba Gmbh:
Quality of Life
Viscum album

Additional relevant MeSH terms:
Stomach Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Neoplasms by Site
Stomach Diseases
Viscum album peptide
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Appetite Stimulants
Central Nervous System Agents
Central Nervous System Stimulants
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2016