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RCT With Adjuvant Mistletoe Treatment in Gastric Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01401075
Recruitment Status : Completed
First Posted : July 25, 2011
Last Update Posted : November 7, 2012
Information provided by (Responsible Party):
Abnoba Gmbh

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

Condition or disease Intervention/treatment Phase
Gastric Cancer Drug: mistletoe extract Drug: doxifluridine Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : March 2006
Actual Primary Completion Date : April 2008
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

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 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

Primary Outcome Measures :
  1. Quality of Life [ Time Frame: 24 weeks ]

    EORTC Quality of Life Questionnaires:

    1. QLQ-C30
    2. QLQ-STO22

Secondary Outcome Measures :
  1. Immunomodulation [ Time Frame: 24 weeks ]
    1. cytokine levels (TNF-alpha and interleukin-2)
    2. lymphocyte subsets (CD 16+/CD56+ and CD 19+)

  2. Safety and tolerability [ Time Frame: 24 weeks ]
    1. differential blood count
    2. liver functions tests
    3. adverse events

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   19 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01401075

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Korea, Republic of
ASAN Medical Center
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Abnoba Gmbh
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Principal Investigator: Byung-Sik Kim, Professor ASAN Medical Center, Seoul
Publications of Results:
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Responsible Party: Abnoba Gmbh Identifier: NCT01401075    
Other Study ID Numbers: AB-AVQ20-1.0
First Posted: July 25, 2011    Key Record Dates
Last Update Posted: November 7, 2012
Last Verified: July 2011
Keywords provided by Abnoba Gmbh:
Quality of Life
Viscum album
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Viscum album peptide
Antineoplastic Agents
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Appetite Stimulants
Central Nervous System Stimulants