RCT With Adjuvant Mistletoe Treatment in Gastric Cancer Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abnoba Gmbh
ClinicalTrials.gov Identifier:
NCT01401075
First received: July 22, 2011
Last updated: November 6, 2012
Last verified: July 2011
  Purpose

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

  Eligibility

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

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
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, see Learn About Clinical Studies.

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

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

Publications:
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, Welfare and Family Affairs

Keywords provided by Abnoba Gmbh:
Quality of Life
QoL
EORTC QLQ-C30
EORTC QLQ-STO22
5-FU
Viscum album

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

ClinicalTrials.gov processed this record on July 29, 2014