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Completed

NCT Number: NCT01401075

RCT With Adjuvant Mistletoe Treatment in Gastric Cancer Patients

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

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Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

19 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

ASAN Medical Center

Seoul, 138-736, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mistletoe extract

Drug

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

doxifluridine

Drug

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

Other names: Didox

Primary outcomes

  1. Quality of Life

    Time frame: 24 weeks

    EORTC Quality of Life Questionnaires:

    • QLQ-C30
    • QLQ-STO22

Secondary outcomes

  1. Immunomodulation

    Time frame: 24 weeks

    • cytokine levels (TNF-alpha and interleukin-2)
    • lymphocyte subsets (CD 16+/CD56+ and CD 19+)

  2. Safety and tolerability

    Time frame: 24 weeks

    • differential blood count
    • liver functions tests
    • adverse events

Sponsors and collaborators

Lead sponsor

Abnoba Gmbh

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Jul 25, 2011
Registry last updated
Nov 7, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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