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

July 22, 2011
November 6, 2012
March 2006
April 2008   (final data collection date for primary outcome measure)
Quality of Life [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

EORTC Quality of Life Questionnaires:

  1. QLQ-C30
  2. QLQ-STO22
Same as current
Complete list of historical versions of study NCT01401075 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
RCT With Adjuvant Mistletoe Treatment in Gastric Cancer Patients
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Gastric Cancer
  • 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
  • Active Comparator: doxifluridine
    oral chemotherapy with the 5-FU prodrug doxifluridine
    Intervention: Drug: doxifluridine
  • Experimental: doxifluridine + mistletoe extract
    oral chemotherapy with the 5-FU prodrug doxifluridine + mistletoe extract as subcutaneous injection
    Interventions:
    • Drug: mistletoe extract
    • Drug: doxifluridine
Kim KC, Yook JH, Eisenbraun J, Kim BS, Huber R. Quality of life, immunomodulation and safety of adjuvant mistletoe treatment in patients with gastric carcinoma - a randomized, controlled pilot study. BMC Complement Altern Med. 2012 Oct 3;12:172. doi: 10.1186/1472-6882-12-172.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
April 2008
April 2008   (final data collection date for primary outcome measure)

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
Both
19 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01401075
AB-AVQ20-1.0
No
Abnoba Gmbh
Abnoba Gmbh
Not Provided
Principal Investigator: Byung-Sik Kim, Professor ASAN Medical Center, Seoul
Abnoba Gmbh
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP