RCT With Adjuvant Mistletoe Treatment in Gastric Cancer Patients
- Registration Number
- NCT01401075
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description doxifluridine doxifluridine oral chemotherapy with the 5-FU prodrug doxifluridine doxifluridine + mistletoe extract mistletoe extract oral chemotherapy with the 5-FU prodrug doxifluridine + mistletoe extract as subcutaneous injection doxifluridine + mistletoe extract doxifluridine oral chemotherapy with the 5-FU prodrug doxifluridine + mistletoe extract as subcutaneous injection
- Primary Outcome Measures
Name Time Method Quality of Life 24 weeks EORTC Quality of Life Questionnaires:
1. QLQ-C30
2. QLQ-STO22
- Secondary Outcome Measures
Name Time Method Immunomodulation 24 weeks 1. cytokine levels (TNF-alpha and interleukin-2)
2. lymphocyte subsets (CD 16+/CD56+ and CD 19+)Safety and tolerability 24 weeks 1. differential blood count
2. liver functions tests
3. adverse events
Trial Locations
- Locations (1)
ASAN Medical Center
🇰🇷Seoul, Korea, Republic of