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
Phase 4
19 Years
70 Years
19 Years
70 Years
Not Enrolling
Both
Gastric Cancer
Both
Gastric Cancer
Trial Information
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
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Outcome Measure:
Quality of Life
Outcome Description:
EORTC Quality of Life Questionnaires: QLQ-C30 QLQ-STO22
Outcome Time Frame:
24 weeks
Safety Issue:
No
Principal Investigator
Byung-Sik Kim, Professor
Investigator Role:
Principal Investigator
Investigator Affiliation:
ASAN Medical Center, Seoul
Authority:
Korea: Ministry for Health, Welfare and Family Affairs
Study ID:
AB-AVQ20-1.0
NCT ID:
NCT01401075
Start Date:
March 2006
Completion Date:
April 2008
Related Keywords:
- Gastric Cancer
- Quality of Life
- QoL
- EORTC QLQ-C30
- EORTC QLQ-STO22
- 5-FU
- Viscum album
- Stomach Neoplasms
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