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