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
1 other identifier
interventional
32
1 country
1
Brief Summary
Evaluation of safety and efficacy of a standardized mistletoe extract (abnobaVISCUM® Quercus, aVQ) in patients with gastric cancer receiving oral chemotherapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 gastric-cancer
Started Mar 2006
Typical duration for phase_4 gastric-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
July 22, 2011
CompletedFirst Posted
Study publicly available on registry
July 25, 2011
CompletedNovember 7, 2012
July 1, 2011
2.1 years
July 22, 2011
November 6, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Quality of Life
EORTC Quality of Life Questionnaires: 1. QLQ-C30 2. QLQ-STO22
24 weeks
Secondary Outcomes (2)
Immunomodulation
24 weeks
Safety and tolerability
24 weeks
Study Arms (2)
doxifluridine
ACTIVE COMPARATORoral chemotherapy with the 5-FU prodrug doxifluridine
doxifluridine + mistletoe extract
EXPERIMENTALoral chemotherapy with the 5-FU prodrug doxifluridine + mistletoe extract as subcutaneous injection
Interventions
subcutaneous injections thrice weekly with 1 ml in 4 increasing doses
600 - 900 mg per day orally, depending on weight and status of the patient
Eligibility Criteria
You may qualify if:
- postoperative UICC stage Ib/II gastric carcinoma
- indication for oral chemotherapy with doxifluridine
- ECOG performance status 0 or 1
- normal liver and kidney function
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abnoba Gmbhlead
Study Sites (1)
ASAN Medical Center
Seoul, 138-736, South Korea
Related Publications (1)
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.
PMID: 23033982RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Byung-Sik Kim, Professor
ASAN Medical Center, Seoul
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 22, 2011
First Posted
July 25, 2011
Study Start
March 1, 2006
Primary Completion
April 1, 2008
Study Completion
April 1, 2008
Last Updated
November 7, 2012
Record last verified: 2011-07