Back to resultsRCT With Adjuvant Mistletoe Treatment in Gastric Cancer Patients
Primary Purpose
Gastric Cancer
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
mistletoe extract
doxifluridine
Sponsored by
About this trial
This is an interventional supportive care trial for Gastric Cancer focused on measuring Quality of Life, QoL, EORTC QLQ-C30, EORTC QLQ-STO22, 5-FU, Viscum album
Eligibility Criteria
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
Sites / Locations
- ASAN Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
doxifluridine
doxifluridine + mistletoe extract
Arm Description
oral chemotherapy with the 5-FU prodrug doxifluridine
oral chemotherapy with the 5-FU prodrug doxifluridine + mistletoe extract as subcutaneous injection
Outcomes
Primary Outcome Measures
Quality of Life
EORTC Quality of Life Questionnaires:
QLQ-C30
QLQ-STO22
Secondary Outcome Measures
Immunomodulation
cytokine levels (TNF-alpha and interleukin-2)
lymphocyte subsets (CD 16+/CD56+ and CD 19+)
Safety and tolerability
differential blood count
liver functions tests
adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01401075
Brief Title
RCT With Adjuvant Mistletoe Treatment in Gastric Cancer Patients
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abnoba Gmbh
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Evaluation of safety and efficacy of a standardized mistletoe extract (abnobaVISCUM® Quercus, aVQ) in patients with gastric cancer receiving oral chemotherapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
Quality of Life, QoL, EORTC QLQ-C30, EORTC QLQ-STO22, 5-FU, Viscum album
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
doxifluridine
Arm Type
Active Comparator
Arm Description
oral chemotherapy with the 5-FU prodrug doxifluridine
Arm Title
doxifluridine + mistletoe extract
Arm Type
Experimental
Arm Description
oral chemotherapy with the 5-FU prodrug doxifluridine + mistletoe extract as subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
mistletoe extract
Other Intervention Name(s)
abnobaVISCUM Quercus 0.02 mg, abnobaVISCUM Quercus 0.2 mg, abnobaVISCUM Quercus 2 mg, abnobaVISCUM Quercus 20 mg
Intervention Description
subcutaneous injections thrice weekly with 1 ml in 4 increasing doses
Intervention Type
Drug
Intervention Name(s)
doxifluridine
Other Intervention Name(s)
Didox
Intervention Description
600 - 900 mg per day orally, depending on weight and status of the patient
Primary Outcome Measure Information:
Title
Quality of Life
Description
EORTC Quality of Life Questionnaires:
QLQ-C30
QLQ-STO22
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Immunomodulation
Description
cytokine levels (TNF-alpha and interleukin-2)
lymphocyte subsets (CD 16+/CD56+ and CD 19+)
Time Frame
24 weeks
Title
Safety and tolerability
Description
differential blood count
liver functions tests
adverse events
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Byung-Sik Kim, Professor
Organizational Affiliation
ASAN Medical Center, Seoul
Official's Role
Principal Investigator
Facility Information:
Facility Name
ASAN Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
23033982
Citation
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.
Results Reference
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RCT With Adjuvant Mistletoe Treatment in Gastric Cancer Patients
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