Gastric CancerPhase 4NCT01401075
RCT With Adjuvant Mistletoe Treatment in Gastric Cancer Patients
A Phase 4 study testing mistletoe extract and doxifluridine in people with Gastric Cancer, run by Abnoba Gmbh at 1 site in South Korea.
Trial summary
Evaluation of safety and efficacy of a standardized mistletoe extract (abnobaVISCUM® Quercus, aVQ) in patients with gastric cancer receiving oral chemotherapy. Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- mistletoe extract and doxifluridine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2006to Apr 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- postoperative UICC stage Ib/II gastric carcinoma
- indication for oral chemotherapy with doxifluridine
- ECOG performance status 0 or 1
- normal liver and kidney function
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
Evaluation of safety and efficacy of a standardized mistletoe extract (abnobaVISCUM® Quercus, aVQ) in patients with gastric cancer receiving oral chemotherapy.
- Conditions
- Gastric Cancer
- Being tested
- mistletoe extract, doxifluridine
- Keywords
- Quality of Life, QoL, EORTC QLQ-C30, EORTC QLQ-STO22, 5-FU, Viscum album
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mistletoe extractDrug
Also called abnobaVISCUM Quercus 0.02 mg, abnobaVISCUM Quercus 0.2 mg, abnobaVISCUM Quercus 2 mg, abnobaVISCUM Quercus 20 mg
subcutaneous injections thrice weekly with 1 ml in 4 increasing doses
doxifluridineDrug
Also called Didox
600 - 900 mg per day orally, depending on weight and status of the patient
| Study group | Role | What they receive |
|---|---|---|
| doxifluridine | Active comparator | oral chemotherapy with the 5-FU prodrug doxifluridine Receives: Drug: doxifluridine |
| doxifluridine + mistletoe extract | Experimental | oral chemotherapy with the 5-FU prodrug doxifluridine + mistletoe extract as subcutaneous injection Receives: Drug: mistletoe extract; Drug: doxifluridine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life
EORTC Quality of Life Questionnaires:
- QLQ-C30
- QLQ-STO22
Measured: 24 weeks
Secondary outcomes (2)
Immunomodulation
- cytokine levels (TNF-alpha and interleukin-2)
- lymphocyte subsets (CD 16+/CD56+ and CD 19+)
Measured: 24 weeks
Safety and tolerability
- differential blood count
- liver functions tests
- adverse events
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2011 (estimated)
- Study startMar 2006
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abnoba Gmbh
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Byung-Sik Kim, Professor, Principal investigator, ASAN Medical Center, Seoul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01401075
- Sponsor's protocol ID
- AB-AVQ20-1.0
- Status last verified
- Jul 2011
- First submitted
- 22 Jul 2011
- Last updated
- 7 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23033982
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01401075
- Acronym / sponsor ID
- AB-AVQ20-1.0
- Conditions
- Gastric Cancer
- Keywords
- Quality of Life, QoL, EORTC QLQ-C30, EORTC QLQ-STO22, 5-FU, Viscum album
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Abnoba GmbhIndustry (pharma, biotech, devices)
- Study start
- Mar 2006
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 25 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of safety and efficacy of a standardized mistletoe extract (abnobaVISCUM® Quercus, aVQ) in patients with gastric cancer receiving oral chemotherapy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| doxifluridine | Active comparator | Drug: doxifluridineoral chemotherapy with the 5-FU prodrug doxifluridine |
| doxifluridine + mistletoe extract | Experimental | Drug: mistletoe extract, Drug: doxifluridineoral chemotherapy with the 5-FU prodrug doxifluridine + mistletoe extract as subcutaneous injection |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- postoperative UICC stage Ib/II gastric carcinoma
- indication for oral chemotherapy with doxifluridine
- ECOG performance status 0 or 1
- normal liver and kidney function
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mistletoe extractAlso: abnobaVISCUM Quercus 0.02 mg, abnobaVISCUM Quercus 0.2 mg, abnobaVISCUM Quercus 2 mg, abnobaVISCUM Quercus 20 mgsubcutaneous injections thrice weekly with 1 ml in 4 increasing doses | Drug | doxifluridine + mistletoe extract |
| doxifluridineAlso: Didox600 - 900 mg per day orally, depending on weight and status of the patient | Drug | doxifluridine, doxifluridine + mistletoe extract |
Primary outcome
Quality of Life
Time frame: 24 weeks
EORTC Quality of Life Questionnaires: 1. QLQ-C30 2. QLQ-STO22
2 secondary outcomes
Immunomodulation
Time frame: 24 weeks
Safety and tolerability
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2012.
- Results publication: PubMed 23033982Kim 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Byung-Sik Kim, Professor principal investigator
ASAN Medical Center, Seoul
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing mistletoe extract and doxifluridine in people with Gastric Cancer, run by Abnoba Gmbh at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01401075, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2012.