RCT With Adjuvant Mistletoe Treatment in Gastric Cancer Patients
Ní féidir ach le húsáideoirí cláraithe ailt a aistriú
Logáil Isteach / Cláraigh
Sábháiltear an nasc chuig an gearrthaisce
StádasCríochnaithe
Urraitheoirí
Abnoba Gmbh
TRIAIL CHLINICIÚIL: NCT01401075
BioSeek: nct01401075
Keywords
Coimriú
Evaluation of safety and efficacy of a standardized mistletoe extract (abnobaVISCUM® Quercus, aVQ) in patients with gastric cancer receiving oral chemotherapy.
Dátaí
| Fíoraithe Deireanach: | 06/30/2011 |
| Cuireadh isteach den chéad uair: | 07/21/2011 |
| Clárú Measta Curtha isteach: | 07/21/2011 |
| Arna chur suas ar dtús: | 07/24/2011 |
| Nuashonrú Deireanach Curtha isteach: | 11/05/2012 |
| Nuashonrú Deireanach Postáilte: | 11/06/2012 |
| Dáta Tosaigh an Staidéir Iarbhír: | 02/28/2006 |
| Dáta Críochnaithe Bunscoile Measta: | 03/31/2008 |
| Dáta Críochnaithe an Staid Mheasta: | 03/31/2008 |
Coinníoll nó galar
Gastric Cancer
Idirghabháil / cóireáil
Drug: doxifluridine + mistletoe extract
Drug: doxifluridine
Céim
Céim 4
Grúpaí Láimhe
| Lámh | Idirghabháil / cóireáil |
|---|---|
| Active Comparator: doxifluridine oral chemotherapy with the 5-FU prodrug doxifluridine | |
| Experimental: doxifluridine + mistletoe extract oral chemotherapy with the 5-FU prodrug doxifluridine + mistletoe extract as subcutaneous injection | Drug: doxifluridine + mistletoe extract subcutaneous injections thrice weekly with 1 ml in 4 increasing doses |
Critéir Incháilitheachta
| Aois Incháilithe le haghaidh Staidéir | 19 Years Chun 19 Years |
| Gnéas Incháilithe le haghaidh Staidéir | All |
| Glacann Oibrithe Deonacha Sláintiúla | Sea |
| Critéir | 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 |
Toradh
Bearta Toraidh Príomhúla
1. Quality of Life [24 weeks]
EORTC Quality of Life Questionnaires:
QLQ-C30
QLQ-STO22
Bearta Torthaí Tánaisteacha
1. Immunomodulation [24 weeks]
cytokine levels (TNF-alpha and interleukin-2)
lymphocyte subsets (CD 16+/CD56+ and CD 19+)
2. Safety and tolerability [24 weeks]
differential blood count
liver functions tests
adverse events
