RCT With Adjuvant Mistletoe Treatment in Gastric Cancer Patients
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StaatusValmis
Sponsorid
Abnoba Gmbh
KLIINILISES UURINGUS: NCT01401075
BioSeek: nct01401075
Märksõnad
Abstraktne
Evaluation of safety and efficacy of a standardized mistletoe extract (abnobaVISCUM® Quercus, aVQ) in patients with gastric cancer receiving oral chemotherapy.
Kuupäevad
| Viimati kinnitatud: | 06/30/2011 |
| Esmalt esitatud: | 07/21/2011 |
| Hinnanguline registreerumine on esitatud: | 07/21/2011 |
| Esmalt postitatud: | 07/24/2011 |
| Viimane värskendus on esitatud: | 11/05/2012 |
| Viimati värskendus postitatud: | 11/06/2012 |
| Õppe tegelik alguskuupäev: | 02/28/2006 |
| Eeldatav esmane lõpetamise kuupäev: | 03/31/2008 |
| Eeldatav uuringu lõpetamise kuupäev: | 03/31/2008 |
Seisund või haigus
Gastric Cancer
Sekkumine / ravi
Drug: doxifluridine + mistletoe extract
Drug: doxifluridine
Faas
Faas 4
Käerühmad
| Arm | Sekkumine / ravi |
|---|---|
| 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 |
Abikõlblikkuse kriteeriumid
| Õppimiseks sobivad vanused | 19 Years To 19 Years |
| Uuringuks kõlblikud sood | All |
| Võtab vastu tervislikke vabatahtlikke | Jah |
| Kriteeriumid | 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 |
Tulemus
Esmased tulemusnäitajad
1. Quality of Life [24 weeks]
EORTC Quality of Life Questionnaires:
QLQ-C30
QLQ-STO22
Sekundaarsed tulemusmõõdud
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
