RCT With Adjuvant Mistletoe Treatment in Gastric Cancer Patients

Abnoba

Status and phase: Completed; Phase 4

Conditions: Gastric Cancer

Treatments: Drug: mistletoe extract; Drug: doxifluridine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01401075

AB-AVQ20-1.0

Details and patient eligibility

About

Evaluation of safety and efficacy of a standardized mistletoe extract (abnobaVISCUM® Quercus, aVQ) in patients with gastric cancer receiving oral chemotherapy.

Enrollment: 32 patients

Sex: All

Ages: 19 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

doxifluridine

Active Comparator group

Description:

oral chemotherapy with the 5-FU prodrug doxifluridine

Treatment:

Drug: doxifluridine

doxifluridine + mistletoe extract

Experimental group

Description:

oral chemotherapy with the 5-FU prodrug doxifluridine + mistletoe extract as subcutaneous injection

Treatment:

Drug: doxifluridine

Drug: mistletoe extract