RCT With Adjuvant Mistletoe Treatment in Gastric Cancer Patients

Abnoba Gmbh32 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Gastric Cancer

Interventions

mistletoe extractDRUG

subcutaneous injections thrice weekly with 1 ml in 4 increasing doses

doxifluridineDRUG

600 - 900 mg per day orally, depending on weight and status of the patient

Eligibility

Sex: ALLMin age: 19 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

ASAN Medical Center

Seoul, South Korea

Outcomes

Primary Outcomes

Quality of Life

EORTC Quality of Life Questionnaires: 1. QLQ-C30 2. QLQ-STO22

Time frame: 24 weeks

Secondary Outcomes

Immunomodulation

1. cytokine levels (TNF-alpha and interleukin-2) 2. lymphocyte subsets (CD 16+/CD56+ and CD 19+)

Time frame: 24 weeks

Safety and tolerability

1. differential blood count 2. liver functions tests 3. adverse events

Time frame: 24 weeks

Data from ClinicalTrials.gov

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