RCT With Adjuvant Mistletoe Treatment in Gastric Cancer Patients

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01401075

Enrollment

Registered

2011-07-25

Start date

2006-03-31

Completion date

2008-04-30

Last updated

2012-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer

Keywords

Quality of Life, QoL, EORTC QLQ-C30, EORTC QLQ-STO22, 5-FU, Viscum album

Brief summary

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

Interventions

DRUGmistletoe extract

subcutaneous injections thrice weekly with 1 ml in 4 increasing doses

DRUGdoxifluridine

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Quality of Life	24 weeks	EORTC Quality of Life Questionnaires: 1. QLQ-C30 2. QLQ-STO22

Secondary

Measure	Time frame	Description
Immunomodulation	24 weeks	1. cytokine levels (TNF-alpha and interleukin-2) 2. lymphocyte subsets (CD 16+/CD56+ and CD 19+)
Safety and tolerability	24 weeks	1. differential blood count 2. liver functions tests 3. adverse events

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026