Quality of life, immunomodulation and safety of adjuvant mistletoe treatment in patients with gastric carcinoma - a randomized, controlled pilot study

BMC Complement Altern Med. 2012 Oct 3;12:172. doi: 10.1186/1472-6882-12-172.

Abstract

Background: Mistletoe (Viscum album L.) extracts are widely used in complementary cancer therapy. Aim of this study was to evaluate safety and efficacy of a standardized mistletoe extract (abnobaVISCUM(®) Quercus, aVQ) in patients with gastric cancer.

Patients and methods: 32 operated gastric cancer patients (stage Ib or II) who were waiting for oral chemotherapy with the 5-FU prodrug doxifluridine were randomized 1:1 to receive additional therapy with aVQ or no additional therapy. aVQ was injected subcutaneously three times per week from postoperative day 7 to week 24 in increasing doses. EORTC QLQ-C30 and -STO22 Quality of Life questionnaire, differential blood count, liver function tests, various cytokine levels (tumor necrosis factor (TNF)-alpha, interleukin (IL)-2), CD 16(+)/CD56(+) and CD 19(+) lymphocytes were analyzed at baseline and 8, 16 and 24 weeks later.

Results: Global health status (p <0.01), leukocyte- and eosinophil counts (p ≤0.01) increased significantly in the treatment group compared to the control group. Diarrhea was less frequently reported (7% vs. 50%, p=0.014) in the intervention group. There was no significant treatment effect on levels of TNF-alpha, IL-2, CD16(+)/CD56(+) and CD 19(+) lymphocytes and liver function tests measured by ANOVA.

Conclusion: Additional treatment with aVQ is safe and was associated with improved QoL of gastric cancer patients. ClinicalTrials.Gov Registration number NCT01401075.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Antineoplastic Agents / adverse effects
  • Antineoplastic Agents / therapeutic use
  • Antineoplastic Agents, Phytogenic / administration & dosage
  • Antineoplastic Agents, Phytogenic / adverse effects
  • Carcinoma / drug therapy*
  • Carcinoma / immunology*
  • Cytokines / immunology
  • Drug Therapy, Combination
  • Female
  • Fluorouracil / therapeutic use
  • Humans
  • Immunomodulation / drug effects
  • Injections, Subcutaneous
  • Male
  • Middle Aged
  • Mistletoe / chemistry*
  • Pilot Projects
  • Plant Extracts / administration & dosage*
  • Plant Extracts / adverse effects
  • Quality of Life*
  • Stomach Neoplasms / drug therapy*
  • Stomach Neoplasms / immunology*

Substances

  • Antineoplastic Agents
  • Antineoplastic Agents, Phytogenic
  • Cytokines
  • Plant Extracts
  • Fluorouracil

Associated data

  • ClinicalTrials.gov/NCT01401075