[Influence of ML-1 standardized mistletoe extract on the quality of life in head and neck cancer patients]

HNO. 2006 Apr;54(4):277-86. doi: 10.1007/s00106-005-1318-y.
[Article in German]


Background: ML-1 standardized mistletoe extracts have been recommended for increasing the health-related quality of life in cancer patients.

Patients and methods: The EORTC questionnaire QLQ-C30((V2)) was given to a randomly chosen subgroup of 399 patients of a prospective, randomized, open, multi-center trial. A total of 200 patients from this trial were randomized for ML-1 treatment (1 ng/kg body weight ML-1 was injected subcutaneously twice weekly over a 60-week period. Treatment cycles of 12 weeks were followed by a break of 4 weeks (between weeks 12-16, 28-32, and 44-48)). The remaining 199 patients formed the control group.

Results: Patients completed questionnaires before the start of their treatments at week 0 and continued until week 156. The compliance rate was high: 3611 questionnaires were available, which equals a median of nine longitudinal measurements per patient between weeks 0 and 156. Analysis did not indicate any improvement in the quality of life for either group. A significant decrease in quality of life, however, was seen in patients undergoing radiotherapy. In these patients, the global state of health was reduced and four symptom scales were significantly worse.

Conclusion: Our results demonstrated no improvement in the quality of life in head and neck cancer patients when treated with ML-1 extract.

Publication types

  • English Abstract
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Aged
  • Antineoplastic Agents, Phytogenic / adverse effects
  • Antineoplastic Agents, Phytogenic / standards
  • Antineoplastic Agents, Phytogenic / therapeutic use*
  • Chemotherapy, Adjuvant
  • Combined Modality Therapy
  • Drug Administration Schedule
  • Female
  • Follow-Up Studies
  • Humans
  • Injections, Subcutaneous
  • Male
  • Middle Aged
  • Otorhinolaryngologic Neoplasms / drug therapy*
  • Otorhinolaryngologic Neoplasms / psychology
  • Otorhinolaryngologic Neoplasms / radiotherapy
  • Phytotherapy / psychology*
  • Plant Extracts / adverse effects
  • Plant Extracts / standards
  • Plant Extracts / therapeutic use*
  • Plant Preparations / adverse effects
  • Plant Preparations / standards
  • Plant Preparations / therapeutic use*
  • Plant Proteins / adverse effects
  • Plant Proteins / standards
  • Plant Proteins / therapeutic use*
  • Prospective Studies
  • Quality of Life / psychology*
  • Radiotherapy, Adjuvant
  • Ribosome Inactivating Proteins, Type 2
  • Surveys and Questionnaires
  • Toxins, Biological / adverse effects
  • Toxins, Biological / standards
  • Toxins, Biological / therapeutic use*


  • Antineoplastic Agents, Phytogenic
  • Plant Extracts
  • Plant Preparations
  • Plant Proteins
  • Ribosome Inactivating Proteins, Type 2
  • Toxins, Biological
  • mistletoe lectin I