Does Prophylactic Treatment With Proteolytic Enzymes Reduce Acute Toxicity of Adjuvant Pelvic Irradiation? Results of a Double-Blind Randomized Trial

Radiother Oncol. 2002 Oct;65(1):17-22. doi: 10.1016/s0167-8140(02)00192-5.

Abstract

Purpose: Does prophylactic treatment with proteolytic enzymes reduce acute toxicity of adjuvant pelvic radiotherapy?

Material and methods: Fifty-six patients with an indication for adjuvant pelvic irradiation after curative surgery were double-blind randomized. All patients took 3 x 4 capsules study medication daily during radiotherapy. Twenty-eight patients in the enzyme group (EG) received capsules containing papain, trypsin and chymotrypsin, 28 in the placebo group (PG) received placebo capsules. All patients were irradiated with 5 x 1.8 Gy weekly to 50.4 Gy using four-field-box technique after CT-based planning. Primary objective was the grade of diarrhea, nausea, vomiting, fatigue and epitheliolysis during radiotherapy. Secondary objectives were the number of supportive medications and treatment interruptions due to acute toxicity.

Results: None/mild diarrhea: 43% EG, 64% PG. Moderate/severe diarrhea: 57% EG, 36% PG (P = 0.11). Mean duration: 11 days in EG, 10 days in PG. None/mild nausea: 93% EG, 93% PG. Moderate/severe nausea: 7% EG, 7% PG. None/mild vomiting: 100% EG, 97% PG. None/mild fatigue: 82% EG, 93% PG. Moderate/severe fatigue: 18% EG, 7% PG (P = 0.23). None/mild epitheliolysis: 75% EG, 93% PG. Moderate/severe epitheliolysis: 25% EG, 7% PG (P = 0.16). Treatment interruption (mean days): 2.44 in EG, 1.46 in PG. Number of supportive medication: 29 in EG, 19 in PG.

Conclusions: The prophylactic use of proteolytic enzymes does not reduce acute toxicities, treatment interruptions and number of supportive medication and therefore does not improve tolerance of adjuvant pelvic radiotherapy.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial

MeSH terms

  • Chymotrypsin*
  • Combined Modality Therapy
  • Diarrhea / prevention & control
  • Double-Blind Method
  • Drug Combinations
  • Fatigue / prevention & control
  • Female
  • Humans
  • Male
  • Middle Aged
  • Nausea / prevention & control
  • Pancreatic Extracts / therapeutic use*
  • Papain / therapeutic use*
  • Pelvic Neoplasms / radiotherapy*
  • Pelvic Neoplasms / surgery
  • Peptide Hydrolases / therapeutic use*
  • Radiation Injuries / prevention & control*
  • Radiotherapy, Adjuvant / adverse effects
  • Skin Diseases / prevention & control
  • Thymus Extracts / therapeutic use*
  • Treatment Outcome
  • Trypsin*
  • Vomiting / prevention & control

Substances

  • Drug Combinations
  • Pancreatic Extracts
  • Thymus Extracts
  • chymotrypsin, papain, trypsin drug combination
  • Peptide Hydrolases
  • Chymotrypsin
  • Trypsin
  • Papain