Does prophylactic treatment with proteolytic enzymes reduce acute toxicity of adjuvant pelvic irradiation? Results of a double-blind randomized trial

Radiotherapy and Oncology

Volumn 65, Issue 1, 2002, Pages 17-22

  Martin, Thomas ^a   Uhder, Kerstin ^a   Kurek, Ralf ^a   Roeddiger, Sandra ^a   Schneider, Lida ^a   Vogt, Hans Georg ^a   Heyd, Reinhard ^a   Zamboglou, Nikolaos ^a  

^a Klinikum Offenbach GmbH   (Germany)

Author keywords

Acute toxicity; Pelvic irradiation; Proteolytic enzymes

Indexed keywords

CHYMOTRYPSIN; PAPAIN; PLACEBO; PROTEINASE; TRYPSIN;

ADULT; ARTICLE; CLINICAL TRIAL; COMPUTER ASSISTED TOMOGRAPHY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DISEASE DURATION; DISEASE SEVERITY; FATIGUE; FEMALE; HUMAN; IRRADIATION; MAJOR CLINICAL STUDY; MALE; NAUSEA; PELVIS; PRIORITY JOURNAL; PROPHYLAXIS; RADIATION DOSE; RADIATION INJURY; RANDOMIZED CONTROLLED TRIAL; SURGICAL TECHNIQUE; TECHNIQUE; VOMITING;

CHYMOTRYPSIN; COMBINED MODALITY THERAPY; DIARRHEA; DOUBLE-BLIND METHOD; DRUG COMBINATIONS; FATIGUE; FEMALE; HUMANS; MALE; MIDDLE AGED; NAUSEA; PANCREATIC EXTRACTS; PAPAIN; PELVIC NEOPLASMS; PEPTIDE HYDROLASES; RADIATION INJURIES; RADIOTHERAPY, ADJUVANT; SKIN DISEASES; THYMUS EXTRACTS; TREATMENT OUTCOME; TRYPSIN; VOMITING;

EID: 0036804342     PISSN: 01678140     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0167-8140(02)00192-5     Document Type: Article

References (24)

1. Classen J., Belka C., Paulsen F., et al. Radiation-induced gastrointestinal toxicity. Pathophysiology approaches to treatment and prophylaxis. Strahlenther Onkol. 174:(3):1998;85-89.
2. Dale P. Efficacy and Tolerance of Wobe-Mugos E in Reducing Side-Effects of Radiation Therapy in Locally Advanced Cervical Cancer. Gerestried, Germany: MUCOS Pharma GmbH and Co, 1998 (data on file).
3. Eisenberg D.M., Davis R.B., Ettner S.L., et al. Trends in alternative medicine use in the United States, 1990-1997. J Am Med Assoc. 280:1998;1569-1575.
4. Fisher P., Ward A. Complementary medicine in Europe. Br Med J. 309:1994;107-111.
5. Fujisaki S., Fujisaki Y., Yoshida J.L., et al. Biochemical aspects of proteinase treatment on chronic inflammation. J Otolaryngol Jpn. 88:1985;1061-1066.
6. Gallagher M.J., Brereton H.D., Rostock R.A., et al. A prospective study of treatment techniques to minimize the volume of pelvic small bowel with reduction of acute and late effects associated with pelvic irradiation. Int J Radiat Oncol Biol Phys. 12:1986;1565-1573.
7. Gujral MS, Patnaik PM. Efficacy and Safety of Wobe-Mugos E in Preventing Side-Effects of Radiation Therapy in Patients with Head and Neck Cancer. Gerestried, Germany: MUCOS Pharma GmbH and Co, 1998 (data on file).
8. Hamilton HE, Melville GS, Moss SA. Radioprotection of rodents with papain. USAF School of Aerospace Medicine, Aerospace Medical Division (AFSC), Brooks Air Force Base, Texas, 1969.
9. Kolstad P. The role of radiation in the treatment of endometrial cancer. Schulz K.D., King R.J.B., Pollow K., Taylor R.W., Endometrial cancer. 1987;129-135 Zuckschwerdt, München.
10. Lahousen M. Modification of liver parameters by adjuvant administration of proteolytic enzymes following chemotherapy in patients with ovarian carcinoma. Wien Med Wochenschr. 45:1995;663-668.
11. Leipner J., Saller R. Systemic enzyme therapy in oncology: effect and mode of action. Drugs. 59:2000;769-780.
12. MacLennan A.H., Wilson D.H., Taylor A.W. Prevalence and cost of alternative medicine in Australia. Lancet. 347:1996;569-573.
13. Miller R.C., Martenson J.A., Sargent D.J., et al. Acute treatment-related diarrhea during postoperative adjuvant therapy for high-risk rectal carcinoma. Int J Radiat Oncol Biol Phys. 41:1998;593-598.
14. Minsky B.D., Cohen A.M., Enker W.E., et al. Phase I trial of postoperative 5-FU, radiation therapy, and high-dose leucovorin for resectable rectal cancer. Int J Radiat Oncol Biol Phys. 22:1992;139-145.
15. Narhi L.W., Rhode M.F., Hunt P., et al. The limited proteolysis of tumor necrosis factor alpha. J Protein Chem. 8:1989;669-677.
16. NIH Consensus Developement Conference. Adjuvant therapy for patients with colon and rectal cancer. J Am Med Assoc. 264:1990;1444-1450.
17. Perez C.A., Kurman R.J., Stehman F.B., et al. Uterine cervix. Hoskins W.J., Perez C.A., Young R.C., Principles and practice of gynecologic oncology. 1992;591-662 J.B. Lippincott Co, Philadelphia, PA.
18. Popiela T. Wobe-Mugos E as additive therapy after surgical treatment of colorectal cancer patients in combination with chemotherapy. Gerestried, Germany: MUCOS Pharma GmbH and Co., 1999.
19. Sakalova A., Dedik L., Gazova S., et al. Survival analysis of an adjuvant therapy with oral enzymes in multiple myeloma patients (abstract). Br J Haematol. 102:1998;353.
20. Schwabe U., Paffrath D. Arzneiverordnungs report 1999. 2000;Springer, Berlin. p. 18-22.
21. Schedler M., Lind A., Schatzle W., et al. Adjuvant therapy with hydrolytic enzymes in oncology: a hopeful effort to avoid Bleomycin induced pneumotoxicity. J Cancer Res Clin Oncol. 16:(Suppl. 1):1990;11-14.
22. Stauder G., Beaufort F., Streichhan P. Strahlentherapeutische Nebenwirkungen bei Abdominalkrebspatienten und deren reduktion durch hydrolytische Enzympräparate. Dtsch Zschr Onkol. 23:1991;7-16.
23. Vinzenz K., Stauder U. Die Therapie der radiogenen Mukositis mit Enzymen. Vinzenz K., Waclawiczek H.W., Chirurgische Therapie von Kopf-Hals-Karzinomen. 1992;300-314 Springer, Berlin.
24. Wald M., Olejar T., Pouckova P., et al. Proteinases reduce metastatic dissemination and increase survival time in C57B16 mice with the Lewis lung carcinoma. Life Sci. 63:1998;237-243.