This site is intended for healthcare professionals
  • Home
  • /
  • Journals
  • /
  • Cancer; other and unspecified primary
  • /
  • Safe and effective deodorization of malodorous fun...
Journal

Safe and effective deodorization of malodorous fungating tumors using topical metronidazole 0.75 % gel (GK567): a multicenter, open-label, phase III study (RDT.07.SRE.27013).

Read time: 1 mins
Published:1st Jun 2016
Author: Watanabe K, Shimo A, Tsugawa K, Tokuda Y, Yamauchi H, Miyai E, Takemura K et al.
Availability: Free full text
Ref.:Support Care Cancer. 2016 Jun;24(6):2583-90.
DOI:10.1007/s00520-015-3067-0.

Purpose: Malignant fungating tumors are neoplastic tumors associated with skin ulcers, which are susceptible to microbial colonization. Bacterial infection and proliferation may lead to malodor causing distress to patients. Metronidazole-an effective agent against anaerobes-may contribute to deodorization and improvement in quality of life (QOL). This study investigated the efficacy and safety of topical metronidazole 0.75 % gel for alleviation of malodor in anaerobically infected fungating neoplastic tumors.

Methods: This was a multicenter, open-label, non-controlled, phase III study including subjects aged 20 years or older with cutaneous fungating tumors releasing malodor (minimum score of 2 (mildly offensive smell) on a scale from 0 (no smell) to 4 (extremely offensive smell) based on investigator's assessment). Subjects applied metronidazole 0.75 % gel once or twice daily at the investigator's discretion for 14 days. Success was defined as an odor score of 0 or 1 at day 14, as assessed by the investigator. Patient satisfaction was assessed using a satisfaction questionnaire. Adverse events (AEs) that occurred after application of metronidazole 0.75 % gel were also reported.

Results: A total of 21 subjects at a median age of 65.0 years were enrolled. The success rate of deodorization at day 14 was 95.2 % (20/21 subjects). The patient satisfaction assessment showed that 71.4 % (15/21) of subjects were markedly or moderately improved. The treatment was well tolerated with only two AE cases of skin neoplasm bleeding (one mild and one moderate).

Conclusions: Metronidazole 0.75 % gel is an effective and safe treatment for deodorization of malodorous fungating tumors.

 

Read abstract on library site

Access full article