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)

• Published in: Supportive care in cancer Vol. 24; no. 6; pp. 2583 - 2590
• Main Authors: Watanabe, Kazuhiro, Shimo, Arata, Tsugawa, Kouichiro, Tokuda, Yutaka, Yamauchi, Hideko, Miyai, Eriko, Takemura, Kimitoshi, Ikoma, Akihiko, Nakamura, Seigo
• Format: Journal Article
• Language: English
• Published: Berlin/Heidelberg Springer Berlin Heidelberg 01.06.2016; Springer Nature B.V
• Subjects: Administration, Cutaneous; Adult; Aged; Anti-Infective Agents - adverse effects; Anti-Infective Agents - therapeutic use; Bacterial infections; Bacterial Infections - drug therapy; Bacterial Infections - microbiology; Bacterial Infections - pathology; Clinical trials; Drug therapy; Female; Humans; Male; Medicine; Medicine & Public Health; Metronidazole - adverse effects; Metronidazole - therapeutic use; Middle Aged; Nursing; Nursing Research; Odorants - prevention & control; Odors; Oncology; Original; Original Article; Pain Medicine; Patient Satisfaction; Quality of Life; Rehabilitation Medicine; Skin diseases; Skin Neoplasms - drug therapy; Skin Neoplasms - microbiology; Skin Neoplasms - pathology; Skin Ulcer - drug therapy; Skin Ulcer - microbiology; Skin Ulcer - pathology; Treatment Outcome; Tumors; Ulcers; Malodorous fungating tumors; Clinical trial; Topical metronidazole; Odor; Skin ulcer
• ISSN: 0941-4355; 1433-7339; 1433-7339
• 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.