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)
| Autor: | K. Tsugawa, Kazuhiro Watanabe, Arata Shimo, Yutaka Tokuda, Eriko Miyai, Akihiko Ikoma, Hideko Yamauchi, Kimitoshi Takemura, Seigo Nakamura |
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| Jazyk: | angličtina |
| Rok vydání: | 2015 |
| Předmět: |
Adult
Male medicine.medical_specialty Skin Neoplasms Administration Cutaneous 030207 dermatology & venereal diseases 03 medical and health sciences 0302 clinical medicine Patient satisfaction Quality of life Anti-Infective Agents Metronidazole Odor medicine Topical metronidazole Humans Adverse effect Malodorous fungating tumors Aged Skin Neoplasm business.industry Bacterial Infections Skin ulcer Middle Aged Dermatology Surgery Clinical trial Treatment Outcome Oncology Patient Satisfaction 030220 oncology & carcinogenesis Odorants Quality of Life Original Article Female Open label medicine.symptom business medicine.drug |
| Zdroj: | Supportive Care in Cancer |
| ISSN: | 1433-7339 0941-4355 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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