Clinical efficacy of the external preparation Metronidazole in the treatment of malodor associated with advanced and recurrent breast cancer

Shinano, Hiromi; Watanabe, Kazuhiro; Nakamura, Seigo; Tamahashi, Yoko; Tsuchiya, Masao; Kizu, Junko; Inoue, Tadao

doi:10.2512/jspm.2.218

Palliat Care Res

2007

DOI: 10.2512/jspm.2.218

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Clinical efficacy of the external preparation Metronidazole in the treatment of malodor associated with advanced and recurrent breast cancer

Hiromi Shinano¹,

Kazuhiro Watanabe²,

Seigo Nakamura³

et al.

Abstract: 信濃裕美 1) , 渡部一宏 1) 2) , 中村清吾 3) , 玉橋容子 4) , 土屋雅勇 5) , 木津純子 2) , 井上忠夫 1) 1) 聖路加国際病院薬剤部, 2) 共立薬科大学実務薬学講座, 3) 聖路加国際病院乳腺外科, 4) 聖路加国際病院看護部, 5) 帝京大学薬学部

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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)

Watanabe

Shimo

Tsugawa

et al. 2015

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PurposeMalignant 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.MethodsThis 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.ResultsA 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).ConclusionsMetronidazole 0.75 % gel is an effective and safe treatment for deodorization of malodorous fungating tumors.

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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)

Watanabe

Shimo

Tsugawa

et al. 2015

Support Care Cancer

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A patient in whom metronidazole was effective for cancerous malodor related to pleural metastasis, involving the thoracic wall, from gastric cancer

Sawada¹,

Hatachi²,

Yasuda³

et al. 2009

Palliat Care Res

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Case Study on Usefulness of Clindamycin-pate in Treatment of Extensive Malodorous Effusion from Malignant Melanoma and Evaluation of Water Absorbability of Ointment Base

Shida¹,

Yamakawa²,

Konno³

et al. 2011

Iryo Yakugaku (Japanese Journal of Pharmaceutical Health Care a

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Cancerous malodor remarkably decreases the quality of life of patients. However, in the absence of a standard topical therapy for it, we have to use a hospital preparation.We report the case of a patient with extensive malodorous malignant effusion who was successfully treated with clindamycin-pate. The patient was a 49-year-old man who had malignant melanoma. The melanoma had spread to the intracranial region and left axillary and para-aortic lymph nodes. The metastatic lesion in the left axillary lymph node released a strong odor. Cadexomer-iodine ointment was first used for treatment of the lesion but was ineffective against the effluvium so we changed it to clindamycin-pate.In a survey of hospital staff, 87.5% stated that the foul smell had disappeared after treating the patient with clindamycin-pate. Clindamycin-pate has been seen to exhibit significant antimicrobial activity against gram-positive and anaerobic bacteria and this is probably the reason for its effectiveness against the foul smell. It also absorbed a considerable amount of the effusion, eliminating the need to use carboxymethylcellulose sodium salt (CMC-Na). Therefore, clindamycin-pate is considered to be an effective adjuvant therapy for controlling malodorous effusion in cancer patients. Furthermore, in a comparison of hydrophilia with various external preparations, clindamycin-pate was found to have remarkable moisture absorption capability, providing further evidence of its usefulness in the control of effusions.

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Clinical efficacy of the external preparation Metronidazole in the treatment of malodor associated with advanced and recurrent breast cancer

Cited by 3 publications

References 2 publications

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)

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)

A patient in whom metronidazole was effective for cancerous malodor related to pleural metastasis, involving the thoracic wall, from gastric cancer

Case Study on Usefulness of Clindamycin-pate in Treatment of Extensive Malodorous Effusion from Malignant Melanoma and Evaluation of Water Absorbability of Ointment Base

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