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The randomized controlled trial of the efficacy of goshajinkigan and lafutidine after mecobalamin administered in breast cancer patients with chemotherapy-induced peripheral neuropathy.

Basic Information

Recruitment status	Complete: follow-up complete
Health condition(s) or Problem(s) studied	chemotherapy-induced peripheral neuropathy
Date of first enrollment	2013/03/01
Target sample size	35
Countries of recruitment	Japan
Study type	Interventional
Intervention(s)	Lafutidine is administered orally at the dose of 10 mg twice daily for 8 weeks. Goshajinkigan is administered orally at the dose of 2.5g three times daily for 8 weeks.

Outcome(s)

Primary Outcome	The level of improvement of peripheral neuropathy is evaluated by Visual Analogue Scale (VAS).
Secondary Outcome	Safety

Key inclusion & exclusion criteria

Age minimum	20years-old
Age maximum	Not applicable
Gender	Female
Include criteria	1)Breast cancer patient with taxane-induced peripheral neuropathy, which continued more than 1 month after chemotherapy with taxane (paclitaxel, nab-paclitaxel, docetaxel). 2)with residual peripheral neuropathy in spite of mecobalamin administered 3)with digestive symptom such as upper abdominal discomfort 4)written informed consent
Exclude criteria	1)not mecobalamin administered 2)with severe complications (such as liver failure, renal failure, heart failure) 3)with history of allergy 4)alredy adminstered with Goshajinkigan, Mecobalamin or Lafutidine. 5)with peripheral neuropathy for other cause (such as diabetes) 6)receiving drugs to influence peripheral neuropathy 7)doctore's decision not to be registered to this study