Coyle, V.M., Lungulescu, D., Toganel, C., Niculescu, A., Pop, S., Ciuleanu, T., … Wilson, R.H. (2013). A randomised double-blind placebo-controlled phase II study of AGI004 for control of chemotherapy-induced diarrhoea. British Journal of Cancer, 108, 1027–1033.doi:10.1038/bjc.2013.35
To examine the effectiveness of the use of a controlled-release transdermal patch preparation of mecamylamine (AG1004)
Patients who had received at least one cycle of chemotherapy and experienced grade 1 or 2 diarrhea were randomized to receive transdermal mecamylamine (AG1004) 4 mg every 24 hours or placebo using an identical-looking patch. The patch was applied 24 hours prior to chemotherapy and reapplied daily for the duration of the treatment cycle. Patients were allowed to use loperamide, codeine phosphate, or octreotide on a rescue basis for any active episodes of diarrhea. During the next cycle, the AG1004 dose was increased to 8 mg per day. Evaluation was done at the end of the first day of each cycle and at the end of the overall cycle of chemotherapy. Daily logs were used to record bowel movements and use of rescue medication.
This was a multisite, outpatient study conducted in the United Kingdom and Romania.
This was a double-blind, randomized, placebo-controlled study.
AG1004 was associated with less diarrhea compared to placebo on day one of chemotherapy cycles and did not appear to have significant adverse effects. AG1004 may be helpful in preventing chemotherapy-induced diarrhea.
The sample size was small with fewer than 100 participants.
This study demonstrated some promising results, suggesting that treatment with AG1004 may be useful in preventing chemotherapy-induced diarrhea in patients being treated for cancer with agents known to be associated with diarrhea. Further research is warranted to confirm these findings.