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Chemotherapy-Induced Diarrhea

Chemotherapeutic agents are widely used to destroy tumor cells and prevent cancer progression. Nevertheless, these agents have a very broad spectrum of cytotoxic activity and often cause damage and dysfunction of untargeted organ systems. Chemotherapy-Induced Diarrhea (CID) is a well recognized side effect of a number of chemotherapeutic regimens in cancer patients and can be debilitating and potentially life-threatening.

The incidence and severity of CID varies considerably with the intensity and nature of the cytotoxic therapy. Particularly colorectal cancer patients on 5-FU and irinotecan containing treatment regimens are severely affected by CID and frequencies up to 80% have been reported.

CID can result in severe dehydration, malnutrition, electrolyte imbalances and other instabilities. For the already compromised cancer patients, development of CID may necessitate dose reduction, delays or even discontinuation of the chemotherapy. Ultimately, the cancer patient would be unable to receive optimal treatment for their cancer because of their diarrhea.

Current treatment and unmet need
There is currently no effective treatment for intestinal damage as a result of chemotherapy and therefore no effective therapy for either the prevention or the treatment of associated diarrhea.  This complication is debilitating and often dose-limiting for the cancer therapy.  Treatment is deferred until the intestinal wall has recovered some weeks after the last chemotherapeutic dose.  If the condition is severe, patients are unable to take nourishment by mouth and, as a result, parenteral, or non-alimentary, nutrition may be initiated. 

Current treatment of chemotherapy-induced diarrhea depends on the severity, with the milder cases being treated by diet alone.  As the condition worsens, first-line treatment is opioids, such as loperamide and diphenoxylate.  However, it is not uncommon for patients to be unresponsive to this therapy.  If this is the case, octreotide, a somatostatin analogue (Sandostatin LAR) is given as a depot injection as second line therapy.  In more severe cases the patients will be hospitalized and given intravenous fluids.  Nevertheless, as noted above, some 20% of patients require dose regimes to be changed or stopped as a result of chemotherapy-induced diarrhea.

There is a need for a product which can prevent or treat the diarrhea during chemotherapy to secure optimal treatment with cytotoxic drugs and prevent intestinal complications. 

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