The effect of amino acid-oral rehydration solution (Enterade®) on chemotherapy related diarrhea and quality of life in solid tumor cancer patients: A non-randomized experimental study

Purpose: The purpose of this study was to evaluate use of a proprietary amino acid-oral rehydration solution (AA-ORS) known as Enterade® to reduce the severity of chemotherapy related diarrhea (CRD), to improve patient reported Quality of Life (QOL), and to reduce treatment holds, delays, dose modifications, prevention of weight loss, and subjective improvement of associated gastrointestinal mucositis physical symptoms.

Methods: An experimental pilot study without randomization in a single population with two separate measurements over time was performed in a National Cancer Institute (NCI) designated cancer center in the South-Central United States. The variables included sociodemographic data, cancer diagnosis, chemotherapy treatment regimens, Common Terminology Criteria for Adverse Events (CTCAE) v5.0 grade of diarrhea, stool consistency using the Bristol Stool Scale, use of antidiarrheals, associated gastrointestinal mucositis symptoms affecting QOL, and QOL measured with the Functional Assessment of Chronic Illness Therapy-Diarrhea survey.

Results: A total of 22 participants enrolled in the study. Sixteen completed both the pre-survey and post survey. A statistically significant difference was not found between the patient's subjective report of quality of life when comparing pre and post survey responses. There was a statistically significant improvement from baseline in the QOL questions specific to bowel concerns due to diarrhea with a mean pre-survey response score of 35.3 versus a post survey score of 29.2 (p = .003). There was a reduction in the CTCACE grade of diarrhea demonstrating a reduction in the frequency of stools per day (p = .001) and a change in the consistency of stools moving from watery to more formed stools using the Bristol Stool Scale (p = .049).

Conclusion: Use of AA-ORS in this study was found to be useful in the reduction of CRD in patients receiving systemic oncology therapies. This study needs to be replicated with a larger, more inclusive sample size to further support the use of AA-ORS in the reduction of CRD and QOL.