Chasen, M., Hirschman, S.Z., & Bhargava, R. (2011). Phase II study of the novel peptide-nucleic acid OHR118 in the management of cancer-related anorexia/cachexia. Journal of the American Medical Directors Association, 12, 62–67.
To determine the effect of OHR118 on appetite, early satiety, and nutritional intake in patients with advanced cancer experiencing anorexia or anorexia-cachexia syndrome
Patients received 4.0 ml of OHR118 via subcutaneous injection daily for 28 days. Patients who benefited were offered the option to continue for a total of 56 days.
Eleven patients completed the first 28 days of the study, and 6 completed the second 28 days. Results from the first 28 days demonstrated a statistically significant improvement of appetite (p = 0.01) and depression (p = 0.05) on the ESAS. All other ESAS items did not show a statistically significant improvement. The overall PG-SGA score measuring nutrition (weight loss, nutrition impact symptoms, intake, and functional capacity) was significantly reduced (p = 0.01). The DSSI showed statistically significant results for the items of frequent burping or belching (p = 0.02), feeling full after meals (p = 0.04), and abdominal distention (p = 0.03). The sit-to-stand item on the SFA was statistically significant (p = 0.01) for deterioration of ability.
The authors concluded that OHR118 showed improvements consistent with previous work done in a \"very positive\" larger study in the AIDS population, and that this translates to \"improved patient comfort and quality of life.\"
Of the many values measured with the multiple measurement tools, only the general PG-SGA score, appetite, frequent belching, feeling full after meals, and abdominal distention showed statistically significant improvement. The study did not meet the secondary endpoints of changes in performance status, lean muscle mass, or quality of life.
This study should be interpreted with caution because it was small, with limited statistically significant results to support the research objective.