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.

• The study reported on a sample of 11 patients with cancer experiencing anorexia or anorexia-cachexia syndrome.
• Mean patient age was 63 years, with a range of 18–80 years.
• The sample was 71% male and 29% female.
• Patients were diagnosed with lung, pancreatic, colorectal, gastric, prostate, or head and neck cancer.
• Of the sample, 27% of patients had stage III disease and 73% had stage IV disease.

• The study site was not specified, but the authors were from the Division of Palliative Care at the University of Ottawa, so it appears that the study was Canadian and done at a single site.
• The nature of the intervention would suggest an outpatient setting.

• Patients were undergoing the active treatment, end-of-life, or long-term follow-up phase of care.
• The study has clinical applicability for late effects and survivorship, and end-of-life and palliative care.

• A prospective, observational study design was used.
• Patients were not randomized, nor was there a control group.
• Neither patients nor researchers were blinded.

• Patient-Generated Subjective Global Assessment (PG-SGA)
• Edmonton Symptom Assessment Scale (ESAS)
• Dyspepsia Symptom Severity Index (DSSI)
• Simmonds Functional Assessment (SFA)
• Bodystat 1500 (lean body mass and body composition measurement)
• Harpenden Skinfold Caliper (skinfold thickness measurement)

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.

• The authors concluded that the depression item on the ESAS was significant with a p value of 0.05; however, their preanalysis value of significance had been determined to be less than 0.05. They then went on to state in their discussion that improving appetite would improve depression, which their study demonstrated. The significant findings of decreased depression were challenging to interpret because of the statistical methods used in analysis and should be interpreted with caution.
• Of the initial 21 patients recruited, 10 dropped out, 5 had disease progression or died, 2 had abdominal pain, 1 had a phobia of needles, and 2 refused to continue citing no reason. There was no control group, and it is not clear from the study how patients were recruited.
• The abstract states that eight patients continued to 56 days; however, the manuscript analysis says that six completed the 56 days.
• It is not clear if OHR118 is an approved agent.

This study should be interpreted with caution because it was small, with limited statistically significant results to support the research objective.