Garcia, J.M., Friend, J., & Allen, S. (2012). Therapeutic potential of anamorelin, a novel, oral ghrelin mimetic, in patients with cancer-related cachexia: A multicenter, randomized, double-blind, crossover, pilot study. Supportive Care in Cancer, 21, 129–137.

DOI Link

Study Purpose

To evaluate the effects of anamorelin in patients with cancer-related cachexia

Intervention Characteristics/Basic Study Process

Patients received anamorelin 50 mg/day or placebo for a three-day treatment period. This was followed by a seven-day washout period. After the washout, patients were switched to the opposite intervention. Assessments were done at baseline and at the end of each study period. Patients were stratified according to level of weight loss prior to random assignment to the treatment condition sequence.

Sample Characteristics

  • The study reported on 16 patients.
  • Mean patient age was 62 years.
  • The sample was 75% male and 25% female.
  • Patients had various tumor types.
  • Most patients had an Eastern Cooperative Oncology Group performance status of 1.
  • All patients had experienced at least a 5% weight loss in the past six months.

Setting

  • Multisite
  • Inpatient setting 
  • United States

Phase of Care and Clinical Applications

  • Patients were undergoing palliative care.
  • The study has clinical applicability for late effects and survivorship.

Study Design

The study was a double-blind, placebo-controlled, crossover, randomized controlled trial.

Measurement Instruments/Methods

  • Body weight
  • Appetite scored on a 100 mm visual analog scale
  • Anderson Symptom Assessment Scale (ASAS)
  • Edmonton Symptom Assessment Scale
  • Functional Assessment of Chronic Illness Therapy–Fatigue Scale (FACIT-F)
  • Bristol-Myers Anorexia/Cachexia Recovery Instrument
  • Caloric intake

Results

There was no treatment effect on caloric intake. Growth hormone levels were significantly greater when patients received anamorelin compared to placebo (p = 0.005). ASAS total scores improved after three days of anamorelin (p < 0.002). Among individual symptom items, patients reported improved appetite (2.67 points with anamorelin and 0.5 points with placebo, p = 0.011). FACIT-F scores improved after anamorelin  compared to placebo (p = 0.018).

Conclusions

Anamorelin was shown to have some positive effects on patients’ symptoms in this small pilot study. Further research is needed to evaluate efficacy.

Limitations

The study had a small sample size, with less than 30 participants.

Nursing Implications

This study was too small to enable any conclusions about the efficacy and safety of anamorelin. Further research with a larger sample is needed.