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Building the evidence for clinical practice: ROMANA trials (part 2)
Questions and Answers with Dr. Kenneth Fearon, recorded at the Int. SCWD Conference on Cachexia on 05 December 2015
ROMANA 1 and 2 were parallel, international, phase 3 randomized clinical studies performed to evaluate the effect of anamorelin treatment on the symptoms of cancer cachexia in patients with stage III or IV non-small cell lung cancer. Anamorelin treatment resulted in significantly increased lean body mass and improvement in quality of life measures and was generally well tolerated.
In this question and answer session, Dr. Kenneth Fearon (Edinburgh, Scotland) questioned whether hand grip strength is an appropriate functional index in this patient population and suggests that another measure be used in future trials. In addition, he indicated that he would focus on increasing dietary protein intake and instituting an exercise program in future studies. Further, assessing improvements in physical activity as a whole might be more meaningful to assess rather than strength of an individual muscle to determine the functional impact of treatment. However, Dr. Fearon stressed that there are variations in physical activity between individuals, and patients receiving chemotherapy may be at different levels based on their treatment cycle.
Dr. Fearon indicated that there is no current standard of care for cancer cachexia, though it is evident that patients require proper nutrition and exercise. There is debate on whether randomizing patients to nutrition and exercise interventions would be appropriate in a clinical trial setting.
Dr. Fearon concluded with a comment on the correlation between muscle mass and muscle strength. In healthy young people, muscle mass and function is closely correlated, but this relationship is variable in frail, elderly individuals as in the populations of ROMANA 1 and 2.
This video has been recorded at the 8th Int. Conference on Cachexia, Sarcopenia and Muscle Wasting on the 5th of December 2015 in Paris, France.
The symposium on Cachexia at the Int. SCWD Conference 2015 was sponsored by Helsinn SA.