It is hypothesized that using methylnaltrexone in addition to pain killer narcotics (opiates) in patients will result in increased tube feeding rates with more frequent nutrition at goal calorie rate.
Tube feeding rates and tube feeding residual volumes will be measured and followed blinded to the treatment arm (methylnaltrexone vs. placebo) to evaluate if patients (who prior to study entry did not tolerate goal rates tube feeds) can get closer to tube feeding goal with the treatment arm.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Methylnaltrexone 8 mg IV for subjects 38 to 62 kg body weight, Methylnaltrexone12 mg IV for subjects 62.1 to 114 kg body weight
Saline 0.4 to 0.8 ml injection
Hahnemann University Hospital
Philadelphia, Pennsylvania, United States
Cancer Treatment Center of America
Philadelphia, Pennsylvania, United States
Hydrogen breath test measure of bowel transit
On day 1 Hydrogen Breath Test (HBT) measures will occur 30 minutes before test meal, immediately after test meal every 15 minutes until a rise of 5ppm is detected or until 4 hours have passed. On day 2 Hydrogen Breath test measures will occur 30 minutes before test meal, immediately after test meal and every 15 minutes until a rise of 5ppm is detected or until 4 hours have passed.
Time frame: 2 days
Gastric residual volume measurement
Gastric residual volumes will be measured at baseline study entry and then every 4 hours throughout the study until 24 hours post study drug administration.
Time frame: 3 days
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