Methylnaltrexone for the treatment of opioid-induced constipation in the setting of palliative or hospice care, is significantly more effective than placebo (1). However, in both the randomized and the open-label phase of the multi center trial showing this favorable outcome, the drug produced rescue-free laxation in only about half of the patients (2). There may be several reasons for this result, since constipation in palliative care patients often has multiple simultaneously occurring causes. Assuming that constipation of the non-responders is still opioid-induced, one of the possible reasons for not responding to methylnaltrexone could be that central actions of opioids contribute to constipation by reducing motility of the intestines through direct actions in the spinal dorsal horn (2). However, as methylnaltrexone is a µ-receptor antagonist and not all opioids are solely µ-receptor agonists another reason may well be that successful laxation is determined by the receptor-profile of the specific opioid the patient is using. Opioids do not only influence bowel functioning, but also immune system functioning and angiogenesis. Methylnaltrexone possibly antagonizes these changes, therefore this study will also investigate the influence of methylnaltrexone on immunologic and angiogenic parameters.
Study Type
OBSERVATIONAL
Enrollment
7
Patients will be treated with methylnaltrexone in a standard dosing regimen for their weight: 38-62kg:8 mg, 62-114kg:12 mg, \>114 kg: 0.15 mg/kg) Methylnaltrexone will be administered subcutaneously every other day for up to 7 doses.
Medical Center Alkmaar
Alkmaar, Netherlands
VU University Medical Center
Amsterdam, Netherlands
Hospice Demeter
De Bilt, Netherlands
Hospice Bardo
Hoofddorp, Netherlands
Spaarne Ziekehuis
Hoofddorp, Netherlands
University Medical Center Utrecht
Utrecht, Netherlands
Rescue-free laxation response
The proportion of subjects that has a rescue-free laxation response within 4 hours after at least 2 of the first 4 doses (the first week of treatment).
Time frame: Within 4 hours after at least 2 of the first 4 doses (the first week of treatment).
Time to first laxation
Time to first laxation after initiation of treatment
Time frame: Between dosing and day 14
Number of laxations
* Number of laxations per week * Change in BFI score between day 0 and 14
Time frame: Between dosing and day 14
Laxation within 4 hours
Presence of laxation within four hours after initiation of treatment
Time frame: Between dosing and day 14
laxation within 4 hours after each dose
Number of doses after which laxation occured within four hours after treatment administration
Time frame: Between dosing and day 14
laxation within 24 hours after each dose
Number of doses after which laxation occured within 24 hours after treatment administration
Time frame: Between dosing and day 14
laxation within 4 hours after 4 out of 7 doses
Did laxation occur within 4 hours after at least 4 out of 7 treatment administrations?
Time frame: Between dosing and day 14
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.