Ignite Creation Date:
2024-05-06 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 2:23 PM
Study NCT ID:
NCT05216328
Status:
RECRUITING
Last Update Posted:
2023-10-31
First Post:
2022-01-19
Brief Title:
Prevention of Opioid-induced Constipation in Patients With Advanced Cancer
Sponsor:
Amsterdam UMC location VUmc
Organization:
Amsterdam UMC location VUmc
Study Overview
Official Title:
OMAMA-study - Prevention of Opioid-induced Constipation in Patients With Advanced Cancer
Status:
RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OMAMA
Brief Summary:
More than 70 of patients with cancer in the palliative phase have pain that often requires treatment with opioids morphine-like agents Constipation occurs in 59 of patients treated with opioids Opioid-induced constipation OIC has consequences that range from daily discomfort with social insecurity and disability to intestinal obstruction It leads to limitations in self-management a reduced quality of life and a risk of the need for more care In the guideline Diagnosis and treatment of pain in patients with cancer it is recommended to start preventively with an osmotic laxative such as macrogolelectrolytes or magnesium hydroxide when starting opioids Macrogolelectrolytes has been proven to be effective for OIC but is sometimes perceived by patients as unpleasant due to its taste Magnesium hydroxide which is less commonly prescribed for OIC has a neutral taste Although it is mentioned in the guideline it is not studied for the treatment of OIC and also not officially registered for this To support the advice of the guideline and to prove that a choice is possible it is important to investigate whether there are differences in effectiveness andor side effects between macrogolelectrolytes and magnesium hydroxide in the prevention of OIC
The aim of this study is to compare macrogolelectrolytes with magnesium hydroxide in the prevention of opioid-induced constipation in patients with cancer in the palliative incurable phase who start opioids because of pain The choice of laxative is determined by drawing lots randomisation After two weeks its effect will be assessed and will be presented as the percentage of patients who have not developed constipation after starting opioids If the laxative as assigned by lot is described as satisfactory by the patient the patient can continue with the drug that the patient used after the study through regular prescription
The investigators will ask the patients in the study about their satisfaction with the laxative used any side effects and the degree of pain Furthermore the appeal to care for possible constipation will be examined Because the best attainable quality of life in the palliative phase is the objective of all care the investigators will also measure this perceived quality with a questionnaire in this study The results of this study will lead to the best achievable prevention of opioid constipation in patients with cancer in the palliative phase
The aim of this study is to compare macrogolelectrolytes with magnesium hydroxide in the prevention of opioid-induced constipation in patients with cancer in the palliative incurable phase who start opioids because of pain The choice of laxative is determined by drawing lots randomisation After two weeks its effect will be assessed and will be presented as the percentage of patients who have not developed constipation after starting opioids If the laxative as assigned by lot is described as satisfactory by the patient the patient can continue with the drug that the patient used after the study through regular prescription
The investigators will ask the patients in the study about their satisfaction with the laxative used any side effects and the degree of pain Furthermore the appeal to care for possible constipation will be examined Because the best attainable quality of life in the palliative phase is the objective of all care the investigators will also measure this perceived quality with a questionnaire in this study The results of this study will lead to the best achievable prevention of opioid constipation in patients with cancer in the palliative phase
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None