MAGNESIUM HYDROXIDE for Advanced cancer

Inclusion criteria

• {"criterion_text":"- In order to be eligible to participate in this study, a subject must meet all of the following criteria: Patients with advanced cancer (≥18 years);\n- Starting with slow release or transdermal opioids for pain;\n- Able to complete a Dutch questionnaire."}

Exclusion criteria

• {"criterion_text":"- A potential subject who meets any of the following criteria will be excluded from participation in this study: Patients with contra-indications for laxatives;\n- Maintenance treatment with laxatives during the last two weeks\n- Severely impaired renal function (serum creatinine >180 umol/l);\n- Diarrhea at the start of the study, defined as the passage of three or more loose or liquid stools per day (or more frequent passage than is normal for the individual).\n- Life expectancy < 1 month"}

Primary endpoints

• {"endpoint_text":"- The primary endpoint is constipation, defined as the percentage of patients with a score of <30 of the Bowel Function Index, measured on day 14.","definition_or_measurement_approach":"Constipation defined as percentage of patients with a Bowel Function Index (BFI) score <30, measured on day 14."}

Secondary endpoints

• {"endpoint_text":"- Change of the Bowel Function Index Score between day 0 and day 14;","definition_or_measurement_approach":"Change in BFI score measured between day 0 and day 14."}
• {"endpoint_text":"- Quality of life;","definition_or_measurement_approach":"Quality of life measured (secondary objectives specify measurement with the EQ-5D)."}
• {"endpoint_text":"- Rome IV criteria for opioid-induced constipation as judged by professional care givers;","definition_or_measurement_approach":"Assessment of Rome IV criteria for OIC as judged by professional caregivers."}
• {"endpoint_text":"- Cancer pain score;","definition_or_measurement_approach":"Pain score related to cancer as recorded per study assessments (no specific instrument stated in endpoint listing)."}
• {"endpoint_text":"- Side effects of laxatives;","definition_or_measurement_approach":"Recording and comparison of laxative-related adverse events (no further measurement detail in endpoint listing)."}
• {"endpoint_text":"- Cost-effectiveness of macrogol/electrolytes compared to magnesium hydroxide;","definition_or_measurement_approach":"Comparative cost-effectiveness analysis between macrogol/electrolytes and magnesium hydroxide (no further detail in endpoint listing)."}
• {"endpoint_text":"- Patient satisfaction with laxative.","definition_or_measurement_approach":"Patient-reported satisfaction with laxative treatment (measurement instrument not specified in endpoint listing)."}

Methods

• Website recruitment material (document: 'K2_recruitment material website wwwomamastudienl') — digital outreach targeting patients with advanced cancer in the Netherlands.
• Information letters and patient-facing materials (documents: 'K2_recruitment material information letter OMAMA studie', patient-facing questionnaires and diaries) distributed to potential participants at participating sites.
• Recruitment procedure document ('K1_Recruitment procedure' / 'K_Recruitment Procedure tracked changes') describing site-level recruitment process at participating hospitals in the Netherlands.

Netherlands

Earliest CTIS Part Ii Submission Date

16-10-2024

Latest Decision Or Authorization Date

19-03-2025

Processing Time Days

154

Number Of Sites

16

Number Of Participants

250

Primary sponsor

Full Name

Amsterdam UMC

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands