Double-blind placebo-controlled randomized study to determine the effectiveness of magnesium oxide to reduce the prostate motion. - Magnesium oxide to reduce prostate motio

Conditions: Prostate cancer patients who are being treated with external beam radiotherapy using fiducial marker-based position verification.
MedDRA version: 9.1Level: LLTClassification code 10060862Term: Prostate cancer

Registration Number: EUCTR2007-007072-42-NL

Lead Sponsor: niversity Medical Center Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Male

Target Recruitment: Not specified

Inclusion Criteria

Prostate cancer patients scheduled for external beam radiotherapy using fiducial marker-based position verification
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Patients with known severe constipation
- Patients who receive laxantia
-Patients with a history of abdominal surgery
-Patients with known abdominal diseases (M. Crohn, colitis ulcerosa, diverticulitis )
-Patients with known severe renal failure
-Patients who receive tetracyclines, digoxine, iron or ciprofloxacine.
-Patients with known kidney stones

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Does the use of daily magnesium oxide reduce the prostate movements during a radiotherapy fraction? <br>;Secondary Objective: Does the use of magnesium oxide change the acute toxicity of the treatment?<br><br>Does the use of magnesium oxide change the quality of life?<br><br>Does the use of magnesium oxide reduce the amount of gas inside the rectum?<br><br>;Primary end point(s): The main study parameter is the movement of the prostate during a fraction of radiotherapy. The three fiducial markers are being imaged 5 times during one fraction. These 5 images can be used to derive the range of the intrafraction position of the prostate .

Secondary Outcome Measures