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

Phase 3

Completed

Conditions: prostate cancer
prostate carcinoma
10038597

Registration Number: NL-OMON31671

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 92

Inclusion Criteria

Prostate cancer patients scheduled for external beam radiotherapy using fiducial marker-based position verification.

Exclusion Criteria

-Patients with known severe constipation
-Patients who receive laxatives
-Patients with a history of abdominal surgery
-Patients with known abdominal diseases (M. Crohn, colitis ulcerosa, diverticulitis )
-Patients with known severe renal failure or creatinine clearance of < 50 ml/min/1.73 m2
-Patients who receive tetracyclines, digoxine, iron or ciprofloxacine and the intake of this medication must be at the same time as the study medication
-Patients with known kidney stones
-Patients with known heart block

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary study parameter is the movement of the prostate during a fraction<br /><br>of radiotherapy. The three fiducial markers are being imaged 5 times during one<br /><br>fraction. These 5 images can be used to derive the range of the intrafraction<br /><br>position of the prostate. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Toxicity will be measured by the Common Toxicity Criteria (CTC) version 3.0.<br /><br>The physician in attendance will score the complaints before treatment and<br /><br>acute toxicity will be scored weekly during the treatment and four weeks after<br /><br>the treatment.<br /><br><br /><br>The Quality of Life (QoL) before treatment and after the treatment will be<br /><br>measured by RAND-36 (general health), EORTC QLQ-C30 (+3) (cancer specific) and<br /><br>the EORTC QLQ-PR25 (prostate specific). The first QoL questionnaire will be<br /><br>hand over to the patient at the department and the second questionnaire will be<br /><br>sent to the patient 4 weeks after the treatment.<br /><br><br /><br>The amount of gas will be determined by delineation of the gas pockets on the<br /><br>CT-scan and MR-scan before the treatment.</p><br>