|- candidate number||2957|
|- NTR Number||NTR1161|
|- ISRCTN||Wordt niet aangevraagd (NVT)|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||18-dec-2007|
|- Secondary IDs||20599 N/A|
|- Public Title||Magnesium oxide to reduce prostate motion.|
|- Scientific Title||Double-blind placebo-controlled randomized study to determine the effectiveness of magnesium oxide to reduce the prostate motion. |
|- ACRONYM||Magnesium oxide to reduce prostate motion|
|- hypothesis||The hypothesis is that magnesium oxide is effective in reducing the intrafraction motion of the prostate during radiotherapy treatment for prostate cancer. |
|- Healt Condition(s) or Problem(s) studied||Prostate cancer, Prostatic neoplasms|
|- Inclusion criteria||Prostate cancer patients scheduled for external beam radiotherapy using fiducial marker-based position verification.
|- Exclusion criteria||1. Patients with known severe constipation;|
2. Patients who receive laxatives;
3. Patients with a history of abdominal surgery;
4. Patients with known abdominal diseases (M. Crohn, colitis ulcerosa, diverticulitis);
5. Patients with known severe renal failure;
6. Patients who receive tetracyclines, digoxine, iron or ciprofloxacine;
7. Patients with known kidney stones.
|- mec approval received||no|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-apr-2008|
|- planned closingdate||1-mei-2009|
|- Target number of participants||184|
|- Interventions||One group receives a capsule of 500mg magnesium oxide twice a day and the other group receives a placebo capsule twice a day during the radiotherapy treatment.|
|- Primary outcome||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 movement of the prostate. |
|- Secondary outcome||Toxicity will be measured by the Common Toxicity Criteria (CTC) version 3.0 (Trotti). The physician in attendance will score the complaints before treatment and acute toxicity will be scored weekly during the treatment and four weeks after the treatment. All symptoms will be registered even if they occur only on one single occasion. |
The Quality of Life (QoL) before treatment and after the treatment will be measured by RAND-36 (general health), EORTC QLQ-C30 (+3) (cancer specific) and the EORTC QLQ-PR25 (prostate specific) (Hornbrook, Aaronson, Borghede). The first QoL questionnaire will be hand over to the patient at the department and the second questionnaire will be sent to the patient.
The amount of gas will be counted by delineation of the gas pockets on the CT-scan and MR-scan before the treatment.
|- Timepoints||Before radiotherapy, during the 7 weeks radiotherapy treatment and 4 weeks after radiotherapy.|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||dr. I.M. Lips (M.D.)|
|- CONTACT for SCIENTIFIC QUERIES||dr. M. van Vulpen (M.D.)|
|- Sponsor/Initiator ||University Medical Center Utrecht (UMCU)|
(Source(s) of Monetary or Material Support)
|University Medical Center Utrecht (UMCU)|
|- Brief summary||Rationale:|
Some institutes use magnesium oxide to reduce the movement of the prostate during radiotherapy treatment, however this treatment is not evidence based. The hypothesis is that magnesium oxide is effective in reducing the intrafraction motion of the prostate during radiotherapy treatment for prostate cancer.
Main: reduced intrafraction motion.
1. changed toxicity;
2. change quality of life;
3. reduced gas inside the rectum.
Double-blind placebo-controlled randomized intervention study.
Prostate cancer patients who are being treated with external beam radiotherapy using fiducial marker-based position verification.
One group receives a capsule of 500mg magnesium oxide twice a day and the other group receives a placebo capsule twice a day during the radiotherapy treatment.
Main study parameters:
Reducing the intrafraction motion of the prostate with 30%.
|- Main changes (audit trail)|
|- RECORD||18-dec-2007 - 9-apr-2008|