The hypothesis is that magnesium oxide is effective in reducing the intrafraction motion of the prostate during radiotherapy treatment for prostate cancer.
ID
Bron
Verkorte titel
Aandoening
1. Prostate cancer;
2. radiotherapy.
(NLD: prostaatkanker, bestraling).
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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.
Achtergrond van het onderzoek
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.
Objective:
Main: reduced intrafraction motion.
Secondary:
1. changed toxicity;
2. change quality of life;
3. reduced gas inside the rectum.
Study design:
Double-blind placebo-controlled randomized intervention study.
Study population:
Prostate cancer patients who are being treated with external beam radiotherapy using fiducial marker-based position verification.
Intervention:
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%.
Doel van het onderzoek
The hypothesis is that magnesium oxide is effective in reducing the intrafraction motion of the prostate during radiotherapy treatment for prostate cancer.
Onderzoeksopzet
Before radiotherapy, during the 7 weeks radiotherapy treatment and 4 weeks after radiotherapy.
Onderzoeksproduct en/of interventie
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.
Publiek
University Medical Center Utrecht (UMC)
Department of Radiatherapy
I.M. Lips (M.D.)
Utrecht 3508
The Netherlands
+31 (0)88 755 8800
i.m.lips@umcutrecht.nl
Wetenschappelijk
University Medical Center Utrecht (UMC)
Department of Radiatherapy
I.M. Lips (M.D.)
Utrecht 3508
The Netherlands
+31 (0)88 755 8800
i.m.lips@umcutrecht.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Prostate cancer patients scheduled for external beam radiotherapy using fiducial marker-based position verification.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL1126 |
| NTR-old | NTR1161 |
| Ander register | N/A : 20599 |
| ISRCTN | Wordt niet aangevraagd (NVT) |