Primairy objective: Does the use of daily magnesium oxide reduce the prostate movements during a radiotherapy fraction? Secondary objectives: Does the use of magnesium oxide change the acute toxicity of the treatment? Does the use of magnesium oxide…
ID
Source
Brief title
Condition
- Reproductive neoplasms male malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary 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
Toxicity will be measured by the Common Toxicity Criteria (CTC) version 3.0.
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.
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). The first QoL questionnaire will be
hand over to the patient at the department and the second questionnaire will be
sent to the patient 4 weeks after the treatment.
The amount of gas will be determined by delineation of the gas pockets on the
CT-scan and MR-scan before the treatment.
Background summary
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.
Study objective
Primairy objective: Does the use of daily magnesium oxide reduce the
prostate movements during a radiotherapy fraction?
Secondary objectives: Does the use of magnesium oxide change the acute toxicity
of the treatment?
Does the use of magnesium oxide change the
quality of life?
Does the use of magnesium oxide reduce the
amount of gas inside the rectum?
Study design
Double-blind placebo-controlled randomized intervention study
Intervention
One group receives two capsules of 250mg magnesium oxide twice a day and the
other group receives two placebo capsules twice a day during the radiotherapy
treatment.
Study burden and risks
Patients should take twice a day a capsule during the radiotherapy treatment
and have to fill in a quality of life questionnaire before and after the
radiotherapy treatment and.
The risk associated with the intake of magnesium oxide is physical discomfort
consisting of diarrhoea.
Patient will undergo one venous puncture.
Heidelberglaan 100
3584 CX
Nederland
Heidelberglaan 100
3584 CX
Nederland
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2007-007072-42-NL |
| CCMO | NL20599.041.08 |