Magnesium oxide to reduce prostate motion.

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON24191

Enrollment

184

Registered

2007-12-18

Start date

2008-04-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

1. Prostate cancer

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.

Eligibility

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Contacts

Public ContactI.M. Lips (M.D.)

Postbus 85500 University Medical Center Utrecht (UMC) Department of Radiatherapy

i.m.lips@umcutrecht.nl+31 (0)88 755 8800

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)