Dietary intervention to maintain a consistent rectal volume for patients receiving radical radiotherapy to the prostate: A Randomised Study

Not Applicable

Completed

• Conditions: Prostate Cancer; Cancer - Prostate

• Registration Number: ACTRN12610000122055
• Lead Sponsor: Peter MacCallum Cancer Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02-05
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 30

Inclusion Criteria

Patients 50 years of age or older, eligible for External Beam Radiotherapy (EBRT) for prostate cancer to a dose of at least 74Gy in 37 fractions.
- Biopsy proven adenocarcinoma of the prostate, International Union against Cancer (UICC) TNM Classification of Malignant Tumours 6th edition stages T1-T3b.
- Patients who will successfully received gold seed implants.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria

- Patients receiving radical salvage therapy post-prostatectomy.
- Patients with a history of Irritable Bowel Syndrome (IBS)
- Patients with a history of constipation in the 6 months prior to diagnosis or receiving opiate analgesics.
- Patients with a concurrent or previous malignancy within 5 years prior to randomisation.
- Patients having received prior radiotherapy to the pelvis.
- Patients with dietary or medical requirements that will prevent them following the prescribed diet.
- Patients receiving any other investigational agents that may impact upon this study.
- Patients with other uncontrolled concurrent illnesses, psychiatric illness or social circumstance that may limit compliance with this study.
- Prosthesis that may inhibit the visibility of the seeds – and possibly the prostate on Cone Beam Computed Tomography (CBCT) images.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rectal volume variability as determined by the contoured rectal volume on Cone Beam Computed Tomography aquired at the end of the treatment fractions below.[Treatment fractions 1-5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, 37 (and 39 if receiving 78Gy)]