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Trial registered on ANZCTR


Registration number
ACTRN12610000122055
Ethics application status
Approved
Date submitted
3/02/2010
Date registered
5/02/2010
Date last updated
14/11/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Dietary intervention to maintain a consistent rectal volume for patients receiving radical radiotherapy to the prostate: A Randomised Study
Scientific title
Dietary intervention to maintain a consistent rectal volume for patients receiving radical radiotherapy to the prostate: A Randomised Study
Secondary ID [1] 1375 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 256745 0
Condition category
Condition code
Cancer 256899 256899 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Standard radical prostate radiotherapy of 74-78Gy in 37-39 daily fractions (5 times per week) over a period of 8 weeks. Two weeks prior to the treatment planning appointment participants will begin a dietary intervention of an antiflatulent diet and a psyllium supplement. The diet limits foods which are high in complex carbohydrates and supplements those foods with 20g of psyllium husk per day. The total duration of diet intervention will be around 11-12 weeks.
Intervention code [1] 255961 0
Treatment: Other
Comparator / control treatment
Standard radical prostate radiotherapy of 74-78Gy in 37-39 daily fractions (5 times per week) over a period of 8 weeks with no diet intervention.
Control group
Active

Outcomes
Primary outcome [1] 257768 0
Rectal volume variability as determined by the contoured rectal volume on Cone Beam Computed Tomography aquired at the end of the treatment fractions below.
Timepoint [1] 257768 0
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)
Secondary outcome [1] 263165 0
Cone Beam Computed Tomography (CBCT) image quality
Timepoint [1] 263165 0
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)
Secondary outcome [2] 263166 0
Rectal Filling of empty, gas, moving gas and/or faeces as judged by one investigator on Cone Beam Computed Tomography aquired at the end of the treatment fractions below.
Timepoint [2] 263166 0
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)
Secondary outcome [3] 263167 0
Interfraction prostate motion as determined by the location of gold seed fiducial markers within the prostate on kilovoltage imaging taken at the start of treatment fractions.
Timepoint [3] 263167 0
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)
Secondary outcome [4] 263168 0
Intrafraction prostate motion as determined by the position of gold seed fiducial markers within the prostate on Cone Beam Computed Tomography aquired at the end of the treatment fractions below.
Timepoint [4] 263168 0
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)
Secondary outcome [5] 263169 0
Adverse events assessed weekly during participant review using the Common Terminology Criteria for Adverse Events v3.0 (CTCAE). Adverse events to be assessed will be Weight, Fatigue, Constipation/Diarrhoea, Dehydration, Distension, Dysphagia/obstruction, Flatulence, Haemorrhoids, Anal & bladder Incontinence, Nausea/vomiting, Urinary Frequency, Urinary Retention.
Timepoint [5] 263169 0
Weekly during treatment.
Secondary outcome [6] 263170 0
Quality of life using the European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaires QLQ-C30 and QLQ-PR25.
Timepoint [6] 263170 0
Baseline, treatment week 4, treatment week 8, 6 weeks post treatment, 6 months post treatment.

Eligibility
Key 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.
Minimum age
50 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
- The screening log will be maintained by the Principal Investigator (PI), Eligible patients will be logged on the screening log and flagged for the Radiation Oncologist (RO) to approach for study during clinic consultation.
- Interested patients will have an appointment made to see the PI or Dietitian for detailed information provision and consent procedures to take place. Patients will have the option of taking the patient information and consent form (PICF) away to consider the study with family and friends. A follow up appointment will be made in this case to allow the patient to sign the consent form.
- When informed consent is obtained by the investigators the patient will be randomised via the telephone randomisation process. The PI will telephone the university supervisor who will provide information on the participant’s randomisation arm. The randomisation will be a computer-generated varied-size block randomisation. Only the university supervisor will know block size and block sequence.
- At this time the participant will be provided with a study pack containing the diet diary and information sheets relevant to their arm.
- The PI will maintain an enrolment log of patients successfully entered to the study, their unique identifier used for anonymity of data records and their randomisation arm.
- Study investigators and prescribing ROs will be notified by email when a patient is recruited, the email will include the patient name and their hospital UR number, as well as the study recruitment total. Investigators and ROs will be asked not to keep a log of recruitment arm to minimise selection bias towards the end of the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be a computer-generated varied-size block randomisation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Investigators doing the patient contouring are blinded to study arm.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/02/2010
Actual
3/02/2010
Date of last participant enrolment
Anticipated
Actual
15/06/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 2524 0
3444
Recruitment postcode(s) [2] 2526 0
3450
Recruitment postcode(s) [3] 2525 0
3451
Recruitment postcode(s) [4] 2527 0
3462
Recruitment postcode(s) [5] 2528 0
3463
Recruitment postcode(s) [6] 2529 0
3464
Recruitment postcode(s) [7] 2530 0
3465
Recruitment postcode(s) [8] 2531 0
3472
Recruitment postcode(s) [9] 2532 0
3496
Recruitment postcode(s) [10] 2533 0
3500
Recruitment postcode(s) [11] 2522 0
3550
Recruitment postcode(s) [12] 2523 0
3551
Recruitment postcode(s) [13] 2537 0
3557
Recruitment postcode(s) [14] 2538 0
3558
Recruitment postcode(s) [15] 2539 0
3559
Recruitment postcode(s) [16] 2540 0
3561
Recruitment postcode(s) [17] 2536 0
3564
Recruitment postcode(s) [18] 2541 0
3570
Recruitment postcode(s) [19] 2535 0
3579
Recruitment postcode(s) [20] 2534 0
3580
Recruitment postcode(s) [21] 2542 0
3585
Recruitment postcode(s) [22] 2543 0
3630

Funding & Sponsors
Funding source category [1] 256462 0
Hospital
Name [1] 256462 0
Peter MacCallum Cancer Centre
Country [1] 256462 0
Australia
Primary sponsor type
Hospital
Name
Peter MacCallum Cancer Centre
Address
PO Box 126
Bendigo VIC
3552
Country
Australia
Secondary sponsor category [1] 255771 0
None
Name [1] 255771 0
Address [1] 255771 0
Country [1] 255771 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258515 0
Peter MacCallum Cancer Centre Ethics Committee
Ethics committee address [1] 258515 0
Locked Bag 1 A'Beckett St
Victoria 8006
Ethics committee country [1] 258515 0
Australia
Date submitted for ethics approval [1] 258515 0
Approval date [1] 258515 0
18/01/2010
Ethics approval number [1] 258515 0
09/60

Summary
Brief summary
Prostate cancer is the most commonly diagnosed cancer in Australia, making up 16% of all diagnosed cancers (excluding skin cancers). Fortunately, survival in prostate cancer is relatively good, with 84-88% of men living at least five years after diagnosis. Many men who are diagnosed with prostate cancer choose radical external beam radiation therapy (EBRT) for their treatment. EBRT is a radiation treatment usually given by one treatment per weekday over eight weeks. This treatment method offers very good treatment outcomes for controlling prostate cancer, however, it can produce some unwanted side effects. As most men who have EBRT live for at least 10-15 years after diagnosis, minimising these side effects is very important to offer the best quality of life to survivors.

Diet invervention is a novel approach to solving one of the biggest challenges in prostate radiotherapy. The prostate gland constantly moves within the patient during radiotherapy because of its position close to the rectum. Changes in rectal filling is identified as the main cause of prostate movement. This movement means a larger volume must be treated to ensure all parts of the prostate receive enough radiation dose to cure the patient. Unfortunately treating a bigger area means healthy tissues next to the prostate such as the rectum and bladder also receive radiation dose. Irradiation of these organs is responsible for the sometimes debilitating side effects associated with radiotherapy. Short term side effects of treatment can include frequent and painful urination, diarrhoea and rectal discomfort. Long term side effects may include frequent, urgent and loose bowel motions, rectal bleeding and some may suffer from urinary incontinence. To reduce dose to these organs and to improve the dose delivery to the prostate they need to be kept stable during treatment. The aim of our study is to test the activity of a diet which is designed to keep the organ positions more consistent to see if it will reduce rectal variation. This has the advantage of empowering patients to be actively involved in their treatment. The study will utilise cone beam computed tomography (CBCT) scanning to assess prostate movement and rectal filling.

This study will include 30 participants over 12 months who will be randomly assigned to either study arm. The study will change the diet of 15 patients receiving radiotherapy over the full course of their planning and treatment (about 11 weeks). To make a comparison we include 15 patients on the normal treatment arm who will eat their usual diet. All participants will record a diet diary so we can make sure the diet intervention arm follow their diet and also see what foods are being eaten in the normal diet which may produce bowel gas. CBCT scans will be taken on days 1 to 5 and then every second day for all participants. In this study we will assess if we can obtain reliable information about the rectum and prostate positions and their shape on all CBCT scans. We will then measure the difference of the organ positions between the diet intervention arm and the normal treatment arm and use this information to determine the sample size of a larger follow on study. We will also compare side effects and quality of life between the two study arms to see if there are any unexpected impacts associated with the diet intervention.

If successful this study will follow on to a bigger study to see if the diet change is really better at keeping the prostate stable than eating a normal diet. The potential outcome for the studies will be a cheap, non-invasive method of reducing prostate movement during EBRT. This could improve the control of prostate cancer with EBRT and also reduce side-effects from the treatment. There is potential to further reduce the area treated to spare even more of the healthy tissue from radiation dose. The overall outcome would be to offer better quality of life to patients with prostate cancer who are treated with EBRT.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30799 0
Mr Richard Oates
Address 30799 0
Peter MacCallum Cancer Centre
PO Box 126 Bendigo VIC 3552
Country 30799 0
Australia
Phone 30799 0
+61 3 54549234
Fax 30799 0
Email 30799 0
richard.oates@petermac.org
Contact person for public queries
Name 14046 0
Mr Richard Oates
Address 14046 0
PO Box 126
Bendigo VIC
3552
Country 14046 0
Australia
Phone 14046 0
+61 3 5454 9234
Fax 14046 0
Email 14046 0
richard.oates@petermac.org
Contact person for scientific queries
Name 4974 0
Mr Richard Oates
Address 4974 0
PO Box 126
Bendigo VIC
3552
Country 4974 0
Australia
Phone 4974 0
+61 3 5454 9234
Fax 4974 0
Email 4974 0
richard.oates@petermac.org

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