None listed
Conditions
Brief summary
The purpose of this study is to investigate whether Metamucil and a probiotic (good bowel bacteria) is more effective than Movicol at emptying the bowel while receiving daily radiation therapy to the prostate. Who is this for? You may be eligible for this study if you are aged 50 years or more and have been scheduled to undergo external bean radiotherapy (EBRT) to the intact prostate at the Central West Cancer Care Centre at the Orange Health Service. Study details: Participants will be randomly assigned (by chance) into one of two groups. One group will be prescribed Movicol half strength and a low gas diet (current practice at the treatment facility). The second group will be prescribed Metamucil, Nutralife Probiotic (to promote good bowel bacteria and reduce bowel gas) and a low gas diet. Standard EBRT treatment for prostate cancer is delivered daily (Monday- Friday) over a 7 week period. Laxatives and probiotic use will commence 1 week prior to attending for the radiation planning appointment, then ceased and recommence one week prior to commencing radiation treatment. You will be required to take the laxatives and probiotic daily during the treatment period. In taking part in this study you will also be required to complete of a food and bowel habits diary and attend weekly review appointment with the Dietitian in addition to your usual review appointments with the Doctor or Nurse. It is hoped that results from this study will identify the most effective way to ensure an empty bowel while receiving treatment.
Interventions
Randomised trial comparing the effectiveness of two types of laxation regimens in their ability to achieve an empty rectum during prostate radiation therapy.
Group 1 will be prescribed 1 sachet Movicol Half (Macrogol 3350 6.563g) per day to be consumed orally in the evening. Prescription is as follows
- Use of Movicol half strength is commenced 7 days prior to attending for CT simulation. Once CT simulation is completed use of Movicol half strength is then ceased.
- Use of Movicol Half strength
Randomised trial comparing the effectiveness of two types of laxation regimens in their ability to achieve an empty rectum during prostate radiation therapy. Group 1 will be prescribed 1 sachet Movicol Half (Macrogol 3350 6.563g) per day to be consumed orally in the evening. Prescription is as follows - Use of Movicol half strength is commenced 7 days prior to attending for CT simulation. Once CT simulation is completed use of Movicol half strength is then ceased. - Use of Movicol Half strength is recommenced 7 days prior to commencing treatment and is then consumed daily for 7 weeks until treatment is completed. Group 2 will be prescribed Metamucil (9 grams per day) consumed orally as 1 x 3 gram serve added to a 250ml glass of water at breakfast, lunch and dinner. The group will also be prescribed 1 x Nutralife Probiotic 50 supplement consumed orally per day. Prescription is as follows. - Use of Metamucil is commenced 7 days prior to attending for CT simulation. Once CT simulation is completed use of Metamucil is then ceased. - Use of Metamucil is recommenced 7 days prior to commencing treatment and is then consumed daily for 7 weeks until treatment is completed. Compliance will be checked by completion of medication diary for the laxatives and through packet return for the probiotic.
Sponsors
Nicole Weston
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator)
Eligibility
Sex/Gender
Male
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adult patients fifty years of age or older undergoing external bean radiotherapy (EBRT) to the intact prostate, using fiducial markers for position verification.
Exclusion criteria
Severe constipation, abdominal disease (Crohn’s disease, ulcerative colitis, irritable bowel syndrome), history of extensive abdominal surgery, patients using digoxin or salicylates. Individuals whose primary language is other than English.
Outcome results
None listed