So I literally just walked through the door after a four-hour delay from my
flight. So thank you for waiting. So I'm here to talk today about a
randomized control trial that we conducted under Central West Cancer Care
Centre in Orange. So as you're probably aware is that the prostate can't--
prostate isn't a fixed gland and it moves around in the pelvis and,
particularly when we're delivering daily radiation treatment,
we need the bowel to be emptied, which allows optimal positioning of the
prostate gland. If the bowel is too full of gas or matter, that affects the
positioning of the prostate, which may, I guess, result in a lower than desired
dose of the radiation to the prostate and then too much radiation to our healthy
tissue, particularly being our rectal tissue. So in the literature, there's a
lack of prospective adequately powered trials to identify if any one intervention
can result in a consistently empty rectum. And in the published literature,
they compare laxatives to no intervention at all and there currently
haven't been any published studies which compare two different types of laxatives.
And there are a variety of laxatives that are used throughout Australia and, I
guess, predominantly your bulking laxatives like Metamucil or fibre gel
and the osmotic laxatives like Movicol. And at the Central West Cancer Care
Centre in Orange, our current protocol is to use Movicol plus a low gas diet. So
within the study as well, we decided to look at the use of probiotics in this
setting. So probiotics is a very novel area of research at the present time and
a lot of work has been done in the field with irritable bowel and also
inflammatory bowel disease. And studies have shown that use of probiotics can
help to reduce gas in this population. What we also know from the research is
that the homeostasis of our gut microbes can be altered during radiation therapy
to the gastrointestinal tract and use of probiotics might help to reduce that
inflammation caused by the radiation. There's been one study conducted by
Ki and colleagues, which use probiotics in this setting
in attempt to reduce rectal gas levels for radiation therapy treatment to the
prostate and results showed a trend towards gas reduction but their study
numbers were quite small. So our study design was a single blinded randomised
control trial comparing two different types of laxatives, so osmotic
laxative, Movicol, being our standard care arm and ourother arm was
a bulking laxative with the Metamucil plus the probiotic agent. And both
groups followed our standard low gas diet, which removed cruciferous
vegetables, carbonated beverages like beer and soft drinks, gastric irritants
like caffeine and a large amounts of alcohol and spicy foods. So our study
aims were to determine if a bulking laxative combined with a probiotic is
more effective than the osmotic laxatives at reducing rectal gas during
radiation treatment. So our objectives were to determine if there was a
difference in rectal gas between the two treatment arms, to see if there was any
difference in the treatment related toxicities between the two treatment
arms, also to assess compliance to the low gas diet, the laxatives and the
probiotic regimen - and ethics was approved our local ethics committee. So
our inclusion criteria were adult males undergoing external beam radiation
therapy to the intact prostate where fiducial markers had been inserted for
position verification. Our exclusion criteria included severe constipation,
abdominal disease like Crohn's or ulcerative colitis, history of extensive
abdominal surgery, patients who are on digoxin or salicylates as their
absorption is impaired with Metamucil, and individuals whose primary language
was other than English. And our study was conducted between June to December last
year. So rectal gas was measured in this study on a scale of 1 to 5 - so ordinal
scale - where 1 represented no gas present in the bowel and 5 being 100
percent of the bowel being occupied by gas and this method has been reported in
the literature by McNair and colleagues previously. We also
got participants to record a three-day food diary at four different time points
during their treatment. From this, we analyzed the fibre and fluid intakes. We
got them to self-report their stool frequency and consistency using the
Bristol seven-point scale and we also got them to self record their laxative,
probiotic use during this time as well. So patients were analysed according to
the intention-to-treat principle. We couldn't use a priori effect size
calculation because of the absence of previous published studies, as other
studies had compared a laxative to no intervention at all. So power calculation
was determined for the study with an aim to recruit ten patients per
treatment arm for a small to medium effect size. So 29 patients were screened
and approached to participate in the study and 17 consented. Nine patients
were recruited into the osmotic laxatives arm and eight into the bulking
laxative probiotic arm. So during the treatment timeframe, we collected 433
computed tomography CT scans, which we use to analyse the rectal gas level. 180
scans were analysed from the osmotic laxative arm and 253 from the bulking
laxative arm. And we looked at the difference in the number of scans per
group and it trended towards significance because what we were
finding is that our bulking laxative group were tending to fail
their CBCT scans more often than our osmotic laxatives group. So the mean age
of our participants was 74 years. I guess, of note for our centre in
particular because we're a rural treatment centre, 35 percent of our
patients traveled for treatment daily and 41 percent lived away from home while
receiving their treatment. With compliance to their laxative use, 86
percent in the bulking laxative and 88 percent in the osmotic laxative arm
reported regular consumption of the laxatives. With the probiotic, we had
68% recording rate but unfortunately three of the handed-in food diaries went
missing over the Christmas period so we did lose a little bit of data from three
patients. When we came to looking at compliance to our low gas diet, of the
diaries that were collected, only three participants reported consuming gas
forming foods, and those in particular were eggs, coffee intake greater than
four cups a day, a curry and then cruciferous vegetables. Fibre intakes
were higher in our bulking laxative group and that is because the Metamucil
provides an additional nine grams of fibre per day, so it was 27 grams for the
bulking laxative group compared to 19.8 grams in our
osmotic laxative group. When looking at the stool consistency with our
participants, participants in the osmotic laxative group reported a
change in their stool pretty much from commencement of taking the Movicol.
So pre-studied stool type was a type four from the Bristol stool chart and
went to a type five on commencement of the Movicol. Within our Metamucil
group, they're still type-- remained a type four throughout the duration of their
treatment. We didn't have from the food diaries many patients report any
treatment-related toxicities, with only one patient from each treatment arm
reporting diarrhea in week 7 of their treatment. So when we looked at the
CBCT scans, what we found is that participants in the bulking laxative
group had a statistically significant higher proportion of scans which
received a rectal gas rating of three or above.
So there's 43% from our Metamucil group compared to 22 in our Movicol group.
And as you can see from the scan, there's 46 percent of our Movicol group who
had a rectal gas rating of one. So when we explored this further, what we
found is that the odds of a higher rectal gas rating were increased by
3.2 times for the bulking laxative and probiotic arm. And when we
look to see if the're higher fibre intakes were a contributing factor to
this, when we put fibre into the statistical model, we
found that fiber was not a contributing factor to the higher rectal gas levels.
We also looked at how often our patients were failing their CBT scans from either
having too much matter or too much gas in the bowel and our median proportion of
scans rated as gas fails were higher in our bulking laxative group compared to
our osmotic laxative group but that result wasn't significant. And there was
no difference between the groups and the number of rectum fails but as you can
probably see on the graph, down the bottom, there are three patients in
particular from our Metamucil group who had quite high number of gas fails
throughout their treatment. And so as we're aware this is one of the first
studies to compare the common laxatives used in the Australian setting with
patients who are undergoing prostate-- radiation therapy for prostate
cancer. And what we found that the osmotic laxative is more effective than
the bulking laxative and probiotic at achieving lower rectal gas levels for
treatment and that higher fibre intakes weren't a contributing factor to
increased gas levels. So the effect of the osmotic laxative drawing water into the
bowel made stools looser, resulting in an early and consistent bowel evacuation
before treatmen, compared to the use of the bulking laxatives which stimulated
peristalsis through increasing stool bulk - was not as effective at
consistently emptying bowels before treatment. So in terms of further
research, I guess one of the flaws from this study is that unfortunately we
weren't able to use a more objective measure to measure rectal gas volume and
also we didn't quite meet our target in terms of our participant numbers.
Also, looking to explore the role of probiotics further in this setting,
ideally we would have liked to have used them with the Movicol group as
well but that was just funding issues pertaining to that. Because a lot of our
patients also travel, looking at the the impact of stress on travel, of not
being able to work while they're having their treatment, from being away from
their family, changes in daily diet and routine which may impact on their bowel
habits. Also looking at the use of long term effects of Movicol on gut
microbiota and the role that probiotics may play in this setting. And
then because everyone's own gut flora is unique and individual and we need to
explore further individual influences that affect rectal fullness and rectal
gas levels. So that brings me to the end of my presentation so I guess just a
thank you to the HETI and Rural Research Capacity Building Program as
this project was conducted as part of that program and Georgina Luscombe from
the University of Sydney for mentoring and assistance with data collection and
analysis. Thank you.
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