Date post: | 17-Dec-2015 |
Category: |
Documents |
Upload: | reynard-blankenship |
View: | 216 times |
Download: | 2 times |
BROOKLYN 2
RADIOTHERAPY
Patries HERST
Sat 31st Aug 2013
Session 1 / Talk 1
09:20 – 09:46
ABSTRACTPurpose. Acute radiation-induced cystitis is a common side effect of radiation therapy to the pelvis, with up to 40% of prostate cancer patients suffering from cystitis to some extent. Currently there is no effective treatment for radiation cystitis. Here we investigate the effect of cranberry capsules on the extent of radiation-induced cystitis in prostate cancer patients in a double blinded RCT.Methods and materials. A total of 40 men receiving radiation therapy for prostate cancer at the Department of Radiation Therapy in Dunedin Hospital participated in this trial; 20 men were randomized to the cranberry arm and 20 were randomized to the placebo arm. The men took one capsule a day during breakfast from the first day of treatment for 70 days. Patients, clinicians and research assistants were blinded to the content of the capsules. Severity of cystitis was assessed using the modified urinary domain of the Expanded Prostate Cancer Index Composite (EPIC) scale. Items include severity of symptoms (pain, blood in urine, urinary frequency during day or night, leakage, use of pads and URAL sachets) as well as their effect on daily life.Results. Cranberry capsules significantly decreased the level of pain associated with acute radiation cystitis but did not affect the other EPIC measures.
Cranberry capsulesfor Radiation cystitis: a pilot RCT
Katelin Hamilton, Noelle Bennett, Patries Herst*
August 2013
Radiation cystitis in 60-90% of prostate patients
Damage to the lining of the bladder wall
seepage of acidic urine into the underlying tissues
inflammation, compromised detrussor muscle functioning
Symptoms similar to UTIs without infection:
Pain/Burning Weak stream, incomplete emptying Poor control, leakage, dripping Urgency
Background
TreatmentCurrently no standard treatment to prevent or decrease the severity of radiation cystitis
URAL treats the symptoms but not the inflammation
Cranberries reduce the incidence of UTIs in young women (Cochrane review in 2009)
Anecdotally, cranberry capsules seemed to reduce radiation cystitis in Dunedin patients
Campbell et al (2003) randomized unblinded comparison between cranberry juice and apple juice in 112 men with prostate cancerNo significant difference between study arms
Cowan et al (2012) placebo-controlled, double blinded trial of cranberry juice and placebo in 128 women with uterine/bladder cancer.Trend for decrease in urinary symptoms but not significant
HypothesisCranberry capsules are superior to placebo in decreasing the severity of radiation cystitis.
Bonetta and Pierro (2012)
standardized enteric coated cranberry tablets against nothing on radiation cystitis in 370 prostate cancer patients
Decreased levels of pain, urgency and day and night time frequencies (p<0.01)
Not blinded, randomization unclear
Take home message
Use standardized capsules
Use placebo capsules for double blinding
Be aware of compliance issues
Informed Consent
Randomization
Cranberry Capsules Placebo Capsules
1 Capsule a day for 10 weeks
1. Severity of cystitis2. URAL usage
CT Scan
Start RT
2 weeks after RT completion
Eligibility
•IMRT for prostate cancer•No previous RT to pelvis•No systemic disease•Karnofski score>70
Assessment
Modified EPIC: 2x week during and 1x week for 4 weeks after tmt
Protocol: Stage II RCT: 40 patients
Measurements: EPIC
Expanded Prostate Index Composite: Urinary Domain: both symptoms AND effect on QoL
Scores were taken 2x a week, subtracted from baseline score and averaged over the number of assessments to give average increase in EPIC scores for each patient
Patients scores are averaged to give average increase in EPIC scores for each cohort
Randomized41
Cranberry Capsules21
Placebo Capsules20
Non-Compliance1
Non-Compliance1
Cranberry Completed20
Placebo Completed19
Participants for Analysis39
Symptoms
In the last few days have you had:
Pain: how often: “never” to “more than once a day” Leakage: how often: “never” to “more than once a day”Control: total to none whatsoeverPads: how many: “none” to “more than 2”URAL: how often: “rarely” to “more than once a day”Blood: how often: “rarely” to “more than once a day”
Symptomsn=20n=19
0.03
P value
pain 0.03
leakage 0.14
control 0.94
pads 0.49
URAL 0.54
blood 0.85
No cystitis : 10/39 (26%)Cranberries: 7/20 (35%)Placebos: 3/19 (16%)
Ave
rag
e In
crea
se in
EP
IC S
core
Quality of Life
From “no bother at all” to “big problem”,
how much bother have the following been:
Pain/burning upon urinationDripping/leakingWeak stream/incomplete emptyingDay time frequencyNight time frequency (nocturia)Blood in urineOverall
P value
pain 0.04
leakage 0.67
weak stream 0.68
frequency 0.49
nocturia 0.12
blood 0.72
overall 0.64
Quality of Life
0.04
n=20n=19
No bother: 4/39 (10%)Cranberries: 4/20 (20%)Placebos: 0/19 (0%)
Ave
rag
e In
crea
se in
EP
IC S
core
Major Confounder
Over-hydration (‘full bladder syndrome”)
14 patients had high hydration levels (8 cranberries, 6 controls)
25 patients had low hydration levels (12 cranberries, 13 controls)
n=14n=25
0.01
P value
pain 0.52
leakage 0.31
control 0.33
pads 0.25
URAL 0.01
blood 0.10
SymptomsA
vera
ge
Incr
ease
in E
PIC
Sco
re
Inconsistent advice
P value
pain 0.93
leakage 0.22
weak stream 0.56
frequency 0.31
nocturia 0.27
blood 0.27
overall 0.08
Quality of Lifen=14n=25
Ave
rag
e In
crea
se in
EP
IC S
core
Other possible confounders
High baseline cystitis scores
19/39 (49%) men had baseline scores >1 for at least one of the measures
Increase from baseline is highest if baseline is 0 (0-4), compared with 1 (0-3) or 2 (0-2) or 3 (0-1) or 4 (0)
12 men on placebo capsules and 7 men on cranberry capsules had high baseline scores. Placebo results likely to be artificially low.
Inconsistent advice regarding URAL usage
Conclusion
Cranberry capsules may decrease certain aspects of radiation cystitis.
NextLarge multicentre RCT in NZ
Standardized capsules, placebo capsules
Exclude men with high baseline scores
Consistent hydration levels
URAL given only when symptoms reach 2
Trial Participants
Staff from Southern DHB
Funding:
Acknowledgements