The effects of cranberry capsules on cystitis in men treated with radiation for prostate cancer
The efficacy of cranberry capsules in the prevention and management of acute radiation cystitis in men treated with radiation for prostate cancer
Creative Energy LTD
40 participants
Aug 7, 2012
Interventional
Conditions
Summary
The overarching aim of the proposed trial is to investigate whether or not cranberry capsules are superior to placebo control capsules in reducing the severity and incidence of acute radiation cystitis occurring in men with prostate cancer. Background Prostate cancer is the most common cancer among older men in developed countries. Cancer Statistics NZ reported that in 2008, 2798 non-Maori men were diagnosed with prostate cancer and 635 men (23%) died of this disease in that year. During that same year, 141 Maori men were diagnosed and 35 men (25%) died of the disease [1]. Treatment for prostate cancer can include surgery, radiation therapy and hormone therapy, depending on the stage, location, co-morbidities and patient preferences. Acute radiation-induced cystitis is a common side effect of radiation therapy to the pelvis, with up to 40% of men suffering from cystitis to some extent [2, 3]. Acute symptoms occur within weeks of radiation treatment and include urinary urgency, frequency, dysuria, and hematuria. Currently there is no effective treatment for radiation cystitis. Standard care for radiation cystitis in the Southern Blood and Cancer Service in Dunedin Hospital radiation cystitis is ural, a urinary alkalinizer which relieves symptoms but does not affect cystitis. Because radiation cystitis is caused by free radical damage to the bladder lining [4], therapies that decrease the number of free radicals in the bladder may decrease its severity [5]. Proanthocyanidins (PACs), phytochemicals found in the North American cranberry, have dose dependent radical scavenging, anti-bacterial and anti-carcinogenic properties [6-11]. A recent Cochrane Review reported that cranberry juice reduces the incidence of recurrent infectious cystitis (urinary tract infections) in young women by inhibiting adhesion of pathogenic E.coli bacteria to the bladder wall [12, 13]. The effect of cranberries on radiation cystitis has so far not been investigated. This double blinded placebo controlled pilot study will investigate the effect of cranberry capsules on the severity and incidence of acute radiation cystitis in men with prostate cancer. A shortened modified version of the Expanded Prostate Index Composite (EPIC) measure [14] will be used to assess the extent of cystitis References 1. MOH, Cancer Statistics New Zealand. New Zealand Ministry of Health, 2010. 2. McCammon et al. Int. J. Radiat. Oncol. Biol. Phys., 2009. 75(2): p. 413-420. 3. Pervez et al. Int. J. Radiat. Oncol. Biol. Phys., 2010. 76(1): p. 57-64. 4. Suresh et al. J. Clin. Pathol., 1993. 46(3): p. 228-231. 5. Greenberger, and Epperly. In Vivo, 2007. 21(2): p. 141-146. 6. Côté et al. Crit. Rev. Food. Sci. Nutr. , 2010. 50(7): p. 666-679. 7. Déziel et al. J. Cell. Biochem. , 2010. 111(3): p. 742-754. 8. Menghini et al. J. Biol. Regul. Homeost. Agents, 2011. 25(1): p. 27-35. 9. Pappas and Schaich. Critical Reviews in Food Science and Nutrition, 2009. 49: p. 741-781. 10. Seeram. J. Agric. Food Chem., 2008. 56: p. 627-629. 11. Seeram et al. J. Agric. Food Chem., 2004. 52: p. 2512-2517. 12. Jepson and Craig. Cochrane Database Syst. Rev., 2008. 23(1): p. CD001321. 13. Howell et al. BMC Infectious Diseases, 2010. 10: p. 94-105. 14. Wei et al. Urology, 2000. 56(6): p. 899-905.
Eligibility
Plain Language Summary
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Interventions
Patients who have given written informed consent will be randomized to to either the cranberry arm or the placebo arm by the PI, Dr Patries Herst. Each participant will be given a numbered brown glass bottle (patient 01 will have bottle 01 etc.) containing either 70 cranberry or 70 placebo capsules at the start of their RT treatment. The participants will take one capsule a day during breakfast from the first day of treatment and continue until all the capsules have been taken (10 weeks). Durning the trial, participants are not allowed to take foods, drinks or supplements containing cranberries, blueberries or blackberries and limit consumption of grapes and wine. The cranberry capsules contain 72mg proanthocyanidins (PACs) each.
Locations(1)
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ACTRN12611000887976