Effect of oral sucralfate on late rectal injury associated with radiotherapy for prostate cancer: A double-blind, randomized trial
ABSTRACT To assess whether oral sucralfate is effective in preventing late rectal injury in prostate cancer patients treated with radiotherapy.
A double-blind, placebo-controlled, randomized trial was conducted across four institutions in Australia. Patients receiving definitive radiotherapy for prostate cancer were randomized to receive either 3 g of oral sucralfate suspension or placebo twice daily. Data on patients' symptoms were collected for 2 years, and flexible sigmoidoscopy was scheduled at 12 months after treatment.
A total of 338 patients were randomized, of whom 298 had adequate follow-up data available for an analysis of late symptoms. Of the 298 patients, 143 were randomized to receive sucralfate and 155 placebo. The cumulative incidence of Radiation Therapy Oncology Group Grade 2 or worse late rectal toxicity at 2 years was 28% for placebo and 22% for the sucralfate arm (p = 0.23; 95% confidence interval for the difference -3% to 16%). Seventeen percent of patients in the sucralfate group had significant bleeding (Grade 2 or worse) compared with 23% in the placebo group (p = 0.18, 95% confidence interval -15% to 3%). No statistically significant difference was found between the two groups with respect to bowel frequency (p = 0.99), mucus discharge (p = 0.64), or fecal incontinence (p = 0.90). Sigmoidoscopy findings showed a nonstatistically significant reduction in Grade 2 or worse rectal changes from 32% with placebo to 27% in the sucralfate group (p = 0.25).
This trial demonstrated no statistically significant reduction in the incidence of late rectal toxicity in patients randomized to receive sucralfate. However, this result was considered inconclusive, because the trial was unable to exclude clinically important differences in the late toxicity rates.
Conference Paper: A Fully Implanted 1 W, 18 GHz FET[Show abstract] [Hide abstract]
ABSTRACT: The reliability of power FET's is strongly affected by the local uniformity of the active layer. Therefore an implanted layer has been optimized for 2.4 mm power devices. The main features of the devices are a 0.7 um gate length, a 50 um unit gate width and a via-hole source grounding. An output power of 1 W at 18 GHz with 6 dB linear gain has been measured. This result is the best ever reported for implanted power devices, and demonstrates the potentiality of ion implantation for power FET's production.Microwave Conference, 1985. 15th European; 10/1985
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ABSTRACT: Despite advances in pelvic radiotherapy, damage to normal tissue can lead to chronic gastrointestinal problems. The frequency with which this affects quality of life is controversial. Faecal incontinence is not widely perceived to be a major issue after pelvic radiotherapy. The aim of this paper is to review the frequency and mechanisms for the development of faecal incontinence after pelvic radiotherapy, and to review treatment options for faecally incontinent patients. A search of original literature was carried out using MEDLINE and EMBASE databases from 1966 to 2005. The reliability of the published data is poor because patients frequently fail to admit to faecal incontinence, and because prospective studies are lacking that assess faecal incontinence as a specific end point using adequate, validated and reproducible methodology. The published rates of late new-onset faecal incontinence after pelvic radiation are between 3% and 53%. Patients treated for prostate rather than gynaecological, bladder, rectal or anal cancer may have a lower rate. Only 8-56% of affected patients state that faecal incontinence reduces their quality of life. Studies examining the physiological changes occurring after radiotherapy are generally not adequately controlled or powered, assessment of ano-rectal function is rarely comprehensive and loss of patients to follow-up frequently makes it difficult to extrapolate results to a wider population. Where there is agreement over the physiological changes that occur after radiotherapy, it is not clear at what threshold these changes cause symptoms. No prospective studies of any non-surgical treatment for faecal incontinence after radiotherapy have been published. Surgery other than colostomy probably carries a high risk of complications in this group of patients, but few data have been published. Now that improvements in outcome from combination treatments, including radiotherapy for pelvic cancer, are being achieved, it is time that serious attention is paid to determining how frequently significant gastrointestinal toxicity arises, and how best to optimise the quality of life of long-term survivors.Clinical Oncology 10/2005; 17(6):469-77. DOI:10.1016/j.clon.2005.02.008 · 2.83 Impact Factor
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ABSTRACT: To review published studies evaluating interventions for the prevention and management of radiation skin reactions/dermatitis. Research studies, review articles, and clinical practice guidelines. There is insufficient evidence in the literature to recommend specific topical or oral agents in the prevention or management of skin reactions. Recent limited evidence suggests that the use of calendula cream may reduce the incidence of grade 2 and 3 reactions in women with breast cancer. Additionally, early studies evaluating the use of barrier films or creams may improve moist desquamation. Oncology nurses need to increase their awareness of the evidence or lack of evidence when recommending interventions to their patients. Further research is required to evaluate interventions in the prevention and management of radiation dermatitis.Seminars in Oncology Nursing 09/2006; 22(3):163-73. DOI:10.1016/j.soncn.2006.04.004