ISRCTN17415294已完成2 期
Randomised double-blind controlled phase II trial of Tocovid SupraBio in combination with pentoxifylline (PTX) in patients suffering long-term adverse effects of radiotherapy for pelvic cancer
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 62
研究概览
简要总结
2022 Results article in https://doi.org/10.1016/j.radonc.2022.01.024 (added 11/02/2022)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Age over 18 years.
- •2. Past history of a malignant pelvic neoplasm (T14 N02 M0) of the rectum, prostate, testis, bladder, uterine cervix, uterus, vagina, anal canal or ovary.
- •3. A minimum 12 months followup postradiotherapy (24 months for patients with past history of stage T4 and/or N2 disease)
- •4. A maximum 7 years postradiotherapy
- •5. No evidence of cancer recurrence
- •6. Gastrointestinal symptoms attributable to prior radiotherapy: grade 2 or higher in any CTCAE Version 4 category, or grade 1 with difficult intermittent symptoms
- •7. Symptoms are not relieved by appropriate lifestyle advice and medication over a 3 month period
- •8. Physical and psychological fitness for Tocovid SupraBio+PTX therapy
- •9. Written informed consent and availability for follow up
- •10. Willingness to keep to a specified level of dietary fat intake during the study
- •11. Symptoms are not relieved by appropriate life-style advice and medication over a 3-month period after optimal gastroenterological assessment
排除标准
- •1. Surgery for rectal cancer
- •2. Contraindication or other inability to undergo magnetic resonance imaging, if required to rule out malignancy
- •3. Dietary supplementation containing alphatocopherol above a daily dose of 30mg at any time during the last three months
- •4. Medication with pentoxifylline at any time since radiotherapy
- •5. Pregnancy or breast feeding
- •6. Ischaemic heart disease, uncontrolled hypertension, hypotension, acute myocardial infarction, cerebral haemorrhage, retinal haemorrhage, renal failure, liver failure and medication with insulin, ketorolac or vitamin K
- •7. Allergy to soya
- •8. Known hypersensitivity to the active constituent, pentoxifylline other methyl xanthines or any of the excipients’, as per SmPC for pentoxifylline
研究者
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