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 - PPALM - Palm oil and Pentoxifylline Against Late Morbidity

The Royal Marsden NHS Foundation Trust0 个研究点目标入组 62 人开始时间: 2014年6月21日最近更新: 2024年9月9日

适应症

试验速览

暂无简介。

•i) Age over 18 years.
•ii) Past history of a malignant pelvic neoplasm (T1-4 N0-2 M0) of the rectum, prostate, testis, bladder, uterine cervix, uterus, vagina, anal canal or ovary.
•iii) A minimum 12 months follow-up post-radiotherapy (24 months for patients with past history of stage T4 and/or N2 disease).
•iv) A maximum 7 years post-radiotherapy.
•v) No evidence of cancer recurrence.
•vi) Gastrointestinal symptoms attributable to prior radiotherapy: grade 2 or higher in any CTCAE Version 4 category, or grade 1 with difficult intermittent symptoms.
•vii) Symptoms are not relieved by appropriate life-style advice and medication over a 3-month period.
•viii) Physical and psychological fitness for Tocovid SupraBio+PTX therapy.
•ix) Written informed consent and availability for follow up.
•x) Willingness to keep to a specified level of dietary fat intake during the study.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 60
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 55

•i) Surgery for rectal cancer.
•ii) Contra-indication or other inability to undergo magnetic resonance imaging, if required to rule out malignancy.
•iii) Dietary supplementation containing alpha-tocopherol above a daily dose of 30mg at any time during the last three months.
•iv) Medication with pentoxifylline at any time since radiotherapy.
•v) Pregnancy or breast feeding.
•vi) 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.
•vii) Allergy to soya.

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