Adverse effects of radiotherapy for pelvic cancer.
Conditions
Interventions
Trade Name: Trental
Product Name: Pentoxifylline
Product Code: n/a
Pharmaceutical Form: Modified-release tablet
INN or Proposed INN: pentoxifylline
CAS Number: 6493-05-6
Other descriptive name: 3,7
Sponsors
The Royal Marsden NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To test the benefits of oral Tocovid SupraBio (tocotrienols) with pentoxifylline (PTX) in patients suffering chronic gastrointestinal adverse effects following curative pelvic radiotherapy for cancer.;Secondary Objective: N/a.;Primary end point(s): Change at 12 months in the bowel disease subset of the Modified IBDQ Quality of Life questionnaire. ;Timepoint(s) of evaluation of this end point: Patients will be asked to complete a copy of the Modified IBDQ Quality of Life questionnaire pre-treatment (baseline) + 3, 6, 9, 12, 15, 18, 21 and 24 months post-randomisation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): i) Change at 12 months in rectal IBDQ bleeding score between the two groups in those patients presenting with grade 2, 3 or 4 bleeding. ii) Change at 12 months in IBDQ faecal incontinence score between the two groups in those patients presenting with grade 1 or greater incontinence. iii) Proportion of items graded as marked or severe (grade 3 or 4). iv) Physician assessment of rectal dysfunction using the modified CTCAE Version 4 grading. v) Patient self-assessments: QLQ–C30 and CR29 and the Gastrointestinal Symptom Rating Scale. vi) Photographic assessments of rectal mucosa. vii) Serum fibrosis marker levels. ;Timepoint(s) of evaluation of this end point: Patients will be asked to complete self-assessment questionnaires pre-treatment (baseline) + 3, 6, 9, 12, 15, 18, 21 and 24 months post-randomisation. Physician assessments and flexible sigmoidoscopy will be undertaken pre-treatment (baseline) + 12 and 24 months post-randomisation. Blood samples will be taken pre-treatment (baseline) + 3, 6, 9, 12, 18 and 24 months post-randomisation. | — |
Countries
United Kingdom
Contacts
Public ContactResearch Coordinator
The Institute of Cancer Research
Outcome results
None listed