Status:
COMPLETED
PPALM-Palm Oil and Pentoxifylline Against Late Morbidity
Lead Sponsor:
Royal Marsden NHS Foundation Trust
Collaborating Sponsors:
Malaysia Palm Oil Board
Conditions:
Long-term Adverse Effects of Radiotherapy for Pelvic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Side effects are common after treatment with radiotherapy for tumours in the pelvis and can affect the way the bowel and urinary system work as well as causing sexual difficulties, skin damage and bon...
Eligibility Criteria
Inclusion
- Inclusion Criteria -
- Age over 18 years.
- Past history of a malignant pelvic neoplasm (T1-4 N0-2 M0) of the rectum, prostate, testis, bladder, uterine cervix, uterus, vagina, vulva, anal canal or ovary.
- A minimum 12 months follow-up post-radiotherapy (24 months for patients with past history of stage T4 and/or N2 disease).
- A maximum 7 years post-radiotherapy
- No evidence of cancer recurrence.
- Gastrointestinal symptoms attributable to prior radiotherapy: grade 2 or higher in any CTCAE Version 4 category, or grade 1 with difficult intermittent symptoms.
- Symptoms are not relieved by appropriate life-style advice and medication over a 3-month period.
- Physical and psychological fitness for Tocovid SupraBio+PTX therapy.
- Written informed consent and availability for follow up.
- Willingness to keep to a specified level of dietary fat intake during the study.
- Exclusion Criteria -
- Surgery for rectal cancer.
- Contra-indication or other inability to undergo magnetic resonance imaging, if required to rule out malignancy.
- Dietary supplementation containing alpha-tocopherol above a daily dose of 30mg at any time during the last three months.
- Medication with pentoxifylline at any time since radiotherapy.
- Pregnancy or breast feeding.
- 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.
- Allergy to soya.
- Known hypersensitivity to the active constituent, pentoxifylline other methyl xanthines or any of the excipients', as per SmPC for pentoxifylline.
Exclusion
Key Trial Info
Start Date :
November 25 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 20 2019
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT02230800
Start Date
November 25 2014
End Date
December 20 2019
Last Update
December 23 2019
Active Locations (1)
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1
The Royal Marsden NHS Foundation Trust
London, United Kingdom, SW3 6JJ