PPALM - Palm oil and Pentoxifylline Against Late Morbidity

Phase 2

Completed

• Conditions: Topic: Cancer; Subtopic: Colorectal Cancer, Bladder Cancer, Gynaecological Cancer, Prostate Cancer; Disease: Bladder (advanced), Bladder (superficial), Cervix, Ovary/Fallopian tube, Prostate, Rectum, Testis, Uterus/Endometrium, Vagina; Cancer

• Registration Number: ISRCTN17415294
• Lead Sponsor: Royal Marsden NHS Foundation Trust

Brief Summary

2022 Results article in https://doi.org/10.1016/j.radonc.2022.01.024 (added 11/02/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-01-12
• Study Completion: 2019-12-20
• Last Update Posted: 22 August 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Change at 12 months in the bowel disease subset of the Modified IBDQ Quality of Life questionnaire

Secondary Outcome Measures

Name	Time	Method
<br> 1. Change at 12 months in rectal IBDQ bleeding score between the two groups in those patients presenting with grade 2, 3 or 4 bleeding<br> 2. Change at 12 months in IBDQ faecal incontinence score between the two groups in those patients presenting with grade 1 or greater incontinence<br> 3. Proportion of items graded as marked or severe (grade 3 or 4)<br> 4. Physician assessment of rectal dysfunction based on the modified CTCAE Version 4 grading<br> 5. Patient self-assessments: QLQ-C30 and CR29 and the Gastrointestinal Symptom Rating Scale<br> 6. Photographic assessment of rectal mucosa<br> 7. Serum fibrosis marker levels<br>