PPALM - Palm oil and Pentoxifylline Against Late Morbidity
| ISRCTN | ISRCTN17415294 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17415294 |
| EudraCT/CTIS number | 2012-004211-31 |
| ClinicalTrials.gov number | NCT02230800 |
| Secondary identifying numbers | 17979 |
- Submission date
- 08/01/2015
- Registration date
- 12/01/2015
- Last edited
- 12/08/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Contact information
Mrs Lone Gothard
Scientific
Scientific
Royal Marsden Hospital
Academic Radiotherapy Department
Downs Road
Sutton
SM2 5PT
United Kingdom
Study information
| Study design | Randomised; Interventional |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | 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 |
| Study acronym | PPALM |
| Study hypothesis | Aim: 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. |
| Ethics approval(s) | NRES Committee London-Central, 20/08/2014, ref: 14/LO/1122 |
| Condition | 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 |
| Intervention | Randomisation: Treatment allocation will be in a 2:1 ratio of Tocovid SupraBio+PTX:Matched placebo and will be based on computer generated random permuted blocks. Placebos, Matching placebos bd for 12 months; Tocovid SupraBio, 200mg po bd plus pentoxifylline (PTX) 400mg po bd for 12 months; Follow Up Length: 12 month(s) |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | 1. Tocovid SupraBio 2. Pentoxifylline |
| Primary outcome measure | 1. Change at 12 months in the bowel disease subset of the Modified IBDQ Quality of Life questionnaire |
| Secondary outcome measures | 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 2. Change at 12 months in IBDQ faecal incontinence score between the two groups in those patients presenting with grade 1 or greater incontinence 3. Proportion of items graded as marked or severe (grade 3 or 4) 4. Physician assessment of rectal dysfunction based on the modified CTCAE Version 4 grading 5. Patient self-assessments: QLQ-C30 and CR29 and the Gastrointestinal Symptom Rating Scale 6. Photographic assessment of rectal mucosa 7. Serum fibrosis marker levels |
| Overall study start date | 26/07/2012 |
| Overall study end date | 20/12/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 117; UK Sample Size: 117; Description: 99 patients will provide 85% power to detect a difference in Modified Inflammatory Bowel Disease Questionnaire bowel subset score of 7.5, which is considered a worthwhile improvement in response to 12 months of Tocovid SupraBio+PTX compared to placebo. 117 patients will be recruited to allow for a 15% drop out rate. |
| Total final enrolment | 62 |
| Participant 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 |
| Participant 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 |
| Recruitment start date | 25/11/2014 |
| Recruitment end date | 05/01/2017 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Royal Marsden Hospital
Academic Radiotherapy Department
Downs Road
Sutton
SM2 5PT
United Kingdom
Downs Road
Sutton
SM2 5PT
United Kingdom
Sponsor information
Royal Marsden NHS Foundation Trust
Hospital/treatment centre
Hospital/treatment centre
Fulham Road
London
SW3 6JJ
England
United Kingdom
"ROR" |
https://ror.org/0008wzh48 |
|---|
Funders
Funder type
Government
Malaysian Palm Oil Board (Malaysia)
No information available
Results and Publications
| Intention to publish date | 31/12/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | To be confirmed at a later date |
| IPD sharing plan | The datasets generated and/or analysed are available on request from the PPALM trial PI, Dr Alexandra Taylor (Alexandra.taylor@rmh.nhs.uk), via completion of a data access request form after such time that the primary analysis publication and any other key analyses have been completed. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 12/12/2020 | 10/01/2022 | No | No | |
| Results article | 01/03/2022 | 11/02/2022 | Yes | No | |
| Protocol file | version 6.0 | 26/06/2017 | 12/08/2022 | No | No |
| HRA research summary | 26/07/2023 | No | No |
Additional files
Editorial Notes
12/08/2022: Uploaded protocol (not peer-reviewed) as an additional file.
11/02/2022: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
14/01/2022: The IPD sharing statement has been added and the IPD sharing summary updated accordingly.
10/01/2022: The EudraCT basic results link has been added.
05/10/2020: The overall end date was changed from 30/09/2019 to 20/12/2019.
12/06/2020: The intention to publish date was changed from 31/12/2019 to 31/12/2020.
23/07/2019: The following changes were made to the trial record:
1. ClinicalTrials.gov number added.
2. The overall end date was changed from 05/01/2019 to 30/09/2019.
3. The intention to publish date was added.
