Condition category
Cancer
Date applied
08/01/2015
Date assigned
12/01/2015
Last edited
17/06/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Contact information

Type

Scientific

Primary contact

Mrs Lone Gothard

ORCID ID

Contact details

Royal Marsden Hospital
Academic Radiotherapy Department
Downs Road
Sutton
SM2 5PT
United Kingdom

Additional identifiers

EudraCT number

2012-004211-31

ClinicalTrials.gov number

Protocol/serial number

17979

Study information

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

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

NRES Committee London-Central, 20/08/2014, ref: 14/LO/1122

Study design

Randomised; Interventional

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

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

Phase

Phase II

Drug names

1. Tocovid SupraBio
2. Pentoxifylline

Primary outcome measures

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 trial start date

26/07/2012

Overall trial end date

05/01/2019

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

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.

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

United Kingdom

Trial participating centre

Royal Marsden Hospital
Academic Radiotherapy Department Downs Road
Sutton
SM2 5PT
United Kingdom

Sponsor information

Organisation

Royal Marsden NHS Foundation Trust

Sponsor details

Fulham Road
London
SW3 6JJ
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

Malaysian Palm Oil Board (Malaysia)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

To be confirmed at a later date

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes