PPALM-Palm Oil and Pentoxifylline Against Late Morbidity

Phase 2

Completed

• Conditions: Long-term Adverse Effects of Radiotherapy for Pelvic Cancer
• Interventions: Drug: Tocovid SupraBio plus pentoxifylline; Drug: Matching placebos

• Registration Number: NCT02230800
• Lead Sponsor: Royal Marsden NHS Foundation Trust

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 bone problems. Problems in the bowel, bladder, sexual organs and skin mostly result from thickening of the tissues in response to radiotherapy, a process called "fibrosis". Fibrosis often worsens over time.

There has been progress in treating bowel symptoms which usually are the worst problem after radiotherapy. However, even after receiving the best possible treatments, while many patients are better, they are often not cured of all their difficult problems.

For some years, it has been hypothesised that if fibrosis could be treated then symptoms would improve. Recent research in laboratory animals has suggested that an effective treatment for radiation-induced fibrosis is combination therapy with a drug called Pentoxifylline together with a nutritional supplement containing gamma-tocotrienol (Tocovid SupraBio), a substance derived from palm oil. Both of these agents are simple to take and side effects are rare.

This study will recruit volunteers who continue to have difficult side effects after previous radiotherapy to the pelvis despite receiving the best treatments available from a unique clinic at The Royal Marsden which has pioneered treatment for bowel problems after radiotherapy. Two out of every three volunteers who take part, will be randomly assigned to treatment with Pentoxifylline and Tocovid SupraBio, while one out of three will receive dummy pills. Neither the patients nor the staff assessing them will know which treatment they have been given. Volunteers take the active treatments or dummy tablets for a year and will be assessed regularly while on treatment and for a year afterwards. This study will show whether active treatment is more effective than dummy pills in improving the symptoms caused by radiation-induced fibrosis.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-08-29
• Study First Submitted QC: 2014-09-02
• Study First Posted: 2014-09-03
• Study Start: 2014-11-25
• Status Verified: 2019-01
• Primary Completion: 2019-12-20
• Study Completion: 2019-12-20
• Last Update Submitted: 2019-12-20
• Last Update Posted: 2019-12-23

Recruitment & Eligibility

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

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tocovid SupraBio plus pentoxifylline (PTX)	Tocovid SupraBio plus pentoxifylline	Tocovid SupraBio\* 200mg po bd plus pentoxifylline (PTX) 400mg po bd for 12 months.
Matching placebos	Matching placebos	Matching placebos bd for 12 months.

Primary Outcome Measures

Name	Time	Method
Change at 12 months in the bowel disease subset of the Modified IBDQ Quality of Life questionnaire.	Endpoint will be assessed pre-treatment and 3, 6, 9, 12, 18 & 24 months post-treatment.

Secondary Outcome Measures

Name	Time	Method
Physician assessment of rectal dysfunction based on the modified CTCAE Version 4 grading.	Endpoint will be assessed pre-treatment and 6, 12 & 24 months post-treatment.
Patient self-assessments: QLQ-C30 and CR29 and the Gastrointestinal Symptom Rating Scale.	Endpoint will be assessed pre-treatment and 3, 6, 9, 12, 18 & 24 months post-treatment.
Serum fibrosis marker levels.	Endpoint will be assessed pre-treatment and 3, 6, 9, 12, 18 & 24 months post-treatment.
Proportion of items graded as marked or severe (grade 3 or 4).	Endpoint will be assessed pre-treatment and 3, 6, 9, 12, 18 & 24 months post-treatment.
Photographic assessment of rectal mucosa.	Endpoint will be assessed pre-treatment and 12 & 24 months post-treatment
Change at 12 months in rectal IBDQ bleeding score between the two groups in those patients presenting with grade 2, 3 or 4 bleeding.	Endpoint will be assessed pre-treatment and 3, 6, 9, 12, 18 & 24 months post-treatment.
Change at 12 months in IBDQ faecal incontinence score between the two groups in those patients presenting with grade 1 or greater incontinence.	Endpoint will be assessed pre-treatment and 3, 6, 9, 12, 18 & 24 months post-treatment.

Trial Locations

Locations (1)

The Royal Marsden NHS Foundation Trust; 🇬🇧 London, United Kingdom