Clinical Trial: PPALM-Palm Oil and Pentoxifylline Against Late Morbidity

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Randomised Double-blind Placebo Controlled Phase II Trial of Tocovid SupraBio in Combination With Pentoxifylline (PTX) in Patients Suffering Long-term Adverse Effects of R

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 treatmen

Detailed Summary:
Sponsor: Royal Marsden NHS Foundation Trust

Current Primary Outcome: Change at 12 months in the bowel disease subset of the Modified IBDQ Quality of Life questionnaire. [ Time Frame: Endpoint will be assessed pre-treatment and 3, 6, 9, 12, 18 & 24 months post-treatment. ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change at 12 months in rectal IBDQ bleeding score between the two groups in those patients presenting with grade 2, 3 or 4 bleeding. [ Time Frame: 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. [ Time Frame: 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). [ Time Frame: Endpoint will be assessed pre-treatment and 3, 6, 9, 12, 18 & 24 months post-treatment. ]
  • Physician assessment of rectal dysfunction based on the modified CTCAE Version 4 grading. [ Time Frame: 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. [ Time Frame: Endpoint will be assessed pre-treatment and 3, 6, 9, 12, 18 & 24 months post-treatment. ]
  • Photographic assessment of rectal mucosa. [ Time Frame: Endpoint will be assessed pre-treatment and 12 & 24 months post-treatment ]
  • Serum fibrosis marker levels. [ Time Frame: Endpoint will be assessed pre-treatment and 3, 6, 9, 12, 18 & 24 months post-treatment. ]


Original Secondary Outcome: Same as current

Information By: Royal Marsden NHS Foundation Trust

Dates:
Date Received: August 29, 2014
Date Started: January 2015
Date Completion: September 2019
Last Updated: March 1, 2017
Last Verified: February 2017