NCT02230800: PPALM

PPALM-Palm Oil and Pentoxifylline Against Late Morbidity

Completed Phase 2 Last updated 23 December 2019

What this trial tests

Phase 2 trial testing Tocovid SupraBio plus pentoxifylline in Long-term Adverse Effects of Radiotherapy for Pelvic Cancer in 62 participants. Completed in 20 December 2019.

Timeline

25 November 2014

Primary endpoint
20 December 2019

20 December 2019

Quick facts

Lead sponsor	Royal Marsden NHS Foundation Trust
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	62
Start date	25 November 2014
Primary completion	20 December 2019
Estimated completion	20 December 2019
Sites	1 location across United Kingdom

Drugs / interventions tested

• Tocovid SupraBio plus pentoxifylline — full drug profile →
• Matching placebos — full drug profile →

Conditions studied

• Long-term Adverse Effects of Radiotherapy for Pelvic Cancer — all drugs for Long-term Adverse Effects of Radiotherapy for Pelvic Cancer →

Sponsor

Royal Marsden NHS Foundation Trust

Who can join

18 and older, any sex, with Long-term Adverse Effects of Radiotherapy for Pelvic Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Expanding the therapeutic index of radiation therapy by normal tissue protection.
   Montay-Gruel P, Meziani L, Yakkala C, Vozenin MC. · · 2019 · cited 50× · PMID 29694234 · DOI 10.1259/bjr.20180008
2. Radiomitigators: Breakthroughs in Post-Radiation Recovery.
   Obrador E, Estrela JM, López-Blanch R, Moreno-Murciano P, et al · · 2026 · PMID 41897526 · DOI 10.3390/antiox15030381