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Journal cover: Nutrition & Food Science

Nutrition & Food Science

ISSN: 0034-6659

Online from: 1971

Subject Area: Health Care Management/Healthcare

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A randomised double-blind phase II study of lifestyle counselling and salicylate compounds in patients with progressive prostate cancer


Document Information:
Title:A randomised double-blind phase II study of lifestyle counselling and salicylate compounds in patients with progressive prostate cancer
Author(s):Robert Thomas, (Based at Primrose Oncology Unit, Bedford Hospital NHS Trust, Bedford, UK, Cranfield University, Cranfield, UK, and Addenbrooke's Hospital Cambridge University NHS Trust, Cambridge, UK), Roger Oakes, (Based at Ivy Medical Ltd, Waltham Abbey, UK), Julie Gordon, (Based at Primrose Oncology Unit, Bedford Hospital NHS Trust, Bedford, UK), Simon Russell, (Based at Addenbrooke's Hospital Cambridge University NHS Trust, Cambridge, UK), Mabel Blades, (Based at Nutrition and Dietetic Services, Rushden, UK), Madeleine Williams, (Based at Primrose Oncology Unit, Bedford Hospital NHS Trust, Bedford, UK)
Citation:Robert Thomas, Roger Oakes, Julie Gordon, Simon Russell, Mabel Blades, Madeleine Williams, (2009) "A randomised double-blind phase II study of lifestyle counselling and salicylate compounds in patients with progressive prostate cancer", Nutrition & Food Science, Vol. 39 Iss: 3, pp.295 - 305
Keywords:Cancer, Diet, Lifestyles, Patients
Article type:Research paper
DOI:10.1108/00346650910957555 (Permanent URL)
Publisher:Emerald Group Publishing Limited
Acknowledgements:The authors are grateful to Cambridge Laboratories and Ivy Medical for sponsoring this study, and acknowledge the contribution and dedication of the late John Carter made to the development of these interventions. The trial was supported by an unrestricted educational grant from Ivy Medical Chemicals and Cambridge laboratories, and conducted under the registration of the National Cancer Research Network (number 1372).
Abstract:

Purpose – Salicylate intake and lifestyle have been implicated in the aetiology of prostate cancer, but the purpose of this paper is to evaluate their influence on established cancer progression.

Design/methodology/approach – A randomised, double blind, phase II study involving 110 men whose prostate specific antigen (PSA), had risen in three consecutive values, >20 per cent over the proceeding six months. Men were counselled to eat less saturated fat, processed food, more fruit, vegetables and legumes; exercise more regularly and to stop smoking. They were then randomised to take sodium salicylate (SS) alone or SS combined with, vitamin C, copper and manganese gluconates (CV247). Patients took this daily, without other intervention, but were withdrawn if their PSA doubling time (PSAdt) shortened or their PSA rose >20 per cent from baseline.

Findings – Although there was no difference in outcome between the SS or CV247 (21 v 19 p?=?0.92), the intervention slowed or stopped the rate of PSA progression in 40 patients (36.4 per cent) for over one year. A further ten patients were stabilised for ten months. Patients least likely to stabilise had received previous radiotherapy or had a Gleason =7. These men welcomed this addition to active surveillance.

Originality/value – A further RCT in the sensitive subgroup, would determine the role adding SS to lifestyle counselling alone. These data suggest that this intervention would be welcomed by patients as if substantiated, it could potentially delay the need for more radical therapy and their associated toxicities



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