Dietary advice combined with a salicylate, mineral and vitamin supplement (CV247) has some tumour static properties: a phase II study

Purpose This pilot study seeks to evaluate whether dietary intervention combined with an oral formulation of sodium salicylate, mineral and vitamin supplements (CV247) altered the rate of progression in patients with malignant disease. Design/methodology/approach A total of 37 patients were recruited from March 2001 to November 2001 and ran to September 2004. All patients had progressive malignancy at trial entry (def: at least two consecutive increases in tumour markers >10 per cent or radiological progression). Patients, were recommended a diet rich in fresh fruit, vegetables, low in saturated fats, salt and man‐made chemical supplements such as colours and preservatives together with oral CV247 (sodium salicylate, copper gluconate, manganese gluconate and ascorbic acid). Dietary compliance was monitored, from a subgroup, by monthly interviews with the trial dietitian recorded on a linear analogue scale. Quality of life was measured by monthly completion of a Rotterdam symptom check‐list questionnaire and tumour progression measured by radiological assessment and/or tumour markers. Findings The treatment was well tolerated and compliance with the diet was enthusiastic. Of the two patients with progressive metastatic ovarian carcinoma, one had stabilisation in the disease for five months, the other for 20 months. The 28 heavily pre‐treated patients (including those with metastatic prostate cancer) had no significant clinical response (52 per cent stabilisation for 3.5 months). Of the seven patients with early prostate cancer (no metastasis or hormonal therapy, with pre‐trial increasing PSA), six (86 per cent) had stabilisation of PSA with a mean duration of 17.2 months. Originality/value This study succeeded in evaluating whether dietary intervention combined with an oral formulation of sodium salicylate, mineral and vitamin supplements (CV247) altered the rate of progression in patients with malignant disease.