The effects of a herbal medicine combination in men with biochemically recurrent prostate cancer

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2014
INTERVENTION: A tablet/capsule combination of four (4) phytotherapeutic/herbal agents: A tablet combination of green tea (Camellia sinensis) standardised to contain green tea catechins 100 mg, turmeric (Curcuma longa) standardised to contain curcumin 100 mg, resveratrol (from Polygonum cuspidatum); 30 mg; and broccoli sprout extract (Brassica oleracea) 100 mg in capsule form. The proposed dose is two tablets and two capsules to be taken orally daily for twelve weeks. Drug tablet/capsule return will be used to monitor compliance. CONDITION: Prostate cancer PRIMARY OUTCOME: Feasibility and safety of a fully‐powered randomised controlled trial: ; * Recruitment and attrition rates, compliance with study procedures, number remaining on active surveillance at three months and after a further three month non‐treatment follow‐up ; * Adherence to intervention ; * Completion of surveys ; * Compliance with maintaining dietary intake of trial foods: Food Frequency Questionnaire, the “Dietary Questionnaire for Epidemiological Studies (DQES)”, Anti‐Cancer Council, Victoria. ; * Safety measures: LFTs; U&Es; FBG & INR (where relevant); record of any symptom relating to tolerance ; *Side‐effects of the interventions ; SECONDARY OUTCOME: PSA doubling time ; Serum PSA measured at baseline and end‐of treatment INCLUSION CRITERIA: Biochemically‐recurrent prostate cancer, PSA nadir + 2 ng/mL, and a moderate PSA rise (PSA doubling time of 3 ‐ 12 months) in men previously treated for histologically confirmed prostatic cancer with localised therapy.
Epistemonikos ID: e228b4d41bbdf526e9ebbf2cb3833e84daccc5ea
First added on: Aug 25, 2024