None listed
Conditions
Brief summary
This research study is looking at a combination of four herbs, which are common components of a healthy diet, in men who have been treated for prostate cancer, and have rising prostate specific antigen (PSA). Who is it for? You may be eligible to join this study if you are a male aged 18 years or above whose PSA is rising at a slow or moderate rate after surgery or radiotherapy for prostate cancer (referred to as 'biochemically recurrent prostate cancer'). Study details Participants in this study will be randomly allocated (by chance) to one of two groups. Participants in one group will take a combination of tablets and capsules containing green tea (Camellia sinensis), turmeric (Curcuma longa), resveratrol (which commonly occurs in grapes and wine) from giant knotweed (Polygonum cuspidatum) and broccoli sprout extract (Brassica oleracea). All of these are readily available over-the-counter in herbal combination products, and have all been tested in humans before. Participants in the other group will instead receive a placebo (inactive treatment). All participants will be asked to take two tablets and two capsules twice daily for 12 weeks. Participants will not know to which group they have been allocated until after the study is completed. Participants will have their PSA doubling time assessed at 3 months to determine any effect of treatment. It is thought that the natural herbal treatments may slow the rate at which PSA rises, and may also help to reduce any lingering side-effects following treatment, and improve quality of life. This is an initial small (pilot) study that may form the basis of a larger trial in the future.
Interventions
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 use
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.
Sponsors
University of Melbourne
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No
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.
Exclusion criteria
* clinical suspicion or evidence of metastastic disease * atypical prostate carcinoma histology (eg small cell, adenoid cystic) * hypogonadal men (eg primary testicular failure; pituitary tumour) * concurrent chemotherapy * prior cytotoxic chemotherapy or androgen ablative therapy for recurrent disease * currently receiving biological response modifiers, or high dose prednisolone (50 mg/day or more)
Outcome results
None listed