A Placebo-Controlled Double-Blinded Randomized Pilot Study of Combination Phytotherapy in Biochemically Recurrent...

Area of Science:

• Oncology
• Integrative Medicine
• Phytotherapy

Background:

• Men with recurrent prostate cancer often use natural supplements to delay disease progression.
• Research on phytotherapeutic agents is growing, but definitive recommendations are lacking.
• This pilot study assessed the feasibility of a combination phytotherapeutic intervention in men with biochemical recurrence.

Purpose of the Study:

• To evaluate the feasibility of a fully-powered study on a phytotherapeutic intervention.
• To examine the effects of a specific phytotherapeutic combination on prostate-specific antigen (PSA) doubling time.
• To assess secondary outcomes including prostate symptoms, quality of life, anxiety, and depression.

Main Methods:

• A double-blind, randomized, placebo-controlled trial involving 22 men with biochemically recurrent prostate cancer.
• Patients received either the active phytotherapeutic treatment (turmeric, resveratrol, green tea, broccoli sprouts) or placebo for 12 weeks.
• Feasibility endpoints included recruitment and procedures; secondary endpoints measured using validated questionnaires and PSA levels.

Main Results:

• The phytotherapeutic intervention was well-tolerated, with excellent adherence and acceptable procedures.
• No statistically significant differences in clinical outcomes were expected or observed in this pilot study.
• The active treatment group showed a trend towards an increased PSA log-slope (shorter PSA doubling time), while the placebo group showed no change.

Conclusions:

• A fully powered study of this combination phytotherapeutic intervention is feasible in men with biochemically recurrent prostate cancer.
• The intervention was well-tolerated and acceptable to participants.
• Further investigation is warranted to confirm the effects on PSA doubling time and clinical outcomes.