| Disease | PHASE II TRIAL TO EXPLORE GREEN TEA'S ANTINEOPLASTIC EFFECTS IN PATIENTS WITH ANDROGEN-INDEPENDENT PROSTATE CARCINOMA.
STUDY EVALUATED 42 PATIENTS WHO WERE ASYMPTOMATIC AND HAD MANIFESTED, PROGRESSIVE PROSTATE SPECIFIC ANTIGEN (PSA) ELEVATION WITH HORMONE THERAPY. CONTINUED USE OF LUTEINIZING HORMONE-RELEASING HORMONE AGONIST WAS PERMITTED; HOWEVER, PATIENTS WERE INELIGIBLE IF THEY HAD RECEIVED OTHER TREATMENTS FOR THEIR DISEASE IN THE PRECEDING 4 WEEKS OR IF THEY HAD RECEIVED A LONG-ACTING ANTIANDROGEN THERAPY IN THE PRECEDING 6 WEEKS. PATIENTS WERE INSTRUCTED TO TAKE 6 GRAMS OF GREEN TEA PER DAY ORALLY IN 6 DIVIDED DOSES. EACH DOSE CONTAINED 100 CALORIES AND 46 MG OF CAFFEINE. PATIENTS WERE MONITORED MONTHLY FOR RESPONSE AND TOXICITY.
TUMOR RESPONSE, DEFINED AS A DECLINE >/= 50% IN THE BASELINE PSA VALUE, OCCURRED IN A SINGLE PATIENT, OR 2% OF THE COHORT (95% CONFIDENCE INTERVAL, 1-14%). THIS ONE RESPONSE WAS NOT SUSTAINED BEYOND 2 MONTHS. AT THE END OF THE FIRST MONTH, THE MEDIAN CHANGE IN THE PSA VALUE FROM BASELINE FOR THE COHORT INCREASED BY 43%. GREEN TEA TOXICITY, USUALLY GRADE 1 OR 2, OCCURRED IN 69% OF PATIENTS AND INCLUDED NAUSEA, EMESIS, INSOMNIA, FATIGUE, DIARRHEA, ABDOMINAL PAIN, AND CONFUSION. HOWEVER, SIX EPISODES OF GRADE 3 TOXICITY AND ONE EPISODE OF GRADE 4 TOXICITY ALSO OCCURRED, WITH THE LATTER MANIFESTING AS SEVERE CONFUSION.
CONCLUSIONS:
GREEN TEA CARRIES LIMITED ANTINEOPLASTIC ACTIVITY, AS DEFINED BY A DECLINE IN PSA LEVELS, AMONG PATIENTS WITH ANDROGEN INDEPENDENT PROSTATE CARCINOMA. |