Trial Information

Guaraná ("Paullinia Cupana") for Chemotherapy Related Fatigue in Breast Cancer Patients: Results Of A Pilot Double Blind Randomized Study

The aim of this study is evaluate the favourable effects of Guaraná in quality of life and
Fatigue in patients undergoing Chemotherapy treatment for Breast Cancer. After approval by
our Institutional Review Board, we included consenting patients with a histological
diagnosis of Breast Cancer for whom Chemotherapy was indicated.

Patients who agreed to participate in the study were submitted initially to a screening
interview with the Brief Fatigue Inventory questionnaire from MD Anderson. If the patient
presented with a severe fatigue, anemia (HB<11.0), hypothyroidism or psychiatric disorders
she was excluded. If she presented with a mild or moderate fatigue the follow up continued
and the patient was assessed 21 days later after her first cycle of chemotherapy with the
same questionnaire. If an increase in fatigue levels occurred from mild to moderate, mild to
severe or moderate to severe the patient was randomly assigned to receive either Guaraná
50mg or a placebo p.o. q12 for 21 days. At this moment the patient answered a General
questionnaire, FACIT-F, FACIT-ES, HADS, Pittsburgh Sleep Quality Index and Chalder Fatigue
Questionnaire (Day 1).

After the second cycle of chemotherapy the patient underwent a "wash out" period of 7 days
without any intervention, and after that period she received placebo or Guaraná according to
the cross over design after answering for the second time the questionnaires above (Day 29)
and also the Common Terminology Criteria for Adverse Events v3.0 (CTCAE). After 21 days (Day
42) she was assessed again with the same questionnaires used in the second interview.

The patient's cancer diagnosis, treatment history, concurrent medication was recorded during
the pretreatment and The Brief Fatigue Inventory was answered before each assessment.