EFFECTIVENESS OF GUARANÁ (PAULLINIA CUPANA) FOR MANAGEMENT OF FATIGUE IN WOMEN WITH BREAST CANCER UNDERGOING CHEMOTHERAPY: PLACEBO-CONTROLLED CLINICAL TRIAL

Marcela D. Albarnaz, Dalete D. C. F. Mota, Maria M. Bachion

Universidade Federal de GoiásOBJECTIVE: Assess the effectiveness of guarana (Paullinia cupana) 50 mg administered twice daily in the management of fatigue in women with breast cancer undergoing chemotherapy. METHODS: Randomized, double blind, placebo-controlled, clinical trial realized in a Hospital at Goiás. Fatigued women undergoing chemotherapy were randomly distributed in two groups: guarana group (GG/ n=21) and placebo group (PG/ n=21). Assessment was performed on baseline, 45 and 90 days after the baseline evaluation. The mean total and dimensional (behavioral, affective and sensory/cognition/emotional) scores of Revised-Piper Fatigue Scale were used. Analysis of variance with Greenhouse-Geiser correction measured the treatment effect in each group and Bonferroni post hoc analysis was conducted. Student’s t-test was used for comparison of mean fatigue scores. Multiple linear regression assessed the intergroup effect. The square Eta was used to measure the effect size. Bivariate and multivariate negative binomial regression with robust variance were used to measure the effect of treatment on fatigue rates (p <0.05). RESULTS: Intragroup analysis revealed significant reduction on fatigue’s mean total in 1.32 scores, and all dimensional scores in GG group. No differences were noted in the PG. Inter-group analysis showed significant difference between the two groups for total and dimensional scores after 90 days of treatment. The size of the oral intake effect of 50mg of guarana dry extract twice daily on total fatigue and all dimensions were considered moderate. Multivariate analyses revealed reduction on fatigue rate in 63% in GG group. None occurrence of grade 2, 3 or 4 toxicities were recorded in this study. CONCLUSIONS: Guarana has shown to be effective on treating fatigue (total and dimensional scores) in women with breast cancer undergoing chemotherapy, after 90 days of treatment. Fatigue; Breast Cancer; Guarana; Oncology.