Placebo-Controlled, Double-Blind, Randomized Study of a Dry Guarana Extract in Patients with Head and Neck Tumors Undergoing Chemoradiotherapy: Effects on Fatigue and Quality of Life

ABSTRACTFatigue is a common symptom in patients with head and neck carcinoma who undergo chemoradiotherapy. Guarana (Paullinia cupana) is a plant that grows in the Brazilian Amazon region that was used previously to treat fatigue induced by chemotherapy. Methods: In this phase II prospective study, we evaluated 60 patients with stage I–IV head and neck squamous cell carcinoma before, during, and after chemoradiotherapy. The patients were randomized into two arms: placebo versus guarana at a dose of 50 mg twice a day during the chemoradiotherapy treatment. We used the FACT-HN, EORTC-HN35, and EORTC-Q30 questionnaires to assess fatigue and quality of life (QOL). Results: A significant worsening of QOL in the overall (p = 0.0054), functional (p = 0.018), and symptom (p = 0.0042) domains after the second cycle of chemotherapy was observed in patients using guarana compared to the placebo group. No significant differences in any QOL domain for either the guarana or placebo group were observed when the first an...