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

ABSTRACT

Fatigue 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 and the fourth evaluations of each domain in each group were compared. Regarding the FACT-HN35 questionnaire, the guarana group showed improvement after the first cycle of chemoradiotherapy with respect to pain (p = 0.0133), social eating (p = 0.0227), swallowing (p = 0.0254), coughing (p = 0.0107), and weight loss (p = 0.012); however, after treatment completion (after the third cycle) weight loss worsened (p = 0.0074) and greater use of a nasogastric tube (p = 0.051), in addition to increased use of analgesics (p = 0.0253), was observed in the guarana group. Regarding the EORTC-QOL C30 questionnaire, improvement of symptoms in the three domains (functional, overall, and symptoms) was observed in patients using guarana. No significant difference was observed between the groups regarding toxicity as graded by the Common Terminology Criteria for Adverse Events (CTCAE) scale. Conclusion: We propose that guarana is not beneficial for this patient population.

KEYWORDS. :

• chemoradiotherapy
• fatigue
• neoplasms
• quality of life