RESUMO
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.
RESUMO
OBJECTIVE: Cat's claw (Uncaria tomentosa) is a native Amazon plant that exhibits anti-inflammatory and antitumor properties. We wanted to assess its activity for symptom management of terminal cancer patients. METHODS: This prospective phase II study assessed the effects of a 100-mg dose of a dry extract of U. tomentosa three times per day in patients with advanced solid tumors who had no further therapeutic options and a life expectancy of at least 2 months. The European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ C30) and Functional Assessment of Chronic Illness Therapy - Fatigue questionnaires were used to assess the participants' quality of life, the Hospital Anxiety and Depression Scale questionnaire was used to assess anxiety and depression, and the Pittsburgh Sleep Quality Index was used to assess sleep quality. In addition, several biochemical and inflammatory parameters were analyzed. RESULTS: Fifty-one volunteers were recruited. Their median age was 64 (range, 33-85) years, and 47% of patients were female. More than 65% of patients had scores on the Karnofsky Performance Scale of 80% or less. Treatment improved the patients' overall quality of life (p=0.0411) and social functioning (p=0.0341), as assessed by the EORTC QLQ C-30, and reduced fatigue (p=0.0496) according to the Chalder Fatigue Questionnaire. None of the biochemical or inflammatory parameters assessed (interleukin-1 and -6, C-reactive protein, tumor necrosis factor-α, erythrocyte sedimentation rate, and α-1-acid glycoprotein) changed significantly. No tumor response was detected according to the Response Evaluation Criteria In Solid Tumors; however, the disease stabilized for more than 8 months in four participants. The medication was well tolerated by most patients. CONCLUSION: Use of cat's claw might be beneficial in patients with advanced cancer by improving their quality of life and reducing fatigue. The mechanism of action does not seem to be related to the anti-inflammatory properties of this plant.
