dos Santos Martins, S.P., Ferreira, C.L., & del Giglio, A. (2017). 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. Journal of Dietary Supplements, 14, 32–41.

To determine if the use of guarana extract affects fatigue or quality of life in patients with head and neck cancer undergoing chemoradiotherapy

Patients were randomized to receive either guarana or placebo, with both given twice daily before meals for six weeks while they were undergoing chemoradiotherapy. The patients receiving guarana took 50 mg twice daily. The patients were assessed three times throughout treatment at day 1, day 21, and day 42, and once three weeks after the completion of treatment on day 63. The three assessments during treatment corresponded with cisplatin administration. Each assessment included fatigue and quality of life questionnaires, evaluation for guarana toxicity according to the World Health Organization scale, as well as weight and renal function.

• N = 52   
• AGE = Not specified
• MALES (%): Not specified, FEMALES (%): Not specified
• CURRENT TREATMENT: Combination radiation and chemotherapy
• KEY DISEASE CHARACTERISTICS: Stage I–IV head and neck cancer, mainly squamous cell carcinoma. Patients underwent 30 sessions of radiotherapy and three cycles of cisplatin.

• SITE: Not stated/unknown   
• SETTING TYPE: Not specified    
• LOCATION: Brazil

PHASE OF CARE: Active antitumor treatment

Phase II, placebo-controlled, double-blind, randomized study

• General questionnaire
• Guarana Toxicity Assessment 
• Functional Assessment of Cancer Therapy-Fatigue (FACT-F)
• Functional Assessment of Cancer Therapy-Head and Neck (FACIT-HN), version 4.0
• European Organization of Research and Treatment of Cancer Core Quality of Life (EORTC QLQ-30) questionnaire
• EORTC QLQ-H&N-35 questionnaire

No statistically significant reduction in fatigue or improvement in quality of life was identified in either group using any questionnaire. Some initial or transient improvements were noted but were not statistically significant or did not last the length of treatment. The authors do not recommend the use of guarana in this patient population.

This intervention was not successful for this patient population. Although the authors reported some positive benefits, based upon the description of the results, it is unclear if this is related to the guarana or other factors that could influence quality of life in the patient population.

• Small sample (< 100)
• Measurement/methods not well described
• Subject withdrawals ≥ 10%

In terms of nursing practice, this study highlights the significance of malnutrition, weight loss, and mucositis in this patient population, and addressing these complications of chemotherapy and radiation in this patient population seems like a promising area for nursing attention and research.