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Carlos J. Roldan, Matthew Chung, Lei Feng, and Eduardo Bruera

Background: Oral mucositis is a complication of cancer therapy, causing severe pain that affects oral functioning, nutrition, and quality of life, as well as therapy nonadherence or dose-limiting toxicity. Anecdotal experience has suggested that methylene blue (MB) oral rinse may be an effective and safe treatment of this oral pain. Methods: To evaluate the efficacy and safety of MB oral rinse for the treatment of oral pain due to mucositis in patients with cancer, we retrospectively evaluated patients who experienced refractory pain despite conventional therapy. Results: We identified 281 patients who received MB oral rinse. Most were receiving treatment for leukemia (n=85; 30.3%) and head and neck squamous cell carcinoma (n=84; 29.9%). The most common treatments were radiation therapy alone (n=108; 38.4%) and chemoradiation (n=86; 30.6%). Median duration of symptoms was 14 days. Mean (SD) numeric rating scale pain scores were 7.7 (1.83; median, 8) before MB oral rinse and 2.51 (2.76; median, 2) after MB oral rinse (P<.0001). Most patients achieved pain control within the first 3 doses. The effectiveness of MB oral rinse was independent of patient age, sex, cancer type, cancer stage, MB dilution, and pain duration or baseline pain scores. The lowest response to treatment was reported in individuals with esophageal mucositis. Few patients experienced adverse effects of MB oral rinse (n=13; 4.6%); 10 had a transient burning sensation, 2 had transient blue discoloration of the teeth and mouth, and 1 had increased pain. Conclusions: MB oral rinse is an effective and safe treatment for refractory pain from oral mucositis related to cancer treatment.

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Alyssa A. Schatz, Thomas K. Oliver, Robert A. Swarm, Judith A. Paice, Deepika S. Darbari, Deborah Dowell, Salimah H. Meghani, Katy Winckworth-Prejsnar, Eduardo Bruera, Robert M. Plovnick, Lisa Richardson, Neha Vapiwala, Dana Wollins, Clifford A. Hudis, and Robert W. Carlson

Opioids are a critical component of pain relief strategies for the management of patients with cancer and sickle cell disease. The escalation of opioid addiction and overdose in the United States has led to increased scrutiny of opioid prescribing practices. Multiple reports have revealed that regulatory and coverage policies, intended to curb inappropriate opioid use, have created significant barriers for many patients. The Centers for Disease Control and Prevention, National Comprehensive Cancer Network, and American Society of Clinical Oncology each publish clinical practice guidelines for the management of chronic pain. A recent JAMA Oncology article highlighted perceived variability in recommendations among these guidelines. In response, leadership from guideline organizations, government representatives, and authors of the original article met to discuss challenges and solutions. The meeting featured remarks by the Commissioner of Food and Drugs, presentations on each clinical practice guideline, an overview of the pain management needs of patients with sickle cell disease, an overview of perceived differences among guidelines, and a discussion of differences and commonalities among the guidelines. The meeting revealed that although each guideline varies in the intended patient population, target audience, and methodology, there is no disagreement among recommendations when applied to the appropriate patient and clinical situation. It was determined that clarification and education are needed regarding the intent, patient population, and scope of each clinical practice guideline, rather than harmonization of guideline recommendations. Clinical practice guidelines can serve as a resource for policymakers and payers to inform policy and coverage determinations.

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Michael H. Levy, Anthony Back, Costantino Benedetti, J. Andrew Billings, Susan Block, Barry Boston, Eduardo Bruera, Sydney Dy, Catherine Eberle, Kathleen M. Foley, Sloan Beth Karver, Sara J. Knight, Sumathi Misra, Christine S. Ritchie, David Spiegel, Linda Sutton, Susan Urba, Jamie H. Von Roenn, and Sharon M. Weinstein

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Sriram Yennurajalingam, Nizar M. Tannir, Janet L. Williams, Zhanni Lu, Kenneth R. Hess, Susan Frisbee-Hume, Helen L. House, Zita Dubauskas Lim, Kyu-Hyoung Lim, Gabriel Lopez, Akhila Reddy, Ahsan Azhar, Angelique Wong, Sunil M. Patel, Deborah A. Kuban, Ahmed Omar Kaseb, Lorenzo Cohen, and Eduardo Bruera

Background: Despite the high frequency, severity, and effects of cancer-related fatigue (CRF) on the quality of life (QoL) of patients with cancer, limited treatment options are available. The primary objective of this study was to compare the effects of oral Panax ginseng extract (PG) and placebo on CRF. Secondary objectives were to determine the effects of PG on QoL, mood, and function. Methods: In this randomized, double-blind, placebo-controlled study, patients with CRF ≥4/10 on the Edmonton Symptom Assessment System (ESAS) were eligible. Based on a pilot study, we randomized patients to receive either 400 mg of standardized PG twice daily or a matching placebo for 28 days. The primary end point was change in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) subscale from baseline to day 29. Results: Of 127 patients, 112 (88.2%) were evaluable. The mean (SD) FACIT-F subscale scores at baseline, day 15, and day 29 were 22.4 (10.1), 29.9 (10.6), and 30.1 (11.6) for PG (P<.001), and 24.0 (9.4), 30.0 (10.1), and 30.4 (11.5) for placebo (P<.001). Mean (SD) improvement in the FACIT-F subscale at day 29 was not significantly different in the PG than in the placebo group (7.5 [12.7] vs 6.5 [9.9]; P=.67). QoL, anxiety, depression, symptoms, and functional scores were not significantly different between the PG and placebo groups. Improvement in the FACIT-F subscale correlated with baseline scores (P=.0005), Hospital Anxiety and Depression Scale results (P=.032), and sex (P=.023). There were fewer any-grade toxicities in the PG versus placebo group (28/63 vs 33/64; P=.024). Conclusions: Both PG and placebo result in significant improvement in CRF. PG was not significantly superior to placebo after 4 weeks of treatment. There is no justification to recommend the use of PG for CRF. Further studies are needed. Trial Registration: ClinicalTrials.gov identifier: NCT01375114.