Prevention of Depression With Escitalopram in Patients Undergoing Treatment for Head and Neck Cancer Randomized, Double-blind, Placebo-Controlled Clinical Trial

JAMA Otolaryngology - Head and Neck Surgery (Impact Factor: 1.79). 06/2013; 139(7):1-9. DOI: 10.1001/jamaoto.2013.3371
Source: PubMed


IMPORTANCE Major depressive disorder develops in up to half the patients undergoing treatment for head and neck cancer, resulting in significant morbidity; therefore, preventing depression during cancer treatment may be of great benefit. OBJECTIVE To determine whether prophylactic use of the antidepressant escitalopram oxalate would decrease the incidence of depression in patients receiving primary therapy for head and neck cancer. DESIGN, SETTING, AND PARTICIPANTS A randomized, double-blind, placebo-controlled trial of escitalopram vs placebo was conducted in a group of nondepressed patients diagnosed as having head and neck cancer who were about to enter cancer treatment. Patients were stratified by sex, site, stage (early vs advanced), and primary modality of treatment (radiation vs surgery). MAIN OUTCOME AND MEASURE The primary outcome measure was the number of participants who developed moderate or greater depression (scores on the Quick Inventory of Depressive Symptomology-Self Rated of ≥11). RESULTS From January 6, 2008, to December 28, 2011, 148 patients were randomized. Significantly fewer patients receiving escitalopram developed depression (24.6% in the placebo group vs 10.0% in the escitalopram group; stratified log-rank test, P = .04). A Cox proportional hazards regression model compared the 2 treatment groups after controlling for age, baseline smoking status, and stratification variables. The hazard ratio of 0.37 (95% CI, 0.14-0.96) demonstrated an advantage of escitalopram (P = .04). Patients undergoing radiotherapy as the initial modality were significantly more likely to develop depression than those undergoing surgery (radiotherapy compared with surgery group; hazard ratio, 3.6; 95% CI, 1.38-9.40; P = .009). Patients in the escitalopram group who completed the study and were not depressed rated their overall quality of life as significantly better for 3 consecutive months after cessation of drug use. CONCLUSIONS AND RELEVANCE In nondepressed patients undergoing treatment for head and neck cancer, prophylactic escitalopram reduced the risk of developing depression by more than 50%. In nondepressed patients who completed the trial, quality of life was also significantly better for 3 consecutive months after cessation of drug use in the escitalopram group. These findings have important implications for the treatment of patients with head and neck cancer. TRIAL REGISTRATION Identifier: NCT00536172.

9 Reads
  • [Show abstract] [Hide abstract]
    ABSTRACT: Outcomes research is defined as clinical and population-based research that investigates the results of healthcare practices or interventions through the filter of the benefit to the patient and other stakeholders. Outcomes research is an increasingly important field or research, because of the pressing need for evidence-based information that can be used to make better informed health and healthcare decisions, and define desired health care practices in the current era of healthcare reform. This article will review the head and neck cancer (HNCA) outcomes literature published in the past year, with a focus on studies evaluating treatment and survival, short-term and long-term complications, and quality of life (QOL).
    Current Oncology Reports 03/2014; 16(3):376. DOI:10.1007/s11912-013-0376-7 · 2.89 Impact Factor
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: Background: Head and neck cancer (HNC) and its treatment can affect communication, nutrition, and physical appearance, and the global impact of this disease on patients' quality of life may be substantial. Objective: The aim of this systematic literature review was to describe the impact of HNC and its treatment on the physical, emotional, and social well-being of patients over time, by examining longitudinal studies of patient-reported outcomes (PRO) evaluating these domains. Methods: Databases (MEDLINE and Embase) were searched to identify studies published in English between January 2004 and January 2014 analyzing the humanistic aspects of HNC in adult patients. Additional relevant publications were identified through manual searches of abstracts from recent conference proceedings. Results: Of 1,566 studies initially identified, 130 met the inclusion criteria and were evaluated in the assessment. Investigations using a variety of PRO instruments in heterogeneous patient populations consistently reported that PRO scores decrease significantly from diagnosis through the treatment period, but generally recover to baseline in the first year post-treatment. This trend was observed for many functional domains, although some side effects, such as xerostomia, persisted well beyond 1 year. In addition, considerable evidence exists that baseline PRO scores can predict clinical endpoints such as overall and progression-free survival. Conclusions: Many aspects of HNC, both disease and treatment specific, profoundly affect patients' quality of life. Improved knowledge of these effects on PRO may allow for more informed treatment decisions and can help physicians to better prepare patients for changes they may experience during therapy. Furthermore, the predictive value of baseline PRO data may enable healthcare providers to identify at-risk patients in need of more intensive intervention.
    PharmacoEconomics 05/2014; 32(9). DOI:10.1007/s40273-014-0169-3 · 2.45 Impact Factor
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: Depression is a distressing emotion that occurs during various times of the cancer trajectory. Depression often goes unrecognized and untreated, which can significantly affect cost, quality of life, and treatment adherence. The Oncology Nursing Society's Putting Evidence Into Practice depression project team reviewed current literature to identify evidence-based interventions to reduce depression in people with cancer. Pharmacologic and nonpharmacologic interventions were evaluated, and opportunities for nurses to integrate recommendations into practice are offered in this article.
    Clinical journal of oncology nursing 12/2014; 18:26-37. DOI:10.1188/14.CJON.S3.26-37 · 0.91 Impact Factor
Show more