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ImportanceAlthough 1 in 4 head and neck cancer (HNC) survivors experience clinically significant body image distress (BID), a psychosocial morbidity that adversely affects quality of life, effective interventions for these patients are lacking.ObjectiveTo evaluate the acceptability and preliminary efficacy of BRIGHT (Building a Renewed ImaGe after Head and neck cancer Treatment), a brief tele–cognitive behavioral therapy, at reducing BID among HNC survivors.Design, Setting, and ParticipantsThis parallel-group pilot randomized clinical trial recruited adult HNC survivors with BID between August 13, 2020, and December 9, 2021, from the Medical University of South Carolina HNC clinic during a routine survivorship encounter. Data were analyzed from May 3 to June 16, 2022.InterventionsBRIGHT consisted of 5 weekly psychologist-led video tele–cognitive behavioral therapy sessions. Attention control (AC) consisted of dose- and delivery-matched survivorship education.Main Outcomes and MeasuresChange in HNC-related BID was assessed using IMAGE-HN (Inventory to Measure and Assess imaGe disturbancE–Head and Neck), a validated patient-reported outcome (score range, 0-84, with higher scores indicating greater HNC-related BID). Clinical response rate was measured as the proportion of patients with a clinically meaningful change in IMAGE-HN scores.ResultsOf the 44 HNC survivors with BID allocated to BRIGHT (n = 20) or AC (n = 24), the median (range) age was 63 (41-80) years, and 27 patients (61%) were female. Patients rated BRIGHT’s acceptability highly (all metrics had a mean rating of ≥4.5/5), and 19 of 20 patients (95%) receiving BRIGHT were likely or highly likely to recommend it to other HNC survivors with BID. BRIGHT decreased HNC-related BID from baseline to 1 month postintervention relative to AC (mean model-based difference in change in IMAGE-HN score, –7.9 points; 90% CI, –15.9 to 0.0 points) and from baseline to 3 months postintervention relative to AC (mean model-based difference in change in IMAGE-HN score, –17.1 points; 90% CI, −25.6 to −8.6 points). At 3 months postintervention, the clinical response rate of BRIGHT was 6.6-fold higher than AC (model-based odds ratio, 6.6; 90% CI, 2.0-21.8). The improvement in HNC-related BID for BRIGHT vs AC at 3 months was clinically significant, and the effect size was large (Cohen d, −0.9; 90% CI, −1.4 to −0.4).Conclusions and RelevanceIn this pilot randomized clinical trial, BRIGHT was acceptable, may result in a clinically meaningful improvement in HNC-related BID, and showed a high clinical response rate. These promising preliminary data support conducting a large efficacy trial to establish BRIGHT as the first evidence-based treatment for HNC survivors with BID.Trial RegistrationClinicalTrials.gov Identifier: NCT03831100

Importance The American Joint Committee on Cancer staging system (Cancer Staging Manual, 8th Edition) for head and neck squamous cell carcinoma (HNSCC) now categorizes human papillomavirus (HPV)–negative HNSCC in a single positive lymph node smaller than 3 cm with pathologic extranodal extension (ENE) as N2a. The standard of care for pathologic ENE is adjuvant chemoradiation therapy (CRT). Whether adding chemotherapy concurrent with adjuvant radiation therapy improves survival in this clinical scenario is unknown. Objective To assess whether adjuvant CRT relative to radiation therapy alone is associated with improved survival among patients with pN2a HPV-negative HNSCC with ENE. Design, Setting, and Participants This retrospective cohort study included 504 patients with pN2a HPV-negative HNSCC with ENE who had undergone margin-negative surgery and adjuvant therapy. The patients were identified from the National Cancer Database from January 1, 2004, to December 31, 2015. Statistical analyses were conducted from September 1, 2019, to April 16, 2020. Main Outcomes and Measures The primary end point was overall survival. The association of adjuvant CRT with overall survival was analyzed using univariate and multivariate Cox proportional hazards regression analyses. Planned subset analyses were conducted in patients younger than 70 years with no comorbidities (the subset most likely to be eligible for a clinical trial of cisplatin-based chemoradiation) and in patients with pT3/T4 disease classification. Results Of 504 patients (mean [SD] age, 60.5 [12.7] years; 319 [63.3%] men; 434 [86.1%] White) with pN2a HPV-negative HNSCC with ENE who had undergone margin-negative surgery and adjuvant therapy, 298 patients (59.1%) received adjuvant CRT. For the overall cohort of patients with pN2a ENE, adjuvant CRT was not associated with improved overall survival relative to adjuvant radiation therapy alone in a multivariate analysis (adjusted hazard ratio, 0.98; 95% CI, 0.74-1.30). Adjuvant CRT was still not associated with improved overall survival in a subset analysis of 304 patients younger than 70 years with no comorbidities (adjusted hazard ratio, 0.98; 95% CI, 0.66-1.45) nor in a subset of 220 patients with pT3/T4 disease classification (adjusted hazard ratio, 1.03; 95% CI, 0.70-1.54). Conclusions and Relevance This study found that for patients with pN2a HPV-negative HNSCC with ENE who underwent margin-negative surgery and adjuvant therapy, adding chemotherapy concurrent with adjuvant radiation therapy was not associated with improved overall survival. Additional research is necessary to identify the optimal treatment paradigm for this clinical scenario.

Importance Preservation of endolymphatic fluids, maintenance of a fluid-filled vestibule, and preservation of the cochlear nerve and its vasculature are believed to be necessary to retaining hearing after an inner-ear operation. However, some studies have reported no hearing loss despite the violation of the vestibule, questioning the importance of maintaining a fluid-filled vestibule in preserving hearing. Objective To report on the preservation of hearing after a complete labyrinthectomy for Meniere disease and after disruption of the vestibule. Evidence Review This systematic review adhered to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) reporting guidelines. A search of PubMed, Scopus, Ovid, and Cochrane Library databases was conducted to identify English-language articles on hearing preservation after labyrinthectomy, published from 1947 through December 11, 2019. The search strategy used a combination of boolean operators and included the following Medical Subject Heading terms and keywords: hearing preservation, labyrinth surgery, labyrinthectomy, vestibule violation, vestibule disruption, translabyrinthine approach, schwannoma removal, and semicircular canal ablation. Studies that included disruption of the vestibule and hearing preservation were included. Findings This systematic review identified 10 studies with 10 patients who underwent surgical removal of cholesteatoma or vestibular schwannoma and displayed postoperative hearing preservation. This study also reported on 1 patient with Meniere disease who retained hearing after undergoing a complete labyrinthectomy. Among these 11 patients, the mean (range) age was 45.1 (27-55) years, and 8 patients (73%) were women. Multiple theories exist that explain the mechanism behind hearing preservation, such as sealing of the ductus reuniens or closure of the remaining vestibule. Conclusions and Relevance This systematic review describes a set of patients who did not experience hearing loss after a labyrinthectomy or surgical violation of the vestibule, which seems to contradict prevailing principles for retaining hearing after inner-ear surgical procedures. This finding suggests that hearing preservation is possible after labyrinthine destruction despite the absence of a fluid-filled vestibule and that other mechanisms, such as occlusion of the ductus reuniens with granulation tissue or bone dust, may be sufficient to achieve that outcome.