OBJECTIVES/HYPOTHESIS: To evaluate the safety and potential efficacy of autologous muscle-derived cells (AMDCs) for the treatment of swallowing impairment following treatment for oropharynx cancer.
STUDY DESIGN: Prospective, phase I, open label, clinical trial.
METHODS: Oropharynx cancer survivors disease free ≥2 years post chemoradiation were recruited. All patients had swallowing impairment but were not feeding tube dependent (Functional Oral Intake Scale [FOIS] ≥ 5). Muscle tissue (50-250 mg) was harvested from the vastus lateralis and 150 × 106 AMDCs were prepared (Cook MyoSite Inc., Pittsburgh, PA). The cells were injected into four sites throughout the intrinsic tongue musculature. Participants were followed for 24 months. The primary outcome measure was safety. Secondary endpoints included objective measures on swallowing fluoroscopy, oral and pharyngeal pressure, and changes in patient-reported outcomes.
RESULTS: Ten individuals were enrolled. 100% (10/10) were male. The mean age of the cohort was 65 (±8.87) years. No serious adverse event occurred. Mean tongue pressure increased significantly from 26.3 (±11.1) to 31.8 (±9.5) kPa (P = .017). The mean penetration-aspiration scale did not significantly change from 5.6 (±2.1) to 6.8 (±1.8), and the mean FOIS did not significantly change from 5.4 (±0.5) to 4.6 (±0.7). The incidence of pneumonia was 30% (3/10) and only 10% (1/10) experienced deterioration in swallowing function throughout 2 years of follow-up. The mean eating assessment tool (EAT-10) did not significantly change from 24.1 (±5.57) to 21.3 (±6.3) (P = .12).
CONCLUSION: Results of this phase I clinical trial demonstrate that injection of 150 × 106 AMDCs into the tongue is safe and may improve tongue strength, which is durable at 2 years. A blinded placebo-controlled trial is warranted.
LEVEL OF EVIDENCE: 3 Laryngoscope, 132:523-527, 2022.
Introduction: A recent randomized controlled trial (RCT) in patients with head and neck cancer (HNC) with psychological distress showed that a stepped care (SC) program targeting psychological distress compared with care as usual (CAU), is (cost)effective in reducing psychological distress. Aim: The aim of the present study was to investigate whether SC can coalleviate problems with sexual interest and enjoyment. A secondary aim was to investigate whether the presence of an unmet sexual health need and having a psychiatric disorder (depression or anxiety) at baseline moderated any effect of SC on these sexual variables until 1-year follow-up. Methods: HNC survivors (N = 134), randomized to SC or CAU, were assessed regarding their sexual interest and enjoyment before and after the intervention and at 3, 6, 9, and 12 months follow-up. Linear mixed models were used to evaluate differences in the course of sexual interest and enjoyment between SC and CAU. Main Outcome Measure: The “sexuality” symptom subscale, part of the European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire, Head and Neck Cancer–specific module. Results: Of all patients, 76.1% had an unmet sexual need at baseline, 24.6% had a psychiatric disorder (anxiety or depression). SC did not reduce problems with sexual interest and enjoyment at any of the follow-up measurements compared with CAU (P =.85). This was neither moderated by an unmet sexual health need at baseline (P =.64) nor by the presence of a psychiatric disorder at baseline (P =.59). Conclusion: A substantial number of patients with HNC have unmet sexual health needs. SC targeting psychological distress does not reduce problems with sexuality in these patients. Interventions specifically targeting sexuality are recommended. LER Schutte, HC Melissant, F Jansen, et al. Effect of Stepped Care on Sexual Interest and Enjoyment in Distressed Patients with Head and Neck Cancer: A Randomized Controlled Trial. Sex Med 2021;9:100304.
BACKGROUND: To identify predictors of carotid artery stenosis (CAS) progression in head and neck cancer (HNC) patients after radiation therapy (RT).
METHODS: We included 217 stroke-naïve HNC patients with mild carotid artery stenosis after RT in our hospital. These patients underwent annual carotid duplex ultrasound (CDU) studies to monitor CAS progression. CAS progression was defined as the presence of ≥50% stenosis of the internal/common carotid artery on follow-up CDU. We recorded total plaque score (TPS) and determined the cut-off TPS to predict CAS progression. We categorized patients into high (HP) and low plaque (LP) score groups based on their TPS at enrolment. We analyzed the cumulative events of CAS progression in the two groups.
RESULTS: The TPS of the CDU study at enrolment was a significant predictor for CAS progression (adjusted odds ratio [aOR] = 1.69, p = 0.002). The cut-off TPS was 7 (area under the curve: 0.800), and a TPS ≥ 7 strongly predicted upcoming CAS progression (aOR = 41.106, p = 0.002). The HP group had a higher risk of CAS progression during follow-up (adjusted hazard ratio = 6.15; 95% confident interval: 2.29-16.53) in multivariable Cox analysis, and also a higher trend of upcoming ischemic stroke (HP vs. LP: 8.3% vs. 2.2%, p = 0.09).
CONCLUSIONS: HNC patients with a TPS ≥ 7 in any CDU study after RT are susceptible to CAS progression and should receive close monitoring within the following 2 years.
Trismus is a common symptom in patients with head and neck cancer that affects many aspects of daily life negatively. The aim of this study was to investigate the impact of structured exercise with the jaw-mobilizing device TheraBite on trismus, trismus-related symptomatology, and health-related quality of life (HRQL) in patients with head and neck cancer. Fifteen patients with trismus (maximum interincisal opening [MIO] ≤35 mm) after oncologic treatment for head and neck cancer, underwent a 10-week exercise program with the TheraBite device and were followed regularly. Time between oncologic treatment and start of TheraBite exercise ranged from 0.7 to 14.8 years (average 6.2 years). MIO, trismus-related symptoms, and HRQL was assessed before and after exercise and after 6 months. A significant improvement in MIO was observed post-exercise (3.5 mm, 15.3%, p = 0.0002) and after 6-month of follow-up (4.7 mm, 22.1%, p = 0.0029). A statistically significant correlation was found between increased MIO and fewer trismus-related symptoms. In conclusion, exercise with TheraBite improved MIO and trismus-related symptoms in patients with trismus secondary to head and neck cancer. Structured exercise with the jaw-mobilizing device seems to be beneficial for patients with trismus independent of time since oncologic treatment.
BACKGROUND: Self-management regimens for oral and oropharyngeal cancer survivors can be complex and challenging. Effective self-management skills can foster better outcomes. We report on the development, feasibility, and pilot testing of a web-based self-management tool called "Empowered Survivor" (ES) for survivors of oral and oropharyngeal cancer.
METHODS: ES content was developed in two phases, with modules focusing on oral care, swallowing and muscle strength, and long-term follow-up. This single-arm pilot study consisted of a pre-, 2-month, and a 6-month postintervention survey.
RESULTS: Enrollment rates were relatively low. Once enrolled, data collected from the ES website indicated that 81.8% viewed ES. Participants provided positive evaluations of ES. Preliminary results indicate that ES had a beneficial impact on self-management self-efficacy, preparedness for survivorship care, and quality of life. ES improved survivors' engagement in oral self-exams and head and neck strengthening exercises, improved ability to address barriers, and decreased information and support needs.
CONCLUSIONS: This study provides preliminary evidence of engagement, acceptability, and beneficial impact of ES, which should be evaluated in a larger controlled clinical trial.
OBJECTIVE: To investigate the effectiveness of a guided self-help exercise program on swallowing, speech, and shoulder problems in patients treated with total laryngectomy (TL).
MATERIALS AND METHODS: This randomized controlled trial included patients treated with TL in the last 5 years. Patients were randomized into the intervention group (self-help exercise program with flexibility, range-of-motion and lymphedema exercises and self-care education program) or control group (self-care education program). Both groups completed measurements before and 3 and 6-months after randomization. The primary outcome was swallowing problems (SWAL-QOL). Secondary outcomes were speech problems (SHI), shoulder problems (SDQ), self-management (patient activation: PAM) and health-related quality of life (HRQOL: EORTC QLQ-C30/H&N35). Adherence was defined as moderate-high in case a patient exercised >1 per day. Linear mixed model analyses were conducted to investigate the effectiveness of the intervention and to investigate whether neck dissection, treatment indication (primary/salvage TL), time since treatment, severity of problems, and preferred format (online/booklet) moderated the effectiveness.
RESULTS: Moderate-high adherence to the exercise program was 59%. The intervention group (n = 46) reported less swallowing and communication problems over time compared to the control group (n = 46) (p-value = 0.013 and 0.004). No difference was found on speech, shoulder problems, patient activation and HRQOL. Time since treatment moderated the effectiveness on speech problems (p-value = 0.025): patients within 6 months after surgery benefitted most from the intervention. Being treated with a neck dissection, treatment indication, severity of problems and format did not moderate the effectiveness.
CONCLUSION: The guided self-help exercise program improves swallowing and communication.
TRIAL REGISTRATION: NTR5255.
PURPOSE: Fatigue is a distressing symptom in head & neck cancer patients before during and at the end of curative therapy. Pharmacologic and not pharmacologic treatments have been proposed with scarce or no evidence of efficacy. The aim of the study is to evaluate the efficacy of American ginseng in respect to placebo in reducing fatigue in patients treated for head and neck cancer with curative intent.
METHODS: Thirty-two patients who had completed oncological treatment for a primary Head & neck tumor for at least 1 year and had a global fatigue score > 4 by means of Brief Fatigue Inventory (BFI) were randomized to receive 1000 mg of American ginseng or placebo per day for 8 weeks with the aim to assess their efficacy. Changes in fatigue scores in the 2 subgroups of patients before and after the treatment with American ginseng or placebo, were assessed by the BFI at baseline and at the end of week 8.
RESULTS: The mean of the mean values of the BFI measured at 8 weeks (end of treatment) was 4.6 in the Ginseng arm and 3.4 in the Placebo arm (p = ns). Mean comparison showed a tendency to statistical significance only for the single item on interference with general activity (p = 0.06), with better performance for placebo. The mean of the differences between baseline values and 8 weeks values was not significantly different between treatment arms considering the entire questionnaire.
CONCLUSION: The present data shows that American ginseng has insufficient evidence to be recommended for Cancer Related Fatigue (CRF) in post treatment HNC survivors.
Esophageal squamous cell neoplasms (ESCNs) are the most common second primary neoplasm in patients with head and neck squamous cell carcinoma (HNSCC), and few studies have focused on metachronous ESCNs. We aimed to evaluate the incidence of and risk factors for metachronous ESCNs and to provide a reasonable endoscopic follow-up plan for HNSCC patients. We extended our prospective cohort since October 2008 by recruiting incident HNSCC patients. All enrolled patients were interviewed to collect information on substance use (smoking, alcohol, and betel nut) and esophagogastroduodenoscopy (EGD) with Lugol chromoendoscopy results for synchronous ESCNs soon after HNSCC diagnosis. Endoscopic screenings for metachronous ESCNs were performed 6 to 12 months after the previous examinations. A total of 1042 incident HNSCC patients were enrolled, but only 175 patients met all the criteria and were analyzed. A total of 20 patients had metachronous ESCNs (20/175, 11.4%). Only the initial Lugol-voiding lesion (LVL) classification significantly predicted the development of metachronous ESCNs. Patients with an LVL classification of C/D had a higher risk of developing metachronous ESCNs than those with an LVL classification of A/B (adjusted odds ratio: 5.03, 95% confidence interval: 1.52-16.67). The mean interval for developing metachronous ESCNs was 33 months, but the shortest interval for developing metachronous esophageal squamous cell carcinoma was 12 months. Lugol chromoendoscopy screening among incident HNSCC patients predicts the risk of developing metachronous ESCNs. A closer follow-up with an endoscopy every 6 months is recommended for those with LVL classifications of C and D.
To evaluate the safety and potential efficacy of autologous muscle-derived cells (AMDCs) for the treatment of swallowing impairment following treatment for oropharynx cancer.
STUDY DESIGN:
Prospective, phase I, open label, clinical trial.
METHODS:
Oropharynx cancer survivors disease free ≥2 years post chemoradiation were recruited. All patients had swallowing impairment but were not feeding tube dependent (Functional Oral Intake Scale [FOIS] ≥ 5). Muscle tissue (50-250 mg) was harvested from the vastus lateralis and 150 × 106 AMDCs were prepared (Cook MyoSite Inc., Pittsburgh, PA). The cells were injected into four sites throughout the intrinsic tongue musculature. Participants were followed for 24 months. The primary outcome measure was safety. Secondary endpoints included objective measures on swallowing fluoroscopy, oral and pharyngeal pressure, and changes in patient-reported outcomes.
RESULTS:
Ten individuals were enrolled. 100% (10/10) were male. The mean age of the cohort was 65 (±8.87) years. No serious adverse event occurred. Mean tongue pressure increased significantly from 26.3 (±11.1) to 31.8 (±9.5) kPa (P = .017). The mean penetration-aspiration scale did not significantly change from 5.6 (±2.1) to 6.8 (±1.8), and the mean FOIS did not significantly change from 5.4 (±0.5) to 4.6 (±0.7). The incidence of pneumonia was 30% (3/10) and only 10% (1/10) experienced deterioration in swallowing function throughout 2 years of follow-up. The mean eating assessment tool (EAT-10) did not significantly change from 24.1 (±5.57) to 21.3 (±6.3) (P = .12).
CONCLUSION:
Results of this phase I clinical trial demonstrate that injection of 150 × 106 AMDCs into the tongue is safe and may improve tongue strength, which is durable at 2 years. A blinded placebo-controlled trial is warranted.
