Purpose This phase II component of a multi-institutional phase II/III randomized trial assessed the feasibility and preliminary efficacy of acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) in reducing radiation-induced xerostomia. Methods Head and neck cancer patients who were 3–24 months from completing radiotherapy ± chemotherapy (RT±C) and experiencing xerostomia symptoms with basal whole saliva production ≥0.1 ml/min and without recurrence were eligible. Patients received twice weekly ALTENS sessions (24 over 12 weeks) using a Codetron™ unit. The primary objective assessed the feasibility of ALTENS treatment. A patient was considered compliant if 19/24 ALTENS were delivered, with a targeted 85% compliance rate. Secondary objectives measured treatment-related toxicities and ALTENS effect on overall radiation-induced xerostomia burden using the University of Michigan Xerostomia-Related Quality of Life Scale (XeQOLS). Results Of 48 accrued patients, 47 were evaluable. Median age was 60 years; 84% were male, 70% completed RT±C for > 12 months and 21% had received prior pilocarpine. All ALTENS sessions were completed in 34 patients, but 9 and 1 completed 20–23 and 19 sessions respectively, representing a 94% total compliance rate. 6-month XeQOLS scores were available for 35 patients; 30 (86%) achieved a positive treatment response with a mean reduction of 35.9% (SD 36.1). Five patients developed grade 1–2 gastrointestinal toxicity and one had grade 1 pain event. Conclusions ALTENS treatment for radiation-induced xerostomia can be uniformly delivered in a cooperative multicenter setting and has possible beneficial treatment response. Given these results, the phase III component of this study was initiated.

BACKGROUND Brief tools are needed to screen for depressive symptoms among oncology outpatients. METHODS Patients starting radiotherapy for first diagnosis of any tumor completed distress screening tools including the Patient Health Questionnaire (PHQ-9; PHQ-2), the National Comprehensive Cancer Network-Distress Thermometer (NCCN-DT), and the Hopkins Symptom Checklist (HSCL-25). Patients exceeding validated cutoff scores and a systematic sample of patients who screened negative completed the Structured Clinical Interview for DSM-IV (SCID) Mood Disorder modules via telephone. RESULTS 463 patients from 35 community-based and 2 academic radiation oncology sites were recruited. Of 455 eligible, 66% were women (n=299) with breast (45%), GI (11%), lung (10%), gynecologic (6%), or other (27%) cancers. Seventy-five (16.5%) exceeded screening cut-offs for depressive symptoms. Of these, 42 patients completed the SCID. An additional 37 who screened negative completed the SCID. Among 79 patients completing a SCID, 8 (10.1%) met criteria for major depression, 2 (2.5%) for Dysthymia, and 6 (7.6%) for Adjustment disorder. The PHQ-2 demonstrated good psychometric properties for screening for mood disorders, using a cut-off score ≥ 3 (ROC area under the curve=0.83) and was comparable to the PHQ-9 (> 9; AUC=0.85). The NCCN-DT did not detect depression (AUC=0.59). CONCLUSION The PHQ-2 demonstrated good psychometric properties to screen for mood disorders, which were equivalent to the PHQ-9 and superior to the NCCN-DT. These findings support using the PHQ-2 to identify patients in need of further assessment for depression, a low prevalence but clinically significant comorbidity. Findings can inform implementation of distress screening accreditation standards.

Purpose The purpose of this secondary analysis was to determine change in overall Health-related Quality of Life (HRQOL) based on patient data obtained from NRG Oncology RTOG 0537 as measured by the RTOG-modified University of Washington Head and Neck Symptom Score (RM-UWHNSS). Methods A multi-site prospective randomized clinical trial design stratified 137 patients with post-radiation therapy xerostomia according to prior pilocarpine (PC) treatment and time after radiation therapy and/or chemotherapy and randomized patients into two groups. Patients were assigned to acupuncture or PC. Twenty-four sessions of acupuncture-like transcutaneous nerve stimulation (ALTENS) were administered over 12 weeks, or oral PC (5 mg) three times daily over the same 12 weeks. The RM-UWHNSS was administered at baseline and at 4, 6, 9 and 15 months after the date of randomization. Results There were no between-arm differences in change scores on the RM-UWHNSS in the individual items, total score, or factor scores. For statistical modeling, race and time were significant for all outcomes (total and factor scores), while treatment arm was not significant. The ALTENS arm showed greater yet non-significant improvement on outcomes compared to the PC arm. Conclusion Although no significant treatment differences were seen in this trial, patients receiving ALTENS consistently had lower scores, indicating better function, as compared to those receiving PC. Radiation-induced xerostomia improved over time for all patients.

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