Predicting benefit from immune checkpoint inhibitors in patients with non-small-cell lung cancer by CT-based ensemble deep learning: a retrospective study.

BACKGROUND: Only around 20-30% of patients with non-small-cell lung cancer (NCSLC) have durable benefit from immune-checkpoint inhibitors. Although tissue-based biomarkers (eg, PD-L1) are limited by suboptimal performance, tissue availability, and tumour heterogeneity, radiographic images might holistically capture the underlying cancer biology. We aimed to investigate the application of deep learning on chest CT scans to derive an imaging signature of response to immune checkpoint inhibitors and evaluate its added value in the clinical context. METHODS: In this retrospective modelling study, 976 patients with metastatic, EGFR/ALK negative NSCLC treated with immune checkpoint inhibitors at MD Anderson and Stanford were enrolled from Jan 1, 2014, to Feb 29, 2020. We built and tested an ensemble deep learning model on pretreatment CTs (Deep-CT) to predict overall survival and progression-free survival after treatment with immune checkpoint inhibitors. We also evaluated the added predictive value of the Deep-CT model in the context of existing clinicopathological and radiological metrics. FINDINGS: Our Deep-CT model demonstrated robust stratification of patient survival of the MD Anderson testing set, which was validated in the external Stanford set. The performance of the Deep-CT model remained significant on subgroup analyses stratified by PD-L1, histology, age, sex, and race. In univariate analysis, Deep-CT outperformed the conventional risk factors, including histology, smoking status, and PD-L1 expression, and remained an independent predictor after multivariate adjustment. Integrating the Deep-CT model with conventional risk factors demonstrated significantly improved prediction performance, with overall survival C-index increases from 0·70 (clinical model) to 0·75 (composite model) during testing. On the other hand, the deep learning risk scores correlated with some radiomics features, but radiomics alone could not reach the performance level of deep learning, indicating that the deep learning model effectively captured additional imaging patterns beyond known radiomics features. INTERPRETATION: This proof-of-concept study shows that automated profiling of radiographic scans through deep learning can provide orthogonal information independent of existing clinicopathological biomarkers, bringing the goal of precision immunotherapy for patients with NSCLC closer. FUNDING: National Institutes of Health, Mark Foundation Damon Runyon Foundation Physician Scientist Award, MD Anderson Strategic Initiative Development Program, MD Anderson Lung Moon Shot Program, Andrea Mugnaini, and Edward L C Smith.

A Randomized Controlled Trial of Brief Mindfulness Meditation for Women Undergoing Stereotactic Breast Biopsy.

PURPOSE: Stereotactic breast biopsy (SBB) is a common, anxiety-producing procedure. Nonpharmacologic methods to manage acute anxiety are needed. METHODS: In this single-blind trial, women were recruited before SBB and randomized in a 2:2:1 ratio to a single session of guided mindfulness-based meditation (GM; n = 30), focused breathing (FB; n = 30), or standard care (SC; n = 16). Anxiety and pain were assessed at baseline after a 10-min prebiopsy group-specific activity (GM, FB, or SC), every 4 min during SBB, and after biopsy. Electroencephalographic activity in the medial prefrontal cortex, insula, anterior cingulate cortex, and precuneus was collected throughout the study. RESULTS: Women in the GM group reported a steeper reduction in anxiety than women in the FB and SC groups (P < .001 for all, Cohen's d > 0.4 for all). There were no group differences in pain ratings during the biopsy. Women in the GM group experienced increased beta activity during biopsy in the insula (P = .006, Cohen's d = 1.4) and anterior cingulate cortex (P = .019, Cohen's d = 1.0) compared with women in the SC group, and there was a trend toward the same effect compared with women in the FB group (P < .10 for both). Women in the GM and FB groups experienced a nonsignificant decrease in delta activity in the precuneus during biopsy compared with those in the SC group (P < .40 for both, Cohen's d > 0.6 for both), which was associated with a steeper reduction in anxiety during the biopsy (r = 0.51, P < .01). CONCLUSIONS: Brief, guided meditation may provide effective anxiety relief during an acute medical procedure and affect neuronal activity in regions associated with attention, self-awareness, and emotion regulation.

A Pragmatic Evaluation of Symptom Distress After Group Meditation for Cancer Patients and Caregivers: A Preliminary Report.

CONTEXT: Complementary health approaches such as meditation may help improve cancer patient and caregiver symptoms, yet little research has examined the clinical application of these programs. OBJECTIVES: We explored the effects of a meditation group class, offered as part of an integrative medicine clinic at a comprehensive cancer center, on patient and caregiver self-reported symptoms. METHODS: Participants (patients and caregivers) of any three meditation group classes offered-Power of Breath (PB), Sacred Sounds (SS), and Movement & Breath (MB)-were asked to complete the Edmonton Symptom Assessment Scale (ESAS; scale 0-10, 10 most severe) before and after participation. ESAS individual items and subscales were analyzed; distress subscales included global (global distress score 0-90), physical (physical distress score 0-60), and psychological (psychological distress score, 0-20). Data were analyzed examining premeditation/postmeditation scores using paired t-tests and between types of meditation using analyses of variance. RESULTS: One hundred forty-two unique participants (76 patients and 66 caregivers) attended one or more meditation groups (mean 1.84) from May to December 2015 (265 total attendance: PB n = 92; SS n = 87; MB n = 86). For all participants, we observed clinically significant reduction/improvement in global distress scores (-5.17, SD 8; P < 0.0001) and in individual symptoms (ESAS decrease ≥ 1; means) of well-being (-1.36 SD 1.7; P < 0.0001), fatigue (-1.34 SD 1.9; P < 0.0001), anxiety (-1.26 SD 1.6; P < 0.001), and shortness of breath (-1.2 SD 2; P = 0.001). Comparing class length (60 vs. 90 minutes), class content (PB vs. SS vs. MB), and participants (caregivers vs. patients), there were no statistically significant differences in symptom score reduction. CONCLUSION: A single meditation group class offered as part of clinical care resulted in relief of multiple self-reported symptoms in both patients and caregivers.

Yoga Program for High-Grade Glioma Patients Undergoing Radiotherapy and Their Family Caregivers.

BACKGROUND: Despite their high symptom burden and poor prognosis, evidence-based supportive care interventions for adults with high-grade glioma (HGG) and their caregivers are lacking. Thus, we aimed to establish feasibility of a patient-caregiver dyadic yoga program (DYP) for newly diagnosed HGG patients and their family caregivers targeting quality-of-life (QOL) outcomes. METHOD: In this single-arm pilot trial, dyads participated in a 12-session DYP program across the course of patients' radiotherapy. The intervention focused on breathing exercises, gentle movements, and guided meditations. We tracked feasibility data and assessed levels of cancer-related symptoms (MD Anderson Symptom Inventory [MDASI]), depressive symptoms (Centers for Epidemiological Studies-Depression scale), fatigue (Brief Fatigue Inventory), sleep disturbances (Pittsburgh Sleep Quality Index [PSQI]), and overall mental and physical QOL (36-item Short-Form Survey [SF-36]) at baseline and post-DYP, which was at the end of radiotherapy. RESULTS: We approached 6 dyads of which 5 dyads (86%) consented and completed all 12 sessions and pre/post assessments. All patients (mean age: 52 years, 80% female, 80% grade IV) and caregivers (mean age: 58 years, 80% female, 60% spouses) perceived benefit from the program. Paired t tests revealed a marginally significant, yet clinically meaningful, decrease in patient's cancer symptoms ( t = 2.32, P = .08; MDASI mean; pre = 1.75, post = 1.04). There were clinically significant reductions in patient sleep disturbances (PSQI mean: pre = 10.75, post = 8.00) and improvements in patient and caregiver mental QOL (MCS of SF-36 mean: pre = 42.35, post = 52.34, and pre = 45.14, post = 51.43, respectively). CONCLUSIONS: This novel supportive care program appears to be safe, feasible, acceptable, and subjectively useful for HGG patients and their caregivers. There was also preliminary evidence regarding QOL treatment gains for both patients and caregivers.

Inpatient Acupuncture at a Major Cancer Center.

BACKGROUND: Use of complementary and integrative therapies is increasing among cancer patients, but data regarding the impact treatments such as acupuncture have in an inpatient oncology setting are limited. METHODS: Patients who received acupuncture in an inpatient hospital environment between December 2014 and December 2015 were asked to complete a modified Edmonton Symptom Assessment Scale (ESAS; 0-10 scale) before and after each visit. Pre- and post-treatment scores were examined for each symptom using paired t tests. RESULTS: A total of 172 inpatients were treated with acupuncture in their hospital beds (257 visits). Thirty percent (n = 51) received at least one additional follow-up treatment (mean visits/patient = 1.5). Completion rate of the modified ESAS after acupuncture was 42%. The most common reasons for not completing the post-treatment ESAS were "patient too drowsy" or "patient fell asleep" (72%). For patients who reported a baseline symptom score ≥1, the greatest improvements (mean change ± SD) after acupuncture on the initial visit were found for pain (-1.8 ± 2.2; n = 69; P < .0001), nausea (-1.2 ± 1.9; n = 30; P < .001), anxiety (-0.8 ± 1.8; n = 36; P = .01), drowsiness (-0.6 ± 1.8; n = 57; P = .02), and fatigue (-0.4 ± 1.1; n = 67; P = .008). For patients who received at least one follow-up visit, significant improvement from baseline was found for sleep disturbance (-2.5 ± 4.4; n = 17; P = .03), anxiety (-2.4 ± 1.7; n = 9; P = .002), pain (-2.3 ± 2.7; n = 20; P = .001), and drowsiness (-2.0 ± 2.6; n = 16; P = .008). CONCLUSIONS: Patients who received inpatient acupuncture at a major cancer center experienced significant improvement after treatment for pain, sleep disturbance, anxiety, drowsiness, nausea, and fatigue.

Randomized trial of Tibetan yoga in patients with breast cancer undergoing chemotherapy.

BACKGROUND: The current randomized trial examined the effects of a Tibetan yoga program (TYP) versus a stretching program (STP) and usual care (UC) on sleep and fatigue in women with breast cancer who were undergoing chemotherapy. METHODS: Women with stage (American Joint Committee on Cancer (AJCC) TNM) I to III breast cancer who were undergoing chemotherapy were randomized to TYP (74 women), STP (68 women), or UC (85 women). Participants in the TYP and STP groups participated in 4 sessions during chemotherapy, followed by 3 booster sessions over the subsequent 6 months, and were encouraged to practice at home. Self-report measures of sleep disturbances (Pittsburgh Sleep Quality Index), fatigue (Brief Fatigue Inventory), and actigraphy were collected at baseline; 1 week after treatment; and at 3, 6, and 12 months. RESULTS: There were no group differences noted in total sleep disturbances or fatigue levels over time. However, patients in the TYP group reported fewer daily disturbances 1 week after treatment compared with those in the STP (difference, -0.43; 95% confidence interval [95% CI], -0.82 to -0.04 [P = .03]) and UC (difference, -0.41; 95% CI, -0.77 to -0.05 [P = .02]) groups. Group differences at the other time points were maintained for TYP versus STP. Actigraphy data revealed greater minutes awake after sleep onset for patients in the STP group 1 week after treatment versus those in the TYP (difference, 15.36; 95% CI, 7.25-23.48 [P = .0003]) and UC (difference, 14.48; 95% CI, 7.09-21.87 [P = .0002]) groups. Patients in the TYP group who practiced at least 2 times a week during follow-up reported better Pittsburgh Sleep Quality Index and actigraphy outcomes at 3 months and 6 months after treatment compared with those who did not and better outcomes compared with those in the UC group. CONCLUSIONS: Participating in TYP during chemotherapy resulted in modest short-term benefits in sleep quality, with long-term benefits emerging over time for those who practiced TYP at least 2 times a week. Cancer 2018;124:36-45. © 2017 American Cancer Society.

Integrative Oncology Outpatient Consultations: Long-Term Effects on Patient-Reported Symptoms and Quality of Life.

Background: Integrative oncology (IO) seeks to bring non-conventional approaches into conventional oncology care in an evidence-based, coordinated manner. Little is known about the effects of such consultations on patient-reported symptoms. Methods: We reviewed data from patients referred for an IO outpatient consultation between 2009 and 2013, comparing the cohort of patients with at least one follow-up to the cohort with an initial consultation only. Assessments completed at initial and follow-up encounters included: complementary and alternative medicine (CAM) use questionnaire, Measure Yourself Concerns and Wellbeing (MYCaW), Edmonton Symptom Assessment Scale (ESAS; 10 symptoms, scale 0-10, 10 worst), and post-consultation satisfaction. ESAS individual items and global (GDS; score 0-90), physical (PHS, 0-60) and psychological (PSS, 0-20) distress scales were analyzed. Results: 642 patients out of 2,474 (26%) new patient IO consultations had at least one follow-up encounter (mean 3.2; SD 1.8). Age, place of residence, and higher satisfaction were predictors of follow-up. Statistically significant improvement in symptoms between initial consult and follow-up were observed for depression, anxiety, well-being, and subscales of GDS and PSS (all p's > 0.01). For those with moderate to severe symptoms at their initial consult (ESAS scores ≥ 4), we observed clinical response rates (improvement) of 49-75% for all ESAS symptoms at follow-up. Conclusions: Patients presenting for IO follow-up had overall mild to moderate symptoms at baseline and stable symptom burden over time. Greatest improvements were observed for psychosocial symptoms, most pronounced for the subset of patients with moderate to severe symptoms at their initial consultation.

The effects of oncology massage on symptom self-report for cancer patients and their caregivers.

BACKGROUND: Massage has shown benefit for symptomatic relief in cancer patients and their caregivers. We explored the effects of a single massage session on self-reported symptoms in an outpatient clinic at a comprehensive cancer center. METHODS: Patients and caregivers receiving oncology massage treatments (30 or 60-min duration) at our Integrative Medicine Center outpatient clinic from September 2012 to January 2015 completed the Edmonton Symptom Assessment Scale (ESAS; 0-10 scale, 10 most severe) pre and post massage. ESAS individual items and subscales of physical distress (PHS), psychological distress (PSS), and global distress (GDS) were analyzed. We used paired t tests with a p value correction (i.e., p < .001) to examine symptoms pre/post massage. RESULTS: Initial massage visits for 343 patients and 87 caregivers were analyzed. The highest symptom burdens (means) at baseline for patients were sleep 4.22, fatigue 3.57, and pain 2.94; for caregivers, sleep 3.77, well-being 3.01, and pain 2.59. Although patients reported significantly greater global distress and physical symptoms (p < .0001) compared to caregivers at baseline, groups did not differ in regard to psychological symptom burden (p = .66) and individual symptom scores (e.g., pain, sleep, spiritual pain). Massage therapy was associated with statistically (p < .0001) and clinically significant improvements in symptoms of pain, fatigue, anxiety, well-being, and sleep and ESAS subscales for both patients and caregivers. Greater massage duration (30 vs 60 min) did not lead to greater symptom reduction. CONCLUSIONS: Patients and caregivers reported a moderately high symptom burden. A single massage treatment resulted in acute relief of self-reported symptoms in both groups. Further study is warranted regarding optimal massage dose and frequency.

Integrative Oncology Physician Consultations at a Comprehensive Cancer Center: Analysis of Demographic, Clinical and Patient Reported Outcomes.

Background: Integrative oncology (IO) is a relatively new field that seeks to bring evidence-based, non-conventional approaches into conventional oncology care in a coordinated and safe manner. Though complementary and alternative medicine (CAM) are highly utilized by cancer patients, little is known about the characteristics of patients seeking IO consultation. Methods: Patients presenting for an outpatient IO consultation completed a CAM use questionnaire, Measure Yourself Concerns and Wellbeing (MYCaW), Edmonton Symptom Assessment Scale (ESAS), Quality of Life Short Form 12 (SF-12), and post-consultation satisfaction item. Results: 2,474 new patient IO consultations were conducted from 9/2009 to 12/2013 and 2367 (96%) completed at least one measure. Most were female (69%); the most frequent cancer type was breast (29%); 38% had distant/advanced disease; 75% had used a CAM approach in prior 12 months. The most common concerns were seeking an integrative/holistic approach (34%), herbs/supplements (34%), and diet/nutrition (21%). Overall symptom burden was low, with baseline symptom scores (ESAS) highest (worst) for sleep (4.2; SD 2.8), fatigue (4.0; SD 2.8), and well-being (3.8; SD 2.6). On the SF-12, the physical health scores (35.3; SD 7.5) were significantly lower than that of a healthy population (50), but mental health scores were not (46.8; SD 10.2). Satisfaction was high (9.4; SD 1.3) with the consultation. Conclusions: Patients presenting for IO consultation tended to have early stage disease, had previously used a CAM approach, had a relatively low symptom burden, and were most interested in developing an integrative approach to their care or discussing herbs/supplement use.

A Comprehensive Lifestyle Randomized Clinical Trial: Design and Initial Patient Experience.

BACKGROUND: Although epidemiological research demonstrates that there is an association between lifestyle factors and risk of breast cancer recurrence, progression of disease, and mortality, no comprehensive lifestyle change clinical trials have been conducted to determine if changing multiple risk factors leads to changes in biobehavioral processes and clinical outcomes in women with breast cancer. This article describes the design, feasibility, adherence to the intervention and data collection, and patient experience of a comprehensive lifestyle change clinical trial (CompLife). METHODS: CompLife is a randomized, controlled trial of a multiple-behavior intervention focusing on diet, exercise, and mind-body practice along with behavioral counseling to support change. The initial exposure to the intervention takes place during the 4 to 6 weeks of radiotherapy (XRT) for women with stage III breast cancer and then across the subsequent 12 months. The intervention group will have 42 hours of in-person lifestyle counseling during XRT (7-10 hours a week) followed by up to 30 hours of counseling via video connection for the subsequent 12 months (weekly sessions for 6 months and then monthly for 6 months). The primary outcome is disease-free survival. Multiple secondary outcomes are being evaluated, including: (1) biological pathways; (2) overall survival; (3) patient-reported outcomes; (4) dietary patterns/fitness levels, anthropometrics, and body composition; and (5) economic outcomes. Qualitative data of the patient experience in the trial is collected from exit interviews, concluding remarks, direct email correspondences, and web postings from patients. RESULTS: Fifty-five patients have been recruited and randomized to the trial to date. Accrual of eligible patients is high (72%) and dropout rates extremely low (5%). Attendance to the in-person sessions is high (95% attending greater than 80% of sessions) as well as to the 30 hours of video counseling (88% attending more than 70% of sessions). Adherence to components of the behavior change intervention is high and compliance with the intensive amount of data collection is exceptional. Qualitative data collected from the participants reveals testimonials supporting the importance of the comprehensive nature of intervention, especially the mind-body/mindfulness component and social support, and meaningful lifestyle transformations. CONCLUSION: Conducting a comprehensive, multicomponent, lifestyle change clinical trial for women with breast was feasible and collection of biobehavioral outcomes successful. Adherence to behavior change was high and patient experience was overwhelmingly positive.

Qigong/tai chi for sleep and fatigue in prostate cancer patients undergoing radiotherapy: a randomized controlled trial.

OBJECTIVES: Sleep disturbances and fatigue are common in prostate cancer patients undergoing radiotherapy. Prior research suggests mind-body techniques may improve these outcomes. We conducted a randomized controlled trial of qigong/tai chi (QGTC) in men with prostate cancer undergoing radiotherapy. METHODS: Men with prostate cancer starting definitive radiation were randomized to 1 of 3 groups: (1) QGTC; (2) light exercise (LE); or (3) waiting list control. Sleep disturbances (Pittsburgh Sleep Quality Index) and fatigue (Brief Fatigue Inventory) were assessed at baseline, midway through radiotherapy (T2), during the last week of radiotherapy (T3), and at 1 (T4) and 3 months (T5) after the end of radiotherapy. Patients in the QGTC and LE groups attended three 40-minute classes per week throughout radiotherapy. RESULTS: Ninety patients were randomized to the 3 groups (QGTC = 26; LE = 26; waiting list control = 24). The QGTC group reported longer sleep duration midway through radiotherapy (QGTC = 7.01 h; LE = 6.42; WL = 6.50; P = .05), but this difference did not persist over time. There were no group differences in other domains of sleep or fatigue. Exploratory analyses conducted to examine the effect of health-related quality of life (Expanded Prostate Cancer Index Composite and American Urological Association Symptom score) on sleep and fatigue showed significant correlations across multiple domains. CONCLUSIONS: Qigong/tai chi during radiation for prostate cancer resulted in superior sleep duration midway through radiation, but this effect was not durable, and there were no differences in other domains of sleep or fatigue. Exploratory analysis demonstrated that both sleep and fatigue were highly correlated with prostate cancer-related physical symptoms. Future mind-body intervention studies should incorporate multimodal therapy focused on improving physical symptoms in this population.

Examining Mediators and Moderators of Yoga for Women With Breast Cancer Undergoing Radiotherapy.

Hypothesis This study examines moderators and mediators of a yoga intervention targeting quality-of-life (QOL) outcomes in women with breast cancer receiving radiotherapy.Methods Women undergoing 6 weeks of radiotherapy were randomized to a yoga (YG; n = 53) or stretching (ST; n = 56) intervention or a waitlist control group (WL; n = 54). Depressive symptoms and sleep disturbances were measured at baseline. Mediator (posttraumatic stress symptoms, benefit finding, and cortisol slope) and outcome (36-item Short Form [SF]-36 mental and physical component scales [MCS and PCS]) variables were assessed at baseline, end-of-treatment, and 1-, 3-, and 6-months posttreatment. Results Baseline depressive symptoms (P = .03) and sleep disturbances (P < .01) moderated the Group × Time effect on MCS, but not PCS. Women with high baseline depressive symptoms in YG reported marginally higher 3-month MCS than their counterparts in WL (P = .11). Women with high baseline sleep disturbances in YG reported higher 3-months MCS than their counterparts in WL (P < .01) and higher 6-month MCS than their counterparts in ST (P = .01). YG led to greater benefit finding than ST and WL across the follow-up (P = .01). Three-month benefit finding partially mediated the effect of YG on 6-month PCS. Posttraumatic stress symptoms and cortisol slope did not mediate treatment effect on QOL. Conclusion Yoga may provide the greatest mental-health-related QOL benefits for those experiencing pre-radiotherapy sleep disturbance and depressive symptoms. Yoga may improve physical-health-related QOL by increasing ability to find benefit in the cancer experience.

Vivekananda Yoga Program for Patients With Advanced Lung Cancer and Their Family Caregivers.

BACKGROUND: The primary purpose of this study was to establish the feasibility of a couple-based Vivekananda Yoga (VKC) intervention in lung cancer patients and caregivers. Secondly, we examined preliminary efficacy regarding quality of life (QOL) outcomes. METHOD: In this single-arm feasibility trial, patients with lung cancer undergoing radiotherapy and their caregivers participated in a 15-session VKC program that focused on the interconnectedness of the dyad. We assessed pre-and post-intervention levels of fatigue, sleep disturbances, psychological distress, overall QOL, spirituality, and relational closeness. We tracked feasibility data, and participants completed program evaluations. RESULTS: We approached 28 eligible dyads of which 15 (53%) consented and 9 (60%) completed the intervention. Patients (mean age = 73 years, 63% female, all stage III) and caregivers (mean age = 62 years, 38% female, 63% spouses) completed a mean of 10 sessions and 95.5% of them rated the program as very useful. Paired t tests revealed a significant increase in patients' mental health (d = 0.84; P = .04) and a significant decrease in caregivers' sleep disturbances (d = 1.44; P = .02). Although not statistically significant, for patients, effect sizes for change scores were medium for benefit finding and small for distress (d = 0.65 and 0.37, respectively). For caregivers, medium effects were found for improvement in physical functioning (d = 0.50). CONCLUSION: This novel supportive care program appears to be safe, feasible, acceptable, and subjectively useful for lung cancer patients and their caregivers and lends support for further study.

Randomized, placebo-controlled trial of K1 acupoint acustimulation to prevent cisplatin-induced or oxaliplatin-induced nausea.

BACKGROUND: Greater than 70% of patients with cancer experience chemotherapy-induced nausea and vomiting. In the current study, the authors examined the effects of electrostimulation of the K1 acupoint located on the sole of the foot because it is believed to have the potential to control chemotherapy-induced nausea and vomiting. METHODS: In this trial, 103 patients diagnosed with primary or metastatic liver cancer were recruited before transcatheter arterial infusion (TAI) of cisplatin or oxaliplatin and randomized to either group A (51 patients who were treated with the antiemetic tropisetron and acustimulation at the K1 acupoint for 20 minutes approximately 1 to 2 hours before TAI on the first day and then daily for the subsequent 5 days) or group B (52 patients who were treated with tropisetron and electrostimulation at a placebo point on the heel). The rate, intensity, and duration of nausea and vomiting were collected at baseline and then daily for 5 days after TAI. Quality of life was assessed daily using the MD Anderson Symptom Inventory and the EuroQoL scale. RESULTS: No differences were found between groups A and B with regard to the incidence and degree of nausea or vomiting on day 1 or the following 5 days. Patients in group A had better EuroQoL scores compared with patients in group B (72.83 in group A vs 65.94 in group B; P =.04) on day 4 but not on the other days. No group differences were noted at any time point for MD Anderson Symptom Inventory scores. CONCLUSIONS: Electrostimulation of K1 combined with antiemetics did not result in initial prevention of cisplatin-induced or oxaliplatin-induced nausea or vomiting.

Randomized, controlled trial of yoga in women with breast cancer undergoing radiotherapy.

PURPOSE: Previous research incorporating yoga (YG) into radiotherapy (XRT) for women with breast cancer finds improved quality of life (QOL). However, shortcomings in this research limit the findings. PATIENTS AND METHODS: Patients with stages 0 to III breast cancer were recruited before starting XRT and were randomly assigned to YG (n = 53) or stretching (ST; n = 56) three times a week for 6 weeks during XRT or waitlist (WL; n = 54) control. Self-report measures of QOL (Medical Outcomes Study 36-item short-form survey; primary outcomes), fatigue, depression, and sleep quality, and five saliva samples per day for 3 consecutive days were collected at baseline, end of treatment, and 1, 3, and 6 months later. RESULTS: The YG group had significantly greater increases in physical component scale scores compared with the WL group at 1 and 3 months after XRT (P = .01 and P = .01). At 1, 3, and 6 months, the YG group had greater increases in physical functioning compared with both ST and WL groups (P < .05), with ST and WL differences at only 3 months (P < .02). The group differences were similar for general health reports. By the end of XRT, the YG and ST groups also had a reduction in fatigue (P < .05). There were no group differences for mental health and sleep quality. Cortisol slope was steepest for the YG group compared with the ST and WL groups at the end (P = .023 and P = .008) and 1 month after XRT (P = .05 and P = .04). CONCLUSION: YG improved QOL and physiological changes associated with XRT beyond the benefits of simple ST exercises, and these benefits appear to have long-term durability.

Sham-controlled, randomised, feasibility trial of acupuncture for prevention of radiation-induced xerostomia among patients with nasopharyngeal carcinoma.

BACKGROUND: Xerostomia (dry mouth) after head/neck radiation is a common problem among cancer patients. Quality of life (QOL) is impaired, and available treatments are of little benefit. This trial determined the feasibility of conducting a sham-controlled trial of acupuncture and whether acupuncture could prevent xerostomia among head/neck patients undergoing radiotherapy. METHODS: A sham controlled, feasibility trial was conducted at Fudan University Shanghai Cancer Center, Shanghai, China among patients with nasopharyngeal carcinoma undergoing radiotherapy. To determine feasibility of a sham procedure, 23 patients were randomised to real acupuncture (N=11) or to sham acupuncture (N=12). Patients were treated three times/week during the course of radiotherapy. Subjective measures were the Xerostomia Questionnaire (XQ) and MD Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN). Objective measures were unstimulated whole salivary flow rates (UWSFR) and stimulated salivary flow rates (SSFR). Patients were followed for 1 month after radiotherapy. RESULTS: XQ scores for acupuncture were significantly lower than sham controls starting in week 3 and lasted through the 1-month follow-up (all P's <0.001 except for week 3, which was 0.006), with clinically significant differences as follows: week 6 - RR 0.28 [95% confidence interval, 0.10, 0.79]; week 11 - RR 0.17 [95%CI, 0.03, 1.07]. Similar findings were seen for MDASI-HN scores and MDASI-Intrusion scores. Group differences for UWSFR and SSFR were not found. CONCLUSIONS: In this small pilot study, true acupuncture given concurrently with radiotherapy significantly reduced xerostomia symptoms and improved QOL when compared with sham acupuncture. Large-scale, multi-centre, randomised and placebo-controlled trials are now needed.

Randomized controlled trial of acupuncture for prevention of radiation-induced xerostomia among patients with nasopharyngeal carcinoma.

BACKGROUND: Xerostomia (dry mouth) after head/neck radiation is a common problem among cancer patients, and available treatments are of little benefit. The objective of this trial was to determine whether acupuncture can prevent xerostomia among head/neck patients undergoing radiotherapy. METHODS: A randomized, controlled trial among patients with nasopharyngeal carcinoma was conducted comparing acupuncture to standard care. Participants were treated at Fudan University Shanghai Cancer Center, Shanghai, China. Forty patients were randomized to acupuncture treatment and 46 to standard care. Patients were treated 3×/wk on the same days they received radiotherapy. Subjective measures included the Xerostomia Questionnaire and MD Anderson Symptom Inventory-Head and Neck (MDASI-HN). Objective measures were unstimulated and stimulated whole salivary flow rates. Patients were followed for 6 months after the end of radiotherapy. RESULTS: Xerostomia Questionnaire scores for acupuncture were statistically significantly lower than for controls starting in week 3 through the 6 months (P = .003 at week 3, all other P < .0001), with clinically significant differences as follows: week 11, relative risk (RR) 0.63 (95% confidence interval [CI], 0.45-0.87); 6 months, RR 0.38 (95% CI, 0.19-0.76). Similar findings were seen for MDASI-HN scores. Group differences emerged as early as 3 weeks into treatment for saliva (unstimulated whole salivary flow rate, P = .0004), with greater saliva flow in the acupuncture group at week 7 (unstimulated whole salivary flow rate, P < .0001; stimulated whole salivary flow rate, P = .002) and 11 (unstimulated whole salivary flow rate, P < .02; stimulated whole salivary flow rate, P < .03) and at 6 months (stimulated whole salivary flow rate, P < .003). CONCLUSIONS: Acupuncture given concurrently with radiotherapy significantly reduced xerostomia and improved quality of life.