Compound Kushen Injection Reduces Severe Toxicity and Symptom Burden Associated With Curative Radiotherapy in Patients With Lung Cancer.

BACKGROUND: Radiotherapy (RT) causes adverse events for which there are no effective treatments. This study investigated the clinical benefits of compound Kushen injection (CKI) in managing radiation injury in patients with lung cancer. METHODS: A multicenter, open-label, randomized clinical trial randomly assigned patients with lung cancer to receive either CKI (20 mL/d for at least 4 weeks) integrated with curative RT (RT + CKI group; n=130) or RT alone (control group; n=130). The primary outcome was the incidence of grade ≥2 radiation-induced lung injury (RILI) in the lungs, esophagus, or heart. Secondary outcomes included patient-reported symptoms, quality of life, objective response rate (ORR), and toxic effects. RESULTS: During the 16-week trial, the RT + CKI group had a significantly lower incidence of grade ≥2 RT-related injury than the control group (12.3% [n=16] vs 23.1% [n=30]; P=.02). Compared with the control group, the RT + CKI group experienced a significant decrease in moderate-to-severe symptoms of fatigue, cough, and pain (P<.001 for the treatment and time interaction term); significantly less physical symptom interference (P=.01); and significantly better quality of life by the end of the trial (P<.05). No statistically significant difference in ORR was found. Adverse reactions associated with CKI were rare. CONCLUSIONS: This study demonstrated low toxicity of CKI and its effectiveness in patients with lung cancer in reducing the incidence of grade ≥2 RILI and symptom burden, improving patients' quality of life.

Cloud platform to improve efficiency and coverage of asynchronous multidisciplinary team meetings for patients with digestive tract cancer.

Background: Multidisciplinary team (MDT) meetings are the gold standard of cancer treatment. However, the limited participation of multiple medical experts and the low frequency of MDT meetings reduce the efficiency and coverage rate of MDTs. Herein, we retrospectively report the results of an asynchronous MDT based on a cloud platform (cMDT) to improve the efficiency and coverage rate of MDT meetings for digestive tract cancer. Methods: The participants and cMDT processes associated with digestive tract cancer were discussed using a cloud platform. Software programming and cMDT test runs were subsequently conducted to further improve the software and processing. cMDT for digestive tract cancer was officially launched in June 2019. The doctor response duration, cMDT time, MDT coverage rate, National Comprehensive Cancer Network guidelines compliance rate for patients with stage III rectal cancer, and uniformity rate of medical experts' opinions were collected. Results: The final cMDT software and processes used were determined. Among the 7462 digestive tract cancer patients, 3143 (control group) were diagnosed between March 2016 and February 2019, and 4319 (cMDT group) were diagnosed between June 2019 and May 2022. The average number of doctors participating in each cMDT was 3.26 ± 0.88. The average doctor response time was 27.21 ± 20.40 hours, and the average duration of cMDT was 7.68 ± 1.47 min. The coverage rates were 47.85% (1504/3143) and 79.99% (3455/4319) in the control and cMDT groups, respectively. The National Comprehensive Cancer Network guidelines compliance rates for stage III rectal cancer patients were 68.42% and 90.55% in the control and cMDT groups, respectively. The uniformity rate of medical experts' opinions was 89.75% (3101/3455), and 8.97% (310/3455) of patients needed online discussion through WeChat; only 1.28% (44/3455) of patients needed face-to-face discussion with the cMDT group members. Conclusion: A cMDT can increase the coverage rate of MDTs and the compliance rate with National Comprehensive Cancer Network guidelines for stage III rectal cancer. The uniformity rate of the medical experts' opinions was high in the cMDT group, and it reduced contact between medical experts during the COVID-19 pandemic.

A measure for perioperative anxiety symptoms in patients with FUAS - treated uterine fibroids: development and validation.

OBJECTIVE: To develop a scale that measured the perioperative anxiety symptoms of uterine fibroids (PASM-UF) treated with focused ultrasound ablation surgery (FUAS). METHODS: A panel of gynecologists, nurses, and patient-reported outcome (PRO) experts created a draft of the PASM-UF scale. Women who underwent FUAS for uterine fibroids were recruited for its psychometric validation. Assessments were conducted during admission, before surgery, and at discharge. The Symptom Checklist-90 (SCL-90) was administered to assess criterion validity. We assessed the relationship between the developed PASM-UF and the SCL-90 via a correlation analysis. Cronbach's alpha was used to assess internal consistency for reliability. RESULTS: We included five items, pain, lack of appetite, fatigue (tiredness), disturbed sleep, and anxiety, in the final version of the PASM-UF. Data were collected from 228 patients. Cronbach's alpha was 0.745, whereas the correlation coefficient between SCL-90 and PASM-UF was 0.345 (p < 0.001). The total PASM-UF scores were significantly higher in patients whose SCL-90 scores were ≥160 compared to those with <160 (9.85 ± 9.07 vs. 4.01 ± 5.15, p = .002). Those who did not complete the SCL-90 reported lower PASM-UF scores than those who did (2.33 ± 3.27 vs. 4.67 ± 5.99, p = .006). Patients reported significantly lower PASM-UF scores postoperatively than preoperatively (2.95 ± 4.18 vs. 3.92 ± 4.90, p = .002). CONCLUSIONS: The PASM-UF is a valid, reliable, and sensitive scale for assessing perioperative anxiety levels among women with uterine fibroids. Statistical analysis suggests that it is also an effective instrument for scientific research.Key MessageWe developed a brief scale to assess anxiety in perioperative patients with uterine fibroids. In addition, the scale monitored the anxiety levels at multiple frequencies and did not increase burden on the patients. The scale has been proven to be effective, reliable, and highly sensitive.

A Phase II Randomized Controlled Trial of Renshen Yangrong Tang Herbal Extract Granules for Fatigue Reduction in Cancer Survivors.

CONTEXT: Based on the traditional Chinese medicine theory, Renshen Yangrong Tang (RSYRT), which is a mixture of 12 herbs, was commonly used as a pharmacological option in China for fatigue management by correcting Qi deficiency. OBJECTIVES: This randomized controlled Phase II trial investigated the efficacy of RSYRT for reducing cancer-related fatigue. METHODS: Cancer survivors with moderate or severe fatigue (rated ≥4 on a 0-10 scale) for more than two months were randomized to take herbal extract granules of RSYRT or a low dose of a single herb (huangqi) twice a day for six weeks. Patient-reported fatigue was measured using the MD Anderson Symptom Inventory. Efficacy of RSYRT was evaluated using mixed model to test the differences over time among groups. We also conducted responder analyses and examined time to effect of symptom reduction. RESULTS: None of the 83 evaluable patients (control group 42; intervention group 41) had discomfort or Grade 3 or 4 toxicity. We observed a significantly greater MD Anderson Symptom Inventory-fatigue score reduction in the intervention group than that in the control group (time-by-group interaction: estimate = -0.61 [0.10]; P < 0.0001). More patients in the intervention group had a two-point reduction on fatigue than that of the control group (90.2% vs. 52.4%). By Week 4, between-group differences of fatigue reduction on mean severity reached large effect size (intervention group vs. control group: -2.66 vs. -1.36; Cohen's d = 1.0; P < 0.0001). CONCLUSION: Compared with control therapy, RSYRT therapy elicits a statistical and clinical improvement of fatigue severity and functioning. The effectiveness of RSYRT in managing cancer-related fatigue warrants further study in the real world.

Prevalence of functional dependence in Chinese centenarians and its relationship with serum vitamin D status.

BACKGROUND: Functional dependence (FD) and vitamin D deficiency are common conditions in older adults. However, little is known about the relationship between FD and serum vitamin D status in centenarians. The current study was designed to evaluate the prevalence of FD and examine its relationship with serum vitamin D status among centenarians in China. SUBJECTS AND METHODS: A cross-sectional study of a large sample of Chinese centenarians including 180 men and 822 women was conducted from June 2014 to December 2016. Home interviews, physical examinations, and blood analyses were performed in 958 centenarians following standard procedures. FD was evaluated using the Barthel index of activities of daily living (ADL). Serum 25-hydroxyvitamin D (25OHD) concentrations were measured as a marker of vitamin D status. RESULTS: The prevalence of centenarians with FD was 71.2%. Vitamin D deficiency, lack of tea consumption, lack of outdoor activities, visual impairment, and fracture were predictors of FD. Centenarians in the lowest quartile of serum 25OHD concentration had an approximately threefold greater likelihood of FD than those in the highest quartile in multiple logistic regression models (OR =2.88; 95% CI 1.75-4.73; P<0.001). The multivariable OR with a 1 ng/mL decrease in serum 25OHD concentration was 1.06 (95% CI 1.04-1.08; P<0.001) for FD. CONCLUSION: Serum 25OHD levels have important associations with FD in Chinese centenarians. Future research could focus on the value of intervening in the case of low serum 25OHD levels through vitamin D supplementation and improving ADL in the older population.

Validation and Application of the MD Anderson Symptom Inventory for Traditional Chinese Medicine (MDASI-TCM).

Background: The MD Anderson Symptom Inventory (MDASI) is a brief, yet thorough, patient-reported outcomes measure for assessing the severity of common cancer-related symptoms and their interference with daily functioning. We report the development of an MDASI version tailored for use with Traditional Chinese Medicine in China (the MDASI-TCM). Methods: Chinese-speaking patients with mixed cancer types (n = 317) participated in the study. The development and validation process included four steps: 1) identify candidate TCM-specific items, with input from patients, oncologists, and TCM specialists; 2) eliminate candidate TCM items lacking relevance, based on patient report; 3) psychometrically examine the MDASI-TCM's validity and reliability in cancer patients receiving TCM-based care; and 4) cognitively debrief patients to assess the MDASI-TCM's relevance, understandability, and acceptability. Results: Seven TCM-specific symptom items (sweating, feeling cold, constipation, bitter taste, coughing, palpitations, and heat in palms/soles) were clinically and psychometrically meaningful to add to the core MDASI. Approximately 61% of patients had moderate to severe symptoms (rated ≥5 on the MDASI-TCM's 0-10 scale). Cronbach α coefficients were .90 for symptom-severity items and .93 for interference items, indicating internal consistency reliability. Known-group validity was substantiated by the MDASI-TCM's detection of differences in symptom severity according to performance status (P < .001) and interference levels by cancer stage (P < .05). Cognitive debriefing indicated that patients found the MDASI-TCM to be an understandable, easy-to-use tool. Conclusions: The Chinese MDASI-TCM is a valid, reliable, and concise measure of symptom severity and interference that can be used to assess Chinese cancer patients and survivors receiving TCM-based care.