Are Published Cancer Care Trial Protocols With Traditional Chinese Medicine Interventions Concordant With SPIRIT-TCM Extension 2018? A Scoping Review on Published Trial Protocols Between 2019 and 2022.

BACKGROUND: The SPIRIT-TCM Extension 2018 was created to guide the design and reporting of Traditional Chinese Medicine (TCM) clinical trial protocols. This study aims to investigate the extent of concordance with this guideline in the relevant field of cancer care research. METHODS: A scoping review of TCM cancer trial protocols published in English and Chinese since January 2019 was conducted. Five major academic databases (MEDLINE, EMBASE, CINAHL, CENTRAL, and China National Knowledge Infrastructure) were searched. Concordance with the SPIRIT-TCM Extension 2018 was assessed by descriptive analysis. RESULTS: Fifty-three TCM cancer care trial protocols were identified, comprising 23 acupuncture, 26 Chinese herbal medicine (CHM), and 4 Tai Chi/Qigong (TCQ) interventions. The majority of the checklist items had a low rate of concordance, especially in the reporting of quality control and safety, dosage, TCM diagnostic patterns, possible interactions between Western Medicine and TCM interventions, and TCM-related outcome assessments. CONCLUSIONS: Although the SPIRIT-TCM Extension 2018 guideline was established through extensive Delphi consultation, there are low rates of concordance between published TCM cancer care clinical trial protocols with the guideline. Further research is necessary to understand the low rate of concordance and how scientific rigors of reporting can be improved in TCM cancer care research.

National survey on the availability of oncology palliative care services at tertiary general and cancer hospitals in China.

BACKGROUND: This nationwide survey studied the level of palliative care (PC) access for Chinese patients with cancer among cancer care providers either in tertiary general hospitals or cancer hospitals in China. METHODS: Using a probability-proportionate-to-size method, we identified local tertiary general hospitals with oncology departments to match cancer hospitals at the same geographic area. A PC program leader or a designee at each hospital reported available PC services, including staffing, inpatient and outpatient services, education, and research, with most questions adapted from a previous national survey on PC. The primary outcome was availability of a PC service. RESULTS: Most responders reported that some type of PC service (possibly called "comprehensive cancer care," "pain and symptom management," or "supportive care") was available at their institution (84.3% of tertiary general hospitals, 82.8% of cancer hospitals). However, cancer hospitals were significantly more likely than tertiary general hospitals to have a PC department or specialist (34.1% vs. 15.5%, p < 0.001). The most popular services were pain consultation (> 92%), symptom management (> 77%), comprehensive care plans (~ 60%), obtaining advanced directives and do-not-resuscitate orders (~ 45%), referrals to hospice (> 32%), and psychiatric assessment (> 25%). Cancer hospitals were also more likely than tertiary general hospitals to report having inpatient beds for PC (46.3% vs. 30.5%; p = 0.010), outpatient PC clinics (28.0% vs. 16.8%; p = 0.029), educational programs (18.2% vs. 9.0%, p = 0.014), and research programs (17.2% vs. 9.3%, p < 0.001). CONCLUSIONS: Cancer hospitals are more likely to offer PC than are tertiary general hospitals in China. Our findings highlight opportunities to further increase the PC capacity in Chinese hospitals.

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.

Cancer-Related Fatigue Outcome Measures in Integrative Oncology: Evidence for Practice and Research Recommendations.

Cancer-related fatigue (CRF) is one of the most common symptoms across the cancer continuum and is often underreported and undertreated. Defined as a distressing, persistent, subjective sense of tiredness or exhaustion related to cancer or its treatment, CRF includes physical, emotional, cognitive, and spiritual dimensions. Patient-reported outcome (PRO) measures are the most widely used tool to screen for and assess fatigue and the associated negative impacts on quality of life. However, selecting subjective CRF measures can be complex. This has resulted in the availability of and inconsistent use of numerous PROs, limiting the ability to cross-compare outcomes clinically and within research. To address this, the PROs that are most widely reported in the literature are recommended to support the standardization of a core set of validated measures. The National Comprehensive Cancer Network single-item tool for clinical significance is recommended for quick use in clinical environments; the Brief Fatigue Inventory allows for fast, easy, helpful cutoffs on severity threshold for triage, and measures both severity and interference with daily functioning; while the MD Anderson Symptom Inventory allows for multisymptomatic assessment. In addition, a fundamental consideration for any PRO use is the administrative burden on the patient and clinician. In this review, we aim to summarize current, validated PROs specific to CRF to aid clinicians and researchers in patient care and in study design and implementation. We conclude with suggestions for future directions in CRF research that can increase the possibility for long-term impact on future guidelines of fatigue management.

Patient-Reported Outcomes of Pain and Related Symptoms in Integrative Oncology Practice and Clinical Research: Evidence and Recommendations.

Pain is a primary concern among patients with cancer and cancer survivors. Integrative interventions such as acupuncture, massage, and music therapy are effective nonpharmacologic approaches for cancer pain with low cost and minimal adverse events. Patient-reported outcomes (PROs) that have been validated in many clinical and research settings can be used to evaluate pain intensity, associated symptom burden, and quality of life. Clearly defined, reliable PROs can improve patient satisfaction and symptom control. As integrative oncology continues to evolve and expand, cancer-related pain PROs must be standardized to accurately guide clinicians and researchers. Well-validated pain PROs, such as the Brief Pain Inventory, are among the most commonly used for pain intensity assessment. Multiple symptom assessment tools such as the MD Anderson Symptom Inventory, the Memorial Symptom Assessment Scale, the Edmonton Symptom Assessment System, and the Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events measurement system can also capture pain-associated symptom burden. Electronic PROs provide flexibility in collecting and analyzing PRO data. Clinical trials using carefully selected PROs and rigorous statistical analysis plans are fundamental to conducting high-quality integrative oncology research and promoting utilization of effective integrative interventions to improve patient outcomes. In this review, we aim to summarize current, validated PROs specific to cancer-related pain to aid integrative oncology clinicians and researchers in patient care and in study design and implementation.

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.

Evaluation of Traditional Chinese Medicine Herbs in Oncology Clinical Trials.

Despite wide empirical use and demand for traditional Chinese medicine (TCM) herbs worldwide, high-quality clinical trials of TCM herbs in oncology are limited. We developed recommendations for rigorous clinical trials to evaluate their safety and efficacy for oncology patients. To accomplish this goal, the TCM & Cancer Research Committee of the Chinese Pharmaceutical Association convened a working group of oncologists, TCM experts, clinical researchers, biostatisticians, and industry/government representatives to develop principles and approaches for TCM cancer drug clinical trials. They identified 2 categories of herbal drugs based on therapeutic intent: survival improvement and symptom management. The working group also emphasized the need to adopt international standards when appropriate for TCM herbal drug approval and to develop methodology to standardize diagnostic criteria, treatment approaches, and outcome measures according to defining TCM characteristics. These recommendations aim to improve study design and methods to inform rigorous investigation of TCM herbs in patients with cancer.

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.

Ren Shen Yangrong Tang for Fatigue in Cancer Survivors: A Phase I/II Open-Label Study.

OBJECTIVES: This open-label, prospective, phase I/II trial was performed to establish the safety and efficacy of Traditional Chinese Medicine (TCM) herbal products for treating non-anemia-related fatigue in patients with cancer. Although this practice is widespread in China, it has not been confirmed in a prospective clinical study. DESIGN: Thirty-three patients who had completed cancer treatment, had stable disease and no anemia, and reported moderate to severe fatigue (rated ≥4 on a 0-10 scale) were enrolled in a TCM outpatient clinic. Patients took Ren Shen Yangrong Tang (RSYRT) decoction, a soup containing 12 TCM herbs, twice a day for 6 weeks. RSYRT aims to correct qi deficiency. Fatigue was assessed before and after RSYRT therapy, which all patients completed. RESULTS: No discomfort or toxicity was observed. Before the study, all patients had had fatigue for at least 4 months. Fatigue severity decreased significantly from before therapy to 6 weeks after therapy: from 7.06 to 3.30 on a 0-10 scale (p<0.001). Fatigue category (mild, moderate, severe) shifted significantly (p=0.024): Of 22 patients with severe fatigue (rated ≥7) before therapy, 11 had mild fatigue and 11 had moderate fatigue after TCM treatment. The time-to-fatigue-alleviation was 2-3 weeks. CONCLUSION: RSYRT therapy was safe and was associated with fatigue improvement in nonanemic cancer survivors, consistent with historical TCM clinical practice experience. Because of a possible placebo effect in this open-label study, decoction RSYRT warrants further study in randomized clinical trials to confirm its effectiveness for managing moderate to severe fatigue.

Investigation of common symptoms of cancer and reliability analysis.

OBJECTIVE: To identify cancer distribution and treatment requirements, a questionnaire on cancer patients was conducted. It was our objective to validate a series of symptoms commonly used in traditional Chinese medicine (TCM). METHODS: The M. D. Anderson Symptom Assessment Inventory (MDASI) was used with 10 more TCM items added. Questions regarding TCM application requested in cancer care were also asked. A multi-center, cross-sectional study was conducted in 340 patients from 4 hospitals in Beijing and Dalian. SPSS and Excel software were adopted for statistical analysis. The questionnaire was self-evaluated with the Cronbach's alpha score. RESULTS: The most common symptoms were fatigue 89.4%, sleep disturbance 74.4%, dry mouth 72.9%, poor appetite 72.9%, and difficulty remembering 71.2%. These symptoms affected work (89.8%), mood (82.6%), and activity (76.8%), resulting in poor quality of life. Eighty percent of the patients wanted to regulate the body with TCM. Almost 100% of the patients were interested in acquiring knowledge regarding the integrated traditional Chinese medicine (TCM) and Western medicine (WM) in the treatment and rehabilitation of cancer. Cronbach's alpha score indicated that there was acceptable internal consistency within both the MDASI and TCM items, 0.86 for MDASI, 0.78 for TCM, and 0.90 for MDASI-TCM (23 items). CONCLUSIONS: Fatigue, sleep disturbance, dry mouth, poor appetite, and difficulty remembering are the most common symptoms in cancer patients. These greatly affect the quality of life for these patients. Patients expressed a strong desire for TCM holistic regulation. The MDASI and its TCM-adapted model could be a critical tool for the quantitative study of TCM symptoms.