Music Nursing as Complementary Therapy Improves Anxiety, Fatigue, and Quality of Life in Children with Acute Leukaemia: A Retrospective Study.

OBJECTIVE: To explore the effects of music nursing as a complementary therapy on anxiety, fatigue, and quality of life in children with acute leukemia (AL). METHODS: This study included 150 children with AL admitted to our hospital from August 2021 to August 2023 and divided them into two groups based on treatment: the control (n = 76, received routine nursing) and observation (n = 74, received music nursing on the basis of routine nursing) groups. Comparison of groups was performed in terms of general information, anxiety, fatigue, and quality of life at admission (T0) and 1 month after admission (T1). RESULTS: No significant differences were observed in the general data between the two groups (P > 0.05). Anxiety, fatigue, and quality of life of the two groups also showed no significant differences at T0 (P > 0.05). The observation group showed significantly lower anxiety than the control group at T1 (P < 0.05). At T1, the observation group exhibited a lower fatigue degree compared with the control group (P < 0.05). At T1, the observation group attained higher scores on physiological and emotional dimensions of the quality of life compared with the control group, and the differences were statistically significant (P < 0.05). CONCLUSION: Music nursing for AL children, which has a certain clinical application value, can effectively reduce their anxiety and fatigue and improve their quality of life.

Racial and ethnic associations with comprehensive cancer center access and clinical trial enrollment for acute leukemia.

BACKGROUND: Clinical trial participation at Comprehensive Cancer Centers (CCC) is inequitable for minoritized racial and ethnic groups with acute leukemia. CCCs care for a high proportion of adults with acute leukemia. It is unclear if participation inequities are due to CCC access, post-access enrollment, or both. METHODS: We conducted a retrospective cohort study of adults with acute leukemia (2010-2019) residing within Massachusetts, the designated catchment area of the Dana-Farber/Harvard Cancer Center (DF/HCC). Individuals were categorized as non-Hispanic Asian (NHA), Black (NHB), White (NHW), Hispanic White (HW), or Other. Decomposition analyses assessed covariate contributions to disparities in (1) access to DF/HCC care and (2) post-access enrollment. RESULTS: Of 3698 individuals with acute leukemia, 85.9% were NHW, 4.5% HW, 4.3% NHB, 3.7% NHA, and 1.3% Other. Access was lower for HW (age- and sex-adjusted OR = 0.64, 95% CI = 0.45 to 0.90) and reduced post-access enrollment for HW (aOR = 0.54, 95% CI =0.34 to 0.86) and NHB (aOR = 0.60, 95% CI = 0.39 to 0.92) compared to NHW. Payor and socioeconomic status (SES) accounted for 25.2% and 21.2% of the +1.1% absolute difference in HW access. Marital status and SES accounted for 8.0% and 7.0% of the -8.8% absolute disparity in HW enrollment; 76.4% of the disparity was unexplained. SES and marital status accounted for 8.2% and 7.1% of the -9.1% absolute disparity in NHB enrollment; 73.0% of the disparity was unexplained. CONCLUSIONS: A substantial proportion of racial and ethnic inequities in acute leukemia trial enrollment at CCCs are from post-access enrollment, the majority of which was not explained by sociodemographic factors.

Effectiveness of Group Spiritual Care on Leukemia Patients' Hope and Anxiety in Iran: A Randomized Controlled Trial.

This study examined the effectiveness of a group spiritual care program on leukemia patients' hope and anxiety. This randomized controlled trial involved 94 leukemia patients hospitalized in the two oncology departments of Shahid Beheshti Hospital, Hamadan, Iran. This study was carried out from November 2022 to April 2023. The participants were selected based on the study inclusion criteria using the convenience sampling method then they were randomized to either the experimental (N = 46) or the control group (N = 48). The participants completed the written informed consent form, the demographic information form, and Beck's anxiety and Snyder's hope questionnaires. The spiritual care program was provided in six sessions (one 45-60 min per week), including a spiritual needs assessment, religious care, spiritual care, psychological-spiritual care, supportive-spiritual care, and evaluation. The participants then completed Beck's anxiety and Snyder's hope questionnaires immediately, one and two months after the intervention. At baseline, there was no significant between-group difference in leukemia patients' mean scores of hope (P = 0.313) and anxiety (P = 0.141); however, immediately, one and two months after the intervention, a significant between-group difference in the mean scores of hope and anxiety was observed (P < 0.001). Also, from baseline to two months after the intervention, a significant decrease and increase in anxiety and hope mean scores, respectively, were observed in the experimental group (within-group difference) (P < 0.001). However, in the control group, from baseline to two months after the intervention, a significant increase and decrease in mean scores of anxiety and hope, respectively, were observed (within-group difference) (P < 0.001). As a result, it is recommended that nurses should consider providing spiritual care to leukemia patients as a part of holistic care.

The effectiveness of play therapy in children with leukemia: A systematic review.

PROBLEM: Leukemia is the most common form of childhood cancer worldwide. Children living with leukemia experience various problems because of the disease's progression, harmful effects of treatment, and prolonged hospitalization process. To increase their well-being and alleviate their problems, these children require ongoing support. One solution that both parents and professionals can use is play therapy. This systematic review aimed to identify the type and effectiveness of play therapy in children living with leukemia. ELIGIBILITY CRITERIA: We searched PubMed, Scopus, ScienceDirect, and ProQuest databases. Additionally, we performed manual searches on Google Scholar, Google Web, and grey literature. Inclusion criteria comprised: 1) Studies that implemented play therapy on leukemia children, 2) Full-text articles available in English or Indonesian languages from January 2000 to December 2021 and updated until July 2023, and 3) Intervention studies employing quasi-experimental or randomized controlled trial (RCT) designs. SAMPLE: From 1099 articles, 16 studies were selected. Several forms of play therapy were found, including pretend, music, art, and sand play therapy. RESULTS: Of the sixteen studies in this systematic review, fifteen demonstrated beneficial effects on psychological issues, particularly anxiety, despair, stress, and physical problems (fatigue and pain). CONCLUSION: Play therapy effectively alleviates some physical and psychosocial problems in children living with leukemia. IMPLICATION: Nurses can utilize play therapy as an intervention for children living with leukemia. Additionally, comparative research is recommended with a similar research strategy concerning studies with the same design. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42022318549.

The effects of music therapy on peripherally inserted central catheter in hospitalized children with leukemia.

To explore the effect of music therapy on children with leukemia who have peripherally inserted central catheters (PICC).In this study, we divided 107 patients undergoing PICC into music group (47 cases) and control group (60 cases). The music group received music therapy during PICC, while the control group was given no complementary treatment. The total length of catheterization, the use of sedatives and the changes of pain level and emotion level before and after PICC placement were compared between two groups.Compared with the control group, the total PICC placement time of the music group was significantly shorter (35(30-40) vs. 60(60-60); Z = -8.307; p < 0.001), and the use of sedative medications was also significantly reduced (4.35% (n = 2) vs. 91.84% (n = 45); p < 0.001). Moreover, the pain of catheterization was significantly alleviated. The median difference of pain scores of the music group was significantly less (2(1-3) vs. 5(5-5); p < 0.001). The mood of patients was also improved. The median difference of emotional scores of the music group was significantly more (5(4.75-6) vs. 3(3-3); p < 0.001) than the control group.Music therapy is effective to use in PICC. It can shorten the treatment time, reduce the use of sedative medications, and improve the children's emotion and pain response significantly, which is worth clinical application.

Inequities in Alliance Acute Leukemia Clinical Trial and Biobank Participation: Defining Targets for Intervention.

PURPOSE: Representativeness in acute leukemia clinical research is essential for achieving health equity. The National Cancer Institute's mandate for Comprehensive Cancer Centers (CCCs) to define and assume responsibility for cancer control and treatment across a geographic catchment area provides an enforceable mechanism to target and potentially remediate participatory inequities. METHODS: We examined enrollee characteristics across 15 Cancer and Leukemia Group B/Alliance cooperative group adult acute leukemia clinical trials (N = 3,734) from 1998 to 2013, including participation in optional companion biobanks. We determined enrollment odds by race-ethnicity for all participants adjusted for national incidence, and for those enrolled at CCCs adjusted for catchment area incidence. We modeled biobank participation by sociodemographics using logistic regression. RESULTS: Non-Hispanic (NH)-White patients were more likely to be enrolled than NH-Black, NH-Asian, or Hispanic patients (odds ratio [OR], 0.75, 0.48, and 0.44, respectively; all P < .001), but less likely than NH-Native American patients (OR, 1.91; P < .001), adjusted for national incidence. Enrollment odds were lower for NH-Black, NH-Asian, and Hispanic patients at CCCs adjusted for catchment area incidence (OR, 0.57, 0.26, and 0.32, respectively; P < .001); differences were driven by overenrollment of NH-White patients from outside self-defined catchment areas (18.1% v 12.3%; χ2 P = .01) and by CCCs with less absolute enrollee diversity (rank sum P = .03). Among all enrollees, NH-White race-ethnicity and lower neighborhood deprivation correlated with biobank participation (OR, 1.81 and 1.45, respectively; P = .01 and .03). For CCC enrollees, the correlation of race-ethnicity with biobank participation was attenuated by a measure accounting for their site's degree of enrollment disparity but not neighborhood deprivation. CONCLUSION: Acute leukemia clinical research disparities are substantial and driven by structural trial enrollment barriers at CCCs. Real-time CCC access and enrollment monitoring is needed to better align research participation with local populations.

Nursing Care Plan and Management of Patients With Acute Leukemia.

OBJECTIVE: To provide an overview of the integration of nursing care services for patients with acute leukemia in the past, present and future. DATA SOURCES: Published literature as indexed in Medline, relevant guideline documents, textbooks and clinical experience. CONCLUSION: Patients with acute leukemia have significant nursing care demands that are frequently unmet by routine oncology treatment. The initial introduction of expert nursing care into routine oncology treatment boosts patient-centered results in people with advanced solid tumors, according to research. Recent data suggest that patients with hematologic malignancies who have undergone transplantation of stem cells have similarly improved, and further trials are being conducted to assess nursing care treatments in patients with acute leukemia. NURSING PRACTICE IMPLICATIONS: Nurses are essential in the management of patients with acute leukemia both in and out of the hospital. As a result, having a basic understanding of these illnesses is critical. In the management of oncologic crises, early symptom identification is crucial.

Group psychodrama for children with leukemia: A brief report.

OBJECTIVE: Group psychodrama for children is one of the methods of group therapy in treatment of many behavioral and emotional disorders of children. However, it has been used very few in hospital settings. So, in this study, the group psychodrama was applied to evaluate its effectiveness for. METHOD: Sixteen children with leukemia aged 6-9 years participated in the present randomized controlled trial. Eight children in the intervention group and eight children in the control group were randomly assigned. The intervention group participated in eight sessions of group psychodrama (during the hospitalization time) and the control group waited for the treatment. The score of the bio-psycho-social expressions of incompatibility in hospital (BPSEIH) checklist was the criterion of evaluation of the group psychodrama effectiveness. RESULTS: The results showed that group psychodrama was significantly effective in modifying the BPSEIH. CONCLUSIONS: The findings indicate the effectiveness of group psychodrama to moderate the psychological consequences of cancer and showed the feasibility of using this method in the hospital settings.

Kynurenine pathway activation and deviation to anthranilic and kynurenic acid in fibrosing chronic graft-versus-host disease.

Fibrosing chronic graft-versus-host disease (cGVHD) is a debilitating complication of allogeneic stem cell transplantation (alloSCT). A driver of fibrosis is the kynurenine (Kyn) pathway, and Kyn metabolism patterns and cytokines may influence cGVHD severity and manifestation (fibrosing versus gastrointestinal [GI] cGVHD). Using a liquid chromatography-tandem mass spectrometry approach on sera obtained from 425 patients with allografts, we identified high CXCL9, high indoleamine-2,3-dioxygenase (IDO) activity, and an activated Kyn pathway as common characteristics in all cGVHD subtypes. Specific Kyn metabolism patterns could be identified for non-severe cGVHD, severe GI cGVHD, and fibrosing cGVHD, respectively. Specifically, fibrosing cGVHD was associated with a distinct pathway shift toward anthranilic and kynurenic acid, correlating with reduced activity of the vitamin-B2-dependent kynurenine monooxygenase, low vitamin B6, and increased interleukin-18. The Kyn metabolite signature is a candidate biomarker for severe fibrosing cGVHD and provides a rationale for translational trials on prophylactic vitamin B2/B6 supplementation for cGVHD prevention.

Slow-Stroke Back Massage Compared With Music Therapy for Leukemia-Related Pain and Fatigue: A Randomized Controlled Trial.

PURPOSE: Comparison of two safe complementary medicine methods to treat cancer-related pain and fatigue in adult patients with acute leukemia during active treatment with chemotherapy. METHODS: A randomized trial with three groups (light massage, music therapy, and standard care) in Ahvaz, Iran, between 2018 and 2019. A total of 104 participants of the massage and music therapy groups received 15-minute intervention sessions, thrice weekly for 4 weeks, and participants of the control group received standard care. Cancer-related pain and fatigue intensity were measured by numeric self-report rating scales. During the 4 weeks of the interventions, pain and fatigue intensity were measured weekly. All the groups were followed up for 2 weeks after the end of the intervention. RESULTS: Pain and fatigue intensity decreased significantly over time between the intervention groups compared with the standard care group. In the massage and music therapy groups, a progressive reduction of pain and fatigue intensity over time (from the baseline to the fourth week) was observed. Fatigue intensity did not differ between the two intervention groups. Pain intensity decreased more in the massage group compared with the music therapy group. The durable effects of the massage therapy were greater compared with the music therapy 2 weeks after the intervention was completed. CONCLUSION: Light massage was more effective and persisted longer than the music therapy for controlling leukemia-related pain and fatigue in adult patients with acute leukemia.

Gut microbiota composition influences outcomes of skeletal muscle nutritional intervention via blended protein supplementation in posttransplant patients with hematological malignancies.

BACKGROUND: Skeletal muscle atrophy is an important and independent predictor of survival after hematopoietic stem cell transplantation (HSCT). Our previous study found that soy-whey blended protein (SWP) can improve muscle mass in acute leukemia patients. OBJECTIVE: We aimed to explore potential factors that influence muscle outcomes after nutritional intervention. METHODS: In this case-control study, 13 patients who received HSCT and failed to improve muscle function within half a year were included. After two months of SWP intervention, the subjects were divided into two groups (MSI: muscle status improved; MNI: muscle status not improved). 16S rDNA sequencing, principal coordinate analysis (PCoA) and the PICRUSt algorithm were used to analyze the composition, structure and function of the intestinal microbiota between the groups. This study was registered in the Chinese Clinical Trial Registry (ChiCTR 1800017765). RESULTS: SWP significantly improved muscle status (muscle area: from 330.4 mm2 to 384.8 mm2, p = 0.02; muscle strength: from 19.2 kg to 21.3 kg, p = 0.04). However, there were a small number of subjects whose muscle status was not effectively improved. After SWP intervention, the diversity (Shannon: from 1.7 to 3.8, p = 0.01; Simpson: from 0.6 to 0.8, p = 0.015) of the intestinal microbiota in the MSI group increased significantly, whereas that in the MNI group did not. Principal component analysis (PCA) revealed separate groupings of the microbiota of the Baseline-MSI and Endpoint-MSI time points in the MSI group. Opposite patterns of microbial abundance change were found between the MSI group (75% of changed genera were increased) and the MNI group (80% of changed genera were decreased). Three bacterial taxa (negative correlation: Streptococcus; positive correlations: Ruminococcus and Veillonella) were significantly related to muscle improvement outcomes. Both pentose phosphate (p = 0.048) and amino acid biosynthesis (p = 0.039), which are related to muscle metabolism, were found to be significantly changed in the MSI group through PICRUSt algorithm prediction. CONCLUSIONS: Our results suggest that the intestinal microbiota plays important roles in the regulation of muscle metabolism.

The Effect of Auricular Acupressure on Sleep Disturbance Among Patients With Leukemia: A Feasibility Study.

Auricular acupressure (AA) is widely used in East Asia and Europe to manage patients with sleep disturbance. This feasibility study was performed to demonstrate the potential of AA for sleep disturbance in patients with leukemia. Thirty-two patients with leukemia with poor sleep quality received AA 3 times a day for a total of 4 weeks. The Pittsburgh Sleep Quality Index (PSQI) was used to assess sleep quality at baseline, at a 2-week intervention, and after a 4-week intervention. Compared with baseline scores, PSQI scores and the use of sleep medicine were significantly improved at week 2 and week 4 (P < .05). As a potential safety therapy, AA could be an alternative or complementary intervention to improve sleep quality for patients with leukemia with sleep disturbance.

Bloodstream infection by multidrug-resistant Streptococcus oralis in a leukemic patient with febrile neutropenia after hematopoietic stem cell transplantation.

We reported the case of a patient with leukemia who developed febrile neutropenia after hematopoietic stem cell transplantation. Blood culture results revealed the presence of Streptococcus oralis, while antimicrobial susceptibility testing showed the resistance to penicillin and cephem. Furthermore, isolates were not susceptible to either meropenem or daptomycin but not to vancomycin. S oralis is known to belong to Streptococcus mitis group and be a causative agent of bacteremia in the neutropenic patients, but multidrug resistance of S oralis is rare. Our findings suggest that we might pay attention to the emergence of the microorganisms acquiring multidrug resistance in neutropenic patients.

Precision Nutrition and Cancer Relapse Prevention: A Systematic Literature Review.

Cancer mortality rates are undergoing a global downward trend; however, metastasis and relapse after surgery and adjuvant treatments still correlate with poor prognosis and represent the most significant challenges in the treatment of this disease. Advances in genomics, metabolomics, and proteomics are improving our understanding regarding cancer metabolic diversity, resulting in detailed classifications of tumors and raising the effectiveness of precision medicine. Likewise, the growing knowledge of interactions between nutrients and the expression of certain genes could lead to cancer therapies based on precision nutrition strategies. This review aims to identify the recent advances in the knowledge of the mechanistic role of bioactive phytochemicals in foodstuffs in tumor progression, metastasis, and chemo-resistance in order to assess their potential use in precision nutrition therapies targeting relapse in lung, breast, colon, and prostate cancer, and leukemia. A considerable number of bioactive phytochemicals in foodstuffs were identified in the literature with proven effects modulating tumor growth, progression, and metastasis. In addition, the use of foodstuffs in cancer, and specifically in relapse therapies, is being reinforced by the development of different formulations that significantly increase the therapeutic efficiency of these products. This can open the possibility for testing combinations of bioactive phytochemicals with cancer relapse treatments as a potential prevention strategy.

Research agenda for life-threatening cancer.

OBJECTIVES: The aim of this study was to identify future research agendas that reflect the concerns and unexplored areas of interest for patients with life-threatening cancer, their relatives and the clinical specialists during the cancer trajectory. METHODS: Six focus group discussions were conducted addressing two different cancer trajectories: primary malignant brain tumour and acute leukaemia. For each of the two cancer trajectories, separate FGIs were carried out with patients, relatives and clinical specialists to identify important concerns, challenges and uncertainties. The FGIs were video/audio-recorded, transcribed and thematically analysed within and across FGI groups to construct research topics. Finally, the literature was reviewed for existing evidence concerning the identified research topic(s) to strengthen the suggested research agendas. RESULTS: New research agendas related to high-grade glioma brain tumour and acute leukaemia with corresponding research questions were formulated within the topics of supportive care/palliation, education/information, rehabilitation, complementary and alternative therapy and organization of health care. CONCLUSION: User involvement in identifying research agendas has the potential to improve quality of care for patients and caregivers across the cancer trajectory, while minimizing the gap in research between the healthcare user and healthcare provider.

Nutrition Care of Critically Ill Patients with Leukemia: A Retrospective Study.

Adults with acute leukemia (AL) are at high risk of malnutrition due to their disease and treatment side effects and may be admitted to the intensive care unit (ICU), further increasing the risk of malnutrition. Although ICU care includes some form of nutrition, patients typically receive less than prescribed energy and protein. Our objective was to characterize the nutrition care for critically ill patients with AL. We completed a retrospective review of adults with AL admitted to the Medical/Surgical ICU >24 hours. Descriptive statistics were performed on collected data including: demographics, APACHE II and Nutric scores, nutrition therapy, reasons for withholding nutrition, and mortality status at discharge. Data were collected on 154 AL patients with an average APACHE II score of 27 and Nutric score of 5.96. ICU mortality was 36%. Enteral nutrition (EN) was most commonly prescribed. Patients on EN received 55% of energy and 51% of protein prescribed. EN was commonly withheld for airway management and gastrointestinal impairment. Patients with AL received low amounts of energy and protein in the ICU and had a high Nutric score. Strategies and barriers to improve protein intake in this population are identified.

Iron Overload in Children with Leukemia Receiving Multiple Blood Transfusions.

OBJECTIVE: To find out prevalence of iron overload in children with leukemia at the end of treatment, and to identify factors affecting iron overload. METHODS: Children (age-1-14 y) treated for Leukemia of our center who completed treatment between January and August 2016 were included in the study. Serum ferritin and iron were measured at completion of treatment and total blood transfusion received throughout treatment was quantified. Serum ferritin >1000 ng/mL was considered as marker of transfusional iron overload. RESULTS: Out of 66 participants, 55 (83.3%) received red cell transfusions. Average transfused volume was 48 mL/kg, and patients with high-risk leukemia received more transfusions than standard-risk patients. 16 patients (24.2%) demonstrated transfusional iron overload. Total transfused volume and treatment intensity were significant factors associated with iron overload, and total transfused volume of >100 mL/kg (approximately 10 transfusions) was the most important determinant of transfusional iron burden. CONCLUSIONS: One-fourth of pediatric leukemia patients demonstrated iron overload at the end of treatment. These patients need to be monitored and followed-up after treatment to assess need for later chelation therapy.

[Significance of HLA 1-locus mismatch and ATG administration in unrelated hematopoietic stem cell transplantation].

HLA 1-locus-mismatched unrelated donors (1MMUD) are used in allogeneic hematopoietic stem cell transplantation (allo-HCT) for patients who lack an HLA-matched donor. Here we retrospectively reviewed 3,313 patients with acute leukemia or myelodysplastic syndrome who underwent bone marrow transplantation from an HLA allele-matched unrelated donor (MUD) or 1MMUD in 2009-2014. We compared the outcomes of MUD (n＝2,089) and 1MMUD with antithymocyte globulin [ATG; 1MM-ATG (＋) ; n＝109] with those of 1MMUD without ATG [1MM-ATG (-) ; n＝1,115]. In the 1MM-ATG (＋) group, the median total dose of ATG (thymoglobulin) was 2.5 (range, 1.0-11.0) mg/kg. The rates of grade III-IV acute GvHD, non-relapse mortality (NRM), and overall mortality were significantly lower in the MUD group than in the 1MM-ATG (-) group [hazard ratio (HR) 0.77; P＝0.016; HR, 0.74, P<0.001; and HR, 0.87, P＝0.020, respectively]. Similarly, the rates of grade III-IV acute GvHD, NRM, and overall mortality were significantly lower in the 1MM-ATG (＋) group than in the 1MM-ATG (-) group (HR, 0.42, P＝0.035; HR, 0.35, P<0.001; and HR, 0.71, P＝0.042, respectively). Even in the recent cohort, the outcome of allo-HCT from 1MM-ATG (-) was inferior to that of allo-HCT from MUD. Nevertheless, the negative impact of 1MMUD disappeared with the use of low-dose ATG without exacerbating the risk of relapse.

The growth of K562 human leukemia cells was inhibited by therapeutic neural stem cells in cellular and xenograft mouse models.

To confirm the anti-tumor effect of engineered neural stem cells (NSCs) expressing cytosine deaminase (CD) and interferon-ß (IFN-ß) with prodrug 5-fluorocytosine (FC), K562 chronic myeloid leukemia (CML) cells were co-cultured with the neural stem cell lines HB1.F3.CD and HB1.F3.CD.IFN-ß in 5-FC containing media. A significant decrease in the viability of K562 cells was observed by the treatment of the NSC lines, HB1.F3.CD and HB1.F3.CD.IFN-ß, compared with the control. A modified trans-well assay showed that engineered human NSCs significantly migrated toward K562 CML cells more than human normal lung cells. In addition, the important chemoattractant factors involved in the specific migration ability of stem cells were found to be expressed in K562 CML cells. In a xenograft mouse model, NSC treatments via subcutaneous and intravenous injections resulted in significant inhibitions of tumor mass growth and extended survival dates of the mice. Taken together, these results suggest that gene therapy using genetically engineered stem cells expressing CD and IFN-ß may be effective for treating CML in these mouse models.

A Controlled Trial of Sheng-Yu-Tang for Post-Hematopoietic Stem Cell Transplantation Leukemia Patients: A Proposed Protocol and Insights From a Preliminary Pilot Study.

INTRODUCTION: Hematopoietic stem cell transplantation has become a well-established treatment for hematologic disorders including acute leukemia. However, long-term survival rates following this procedure are still extremely low, due to posttransplantation relapse, infections, and graft-versus-host disease. We propose that adjunctive Chinese herbal medicine may benefit posttransplantation patients. In preparation for a randomized clinical trial, we conducted a pilot trial. Methods and Analysis: Between September 2015 and June 2017, 18 patients were consecutively enrolled at China Medical University Hospital and followed for up to 1 year. Fresh blood samples were obtained on a monthly basis, and immune reconstitution was analyzed. In addition to the standard-care treatment administered by their oncologist, a number of patients also received a Chinese herbal formula (Sheng-Yu-Tang) for up to 6 months. Results were used to improve on study protocol and estimate required sample size for a future randomized trial. Ethics and Dissemination: Study protocol was approved by the institutional review board of China Medical University Hospital (DMR-105-005), and all participants provided informed consent.