bluuebunny/crossref_metadata_2025_split huggingface dataset:
Randomized double-blind, placebo-controlled multicenter phase III study of prevention of irinotecan-induced diarrhea by a probiotic mixture containing Bifidobacterium, BB-12 and Lactobacillus rhamnosus, LGG in colorectal cancer patients: The Probio SK 006-Slovak cooperative oncology group trial.
Authors: Mego Michal , Danis Radoslav , Chovanec Jozef , Jurisova Silvia , Bystricky Branislav , Porsok Stefan , Konkolovsky Peter , Vaclav Vladimir , Wagnerova Maria , Stresko Marian , Brezinova Bibiana , Reckova Maria , Sutekova Dagmar , Pazderova Natalia , Novisedlakova Maria , Zomborska Eva , Ciernikova Sona , Svetlovska Daniela , Drgona Lubos 
Published: June 2023

e24109 Background: The incidence of irinotecan-induced diarrhea varies between 60-90%, by which the incidence of severe diarrhea is 20-40%. The objective of this phase III trial was to determine the effectiveness of the probiotic mixture containing Bifidobacterium, BB-12 and Lactobacillus rhamnosus, LGG in the prophylaxis of irinotecan-induced diarrhea in metastatic colorectal cancer patients due to a reduction in the activity of intestinal beta-D-glucuronidase. Methods: From March 2016 to May 2022, a total of 242 patients with colorectal cancer starting a new line of irinotecan-based therapy were registered to the study in 11 cancer centers in Slovakia. Patients were randomized in a ratio 1:1 to probiotic formula vs. placebo that was administered for 6 weeks. Each capsule of Probio-Tec BG-Vcap-6.5 contained 2.7x109colony-forming units (CFU) of 2 lyophilized probiotic strains Bifidobacterium, BB-12 (50%) and Lactobacillus rhamnosus GG, LGG (50%). Results: Administration of probiotics compared to placebo was not associated with a significant reduction of grade 3/4 diarrhea (placebo arm 11.8% vs. probiotic arm 7.9%, p = 0.38). Neither the overall incidence of diarrhea (46.2% vs. 41.2%, p = 0.51) nor the incidence of enterocolitis (3.4% vs. 0.9%, p = 0.37) was different in the placebo vs. probiotic arm. Subgroup analysis revealed that patients with colostomy had higher incidence of any diarrhea and grade 3/4 diarrhea in the placebo arm compared to the probiotic arm (48.5% vs. 22.2%, p = 0.06 and 15.2% vs. 0%, p = 0.06, respectively). Moreover,patients on probiotic arm had significantly better diarrhea-free survival (HR = 0.41, 95%CI 0.18 – 0.95, p = 0.05) and needed less loperamide (p = 0.01) compared to patients on placebo arm. We did not observe any infection caused by probiotic strains used in this study. Conclusions: This study failed to achieve its primary endpoint, and results suggest a lack of benefit of administered probiotic formula for the prevention of irinotecan-induced diarrhea. However, subgroup analysis suggests a possible benefit in patients with colostomy. Clinical trial information: NCT02819960 .
Clinical research policy for oral mucositis associated with cancer treatment (J-SUPPORT).
Authors: Yokota Tomoya , Ueno Takao , Soga Yoshihiko , Ishiki Hiroto , Uezono Yasuhito , Mori Takehiko , Zenda Sadamoto 
Published: June 2023

e24110 Background: Oral mucositis is one of the main areas of research in supportive and palliative care of cancer patients. However, the methodology of prospective clinical trials on oral mucositis has not been established, despite its uniqueness. Here, we propose a novel research policy on oral mucositis, including an implementable set of recommendations for researchers conducting clinical trials. Methods: The first draft was developed by an expert panel of six specialists from the Japanese Supportive, Palliative, and Psychosocial Care Study Group. A provisional draft was developed after review by the following medical societies: the Japanese Association of Supportive Care in Cancer, the Japanese Association of Oral Supportive Care in Cancer, the Japanese Cancer Association, and the receipt of public comments. Results: The research policy on oral mucositis mainly consists of the following components: (i) definition of oral mucositis; (ii) characteristics of oral mucositis; (iii) characteristics of oral mucositis research; (iv) target population for oral mucositis research; (v) endpoints and assessment measures in oral mucositis; (vi) eligibility criteria; (vii) research design; and (viii) minimally recommended intervention in oral mucositis research as a supplement. The final policy (Ver1.0) was completed on August 16, 2021. Conclusions: This policy may serve as a significant reference for planning and conducting clinical trials for the management of oral mucositis.
Morbidity of single-fraction spine radiosurgery for metastatic disease.
Authors: Gardner Ulysses Grant , McClelland Shearwood 
Published: June 2023

e24116 Background: The optimal management of metastatic spine disease involves radiation therapy, with stereotactic radiosurgery (SRS) utilization having increased in adoption while proving to be efficacious and safe. Spine SRS morbidity (fatigue, dermatitis, nausea and esophagitis) is generally mild and depends on the spinal vertebral level(s) treated. More severe adverse events such as vertebral compression fracture (VCF), radiation-induced myelopathy, and tracheoesophageal (TE) fistula have been documented. The potential benefits of single-fraction SRS (sfSRS) over multi-fraction SRS include increased patient convenience, decreased financial toxicity, and increased treatment completion rates. These benefits may potentially be overshadowed by the morbidity of sfSRS versus multifraction SRS. In this analysis, we perform the first comprehensive examination of sfSRS morbidity in the treatment of spinal lesions. Methods: An extensive search of the PubMed database was undertaken through 2/2/23 to find studies examining spinal sfSRS. Search parameters included the terms “single-fraction, spine, radiation SRS OR SBRT” Articles including multi-fractionated regimens only, reviewed sites outside of the spine, or did not report on clinical outcomes/toxicities were excluded. Results: 17 articles met initial inclusion criteria; 9 were added from references for a total of 26 articles comprising at least 2,699 patients (one study reported the number of tumors, not patients). Dose ranges for single-fraction SRS were 8-26 Gy. Commonly noted toxicities were fatigue, nausea/vomiting, and dermatitis which were no worse than moderate/minimal, not requiring invasive intervention. The overall rate of VCF was 16.2%, with an increased propensity at >20 Gy. The proportion of reported segments requiring surgical intervention (operative stabilization, vertebroplasty/kyphoplasty) for VCF after single-fraction SRS was 20.2% (33/163). The rate of TE fistula at 25 Gy was 8.3%, with an overall rate (dose range = 10-28 Gy) of 1.3% with up to 12-years of follow-up. In patients receiving median dose of 24 Gy, the rate of severe esophagitis was 6.8%, myositis was 1.3% (at 1-year) and 8.3% (at 5-years). The rate of peripheral nervous system injury was 2.5% (at 18-26 Gy) and pain flare was 8% (at 16-24 Gy). The rate of ureteral and esophageal stricture was 1.9% each in patients receiving 12-24 Gy. Conclusions: VCF is the most commonly reported severe adverse events with single-fraction spine SRS, particularly for doses > 20 Gy. 80% of VCFs can be successfully managed without invasive intervention. Other severe adverse events are rare – particularly for < 20 Gy – but require post-SRS monitoring to expediently and efficiently intervene if necessary. These findings indicate that single-fraction spine SRS to < 20 Gy is safe with minimal morbidity. Further study regarding the efficacy of such dosing is being evaluated in ongoing clinical trials.
A pilot study to determine the effects of early palliative care integration on patients with newly diagnosed multiple myeloma.
Authors: Samala Renato Verayo , Valent Jason Neil , Wei Wei , Crook Jasmine , Fada Sherry 
Published: June 2023

e24118 Background: While multiple studies underscore the value of early palliative care (PC) involvement in patients suffering from cancer, particularly solid tumors, the effect of early integration on the care of patients with multiple myeloma is not as widely known. This study aims to obtain preliminary data on the effects of early PC involvement on patients with newly diagnosed symptomatic multiple myeloma. Methods: This is a pilot study with a prospective cohort design and based in the outpatient setting. Patients at least 18 years of age and within eight weeks of diagnosis were included. Each participant was seen by a PC specialist monthly for 12 months for ongoing symptom management and advance care planning. Quality of life was assessed using Functional Assessment of Cancer Therapy-General (FACT-G), plus the Multiple Myeloma Subscale (FACT-MM). Hospital Anxiety and Depression Scale (HADS) was used to estimate the number of participants with self-reported symptoms of depression and anxiety. Questionnaires were administered upon enrollment and every three months for 12 months. The percentage of participants who completed the study was assessed to determine the feasibility of this approach. Results: Of the twenty participants enrolled from January 2020 to November 2022, median age was 65 (range 40, 77), 15 (75%) were female, 15 (75%) were white and 11 (55%) had an Eastern Cooperative Oncology Group Performance Status score of 1. Eighty-five percent of participants completed assessment at three months, 65% at 6 months, 65% at 9 months, and 60% at 12 months. FACT-G total score was significantly higher (increased by 15.1 points) at 12 months compared to baseline (adjusted 95% CI: 2.2-28.1, adjusted p = 0.018). Functional well-being (FWB) subscale score was significantly higher (increased by 5.0 points) at 9 months compared to baseline (adjusted 95% CI: 0.5-9.5, adjusted p = 0.025), and at 12 months compared to baseline (adjusted 95% CI: 1.1-10.9, adjusted p = 0.012). Depression and anxiety scores did not significantly change over time. Conclusions: Improvement in quality of life was seen among patients with newly diagnosed symptomatic multiple myeloma after 12 months of early PC involvement. Monthly PC visits appeared to be feasible for these patients. Clinical trial information: NCT04248244 .[Table: see text]
Availability of palliative specialty care for adults in community oncology: Results from the 2022 NCORP landscape assessment.
Authors: Statler Tiffany M. , Dressler Emily Van Meter , Kittel Carol A , Foust Melyssa , Loh Kah Poh , Weaver Kathryn E. , Klepin Heidi D. , Nightingale Chandylen L , Gabbard Jennifer 
Published: June 2023

e24125 Background: Palliative care promotes timely symptom management, and care planning and improves quality of life in oncology patients. About 60% of community oncology practices sampled in 2015 had outpatient palliative care. This study updates estimates of palliative care resources in community oncology. Methods: Questions from the 2022 Landscape Assessment of National Cancer Institute Community Oncology Research Program (NCORP) (funding provided by 2UG1CA189824) assessed the availability of specialist palliative care providers and ancillary care services, including utilization of advanced practice providers (APPs). Descriptive statistics describe availability of providers and services. Multivariable logistic regression was used to identify practice characteristics associated with palliative care specialist availability in 2022. Differences in rates of palliative care specialists, outpatient palliative care, APPs and patient portal use between 2015 and 2022 assessment results were assessed using Chi-Square tests, assuming independent time snapshots of general population characteristics. Results: Most community oncology practices sampled in 2015 had palliative care specialists (76%) and 62% of practices reported having outpatient palliative care. Of the 259 non-pediatric exclusive NCORP practice groups included in the 2022 analyses (Table 1), significantly more had palliative care specialists (86%; p = 0.003) and offered palliative care in the outpatient setting (76%; p = 0.001). Most practices utilized APPs (92%) and had a patient portal (95%), while only 41% had a survivorship clinic. Multivariable analyses demonstrated practices with more adult oncology providers (OR = 1.03, p = 0.039) and those with a designated survivorship clinic (OR = 3.16, p = 0.001), were significantly more likely to have specialty palliative care in the outpatient setting. Conclusions: More practices reported availability of palliative care specialists and outpatient services in community oncology practices in 2022 compared to 2015, with more oncology providers being associated with increased odds of having outpatient specialty palliative care in 2022. Smaller community oncology practices with fewer providers may need support to expand their capacity to provide palliative care. [Table: see text]
Sexuality as a prognostic factor: Results of an individual participant data NOGGO-meta-analysis of 1,041 recurrent ovarian cancer patients before starting chemotherapy.
Authors: Balint Nicole , Pirmorady-Sehouli Adak , Richter Rolf , Zocholl Dario , Woopen Hannah , Pietzner Klaus , Sehouli Jalid 
Published: June 2023

e24128 Background: Until now there is very little data available about sexuality in ovarian cancer patients. Aim was analyze if sexuality is associated with clinical parameters, quality of life, prior discontinuation of chemotherapy and survival in recurrent ovarian cancer patients before starting chemotherapy. Methods: Raw data including the QLQ-C30 and QLQ-OV28 EORTC questionnaire from four phase II/III trials (“Tower”, “Treosulfan”, “Hector” and “TRIAS”) conducted by the North-Eastern German Society of Gynecological Oncology (NOGGO) were synthesized for this individual participant data meta-analysis using ANOVA and cox regression analyses. All study participants were diagnosed with recurrent ovarian cancer and data for this analysis was gained before starting chemotherapy. Three patient groups were defined: (1) patients without interest in sex and not being sexually active, (2) patients with interest in sex and not being sexually active and (3) patients with interest in sex and being sexually active. Results: Data on sexuality was available from 644 patients with 437 patients without interest in sex and not being sexually active (1), 45 patients with interest in sex and not being sexually active (2) and 162 patients with interest in sex and being sexually active (3). Women of the third group were significantly younger with a median age of 57 years at randomization compared to women of group (1) with a median age of 65 years, p < 0.001. Women with interest in sex and who were sexually active showed also a significant better ECOG performance status (p < 0.001), had a lower number of recurrences (p < 0.001) and had less frequently ascites at diagnosis (p < 0.002). There were no differences regarding FIGO stage, BMI and grading between the three groups. Sexuality was associated with global quality of life (p < 0.001) and physical, psychological, social, emotional and role functionality (p < 0.001). Patients who were sexually active, reported less fatigue (p < 0.001), less pain (p < 0.001), less sleeping disorders (p = 0.004), less diarrhea (p = 0.008), less nausea and vomiting (p = 0.007) and less loss of appetite (p < 0.001). There was no association with prior discontinuation of chemotherapy. Median overall survival (OAS) was 16.7 months in platinum-resistant patients being sexually active compared to a median OAS of 8.7 months in platinum-resistant patients who are not sexually active (p = 0.016). Conclusions: Medical personnel should routinely address sexuality in ovarian cancer patients as sexuality seems to be a marker for both QoL and overall survival and warrants further investigation.
“It’s been a long journey:” A qualitative study of patient and caregiver experiences during multimodality treatment for locally advanced rectal cancer.
Authors: Lau-Min Kelsey S. , Psenka Riley , Massad Katina , El-Jawahri Areej , Temel Jennifer S. , Parikh Aparna Raj , Nipp Ryan David , Traeger Lara 
Published: June 2023

e24130 Background: Locally advanced rectal cancer (LARC) is treated with multimodality therapy including chemotherapy, radiation, and surgery to maximize the potential for cure. However, this aggressive treatment approach can result in substantial toxicity for patients, including life-altering changes in bowel, urinary, and sexual function as well as decrements in quality of life. We aimed to explore the lived experiences of patients and caregivers during multimodality treatment for LARC. Methods: We conducted a qualitative study of patients ≥18 years old undergoing multimodality treatment for LARC at the Massachusetts General Hospital, as well as their designated caregivers. We used purposive sampling to maximize variation in participant age, gender, and treatment status pre- versus post-surgery. Each participant completed a one-hour individual in-depth interview using a semi-structured interview guide covering treatment experiences, coping strategies, and supportive care needs. We audio recorded, transcribed, and coded interviews using an iterative approach, after which we analyzed the data using thematic analysis and constant comparison methods. Results: We included 21 patients (median age 51 years, 11 female, 18 white, 10 post-surgical resection) and 9 caregivers (median age 49 years, 8 white, 6 married/living with patient). Patients and caregivers reported that the lengthy and complex nature of treatment for LARC made it difficult for them to fully understand and navigate their treatment trajectories. The multimodality treatment approach presented several challenges with care coordination; discordant recommendations between treatment team members; and an overarching sense of unpredictability with respect to treatment timelines, complications, and impact on patients’ personal, work, and family lives. Patients and caregivers reported wishing that they had received more detailed information about each treatment phase upfront but recognized that the initial shock of a LARC diagnosis may have impeded their ability to absorb this new information. Many resorted to their own internet searches to address their unanswered questions but often found themselves returning to their treatment teams to clarify misperceptions and manage the additional distress they experienced online. Conclusions: Patients and caregivers face critical challenges in navigating treatment for LARC due to the lengthy, complex, and unpredictable nature of this treatment approach. Many resorted to their own internet searches and reported feeling misinformed, distressed, or regretful about the information found online. Findings from this study will inform the development of interventions to enhance information delivery and processing for patients undergoing multimodality treatment for LARC.
Wireless transcutaneous electric nerve stimulation (TENS) for chemotherapy-induced peripheral neuropathy (CIPN): A proof-of-concept, placebo-controlled, randomized clinical trial (RCT).
Authors: Gewandter Jennifer S. , Culakova Eva , Davis Jenae N , Gada Umang , Guido Joseph John , Burnette Brian Leslie , Bearden James D. , O'Rourke Mark Allen , Mustian Karen Michelle , Morrow Gary R. , Sluka Kathleen A , Mohile Nimish 
Published: June 2023

e24134 Background: Chronic CIPN affects approximately 30%-60% of people who receive neurotoxic chemotherapy. CIPN is associated with impaired quality of life and function and has few effective treatments. Methods: This 6-site, subject and assessor blinded RCT was designed to assess (1) preliminary efficacy (i.e., alpha pre-specified at 0.2) of a wearable, app-controlled, TENS device for chronic CIPN and (2) feasibility of conducting a confirmatory trial within the NCI Community Oncology Research Program (NCORP) (NCT 04367480). The primary outcome was the EORTC-CIPN20. The main secondary outcomes were hot/burning pain, sharp/shooting pain, tingling, numbness, and cramping (7-day daily diary, 0 – 10 numeric rating scales). The TENS device applies stimulation for 1hr treatment sessions followed by 1 hour rest periods. The placebo TENS device is identical, except it delivers only 2.5 mins of stimulation in the treatment period. Subjects were asked to wear the device for 5 hrs/day (i.e., 3 treatment sessions) for 6 weeks. The primary analysis used an ANCOVA with the 6-week EORTC-CIPN20 score as the dependent variable, arm as fixed effect, and baseline EORTC-CIPN20 and site as covariates. Secondary analyses used similar ANCOVA models (excluding site) for each symptom on subgroups of subjects who reported at least 4 out 10 for that symptom at baseline. Results: 142 eligible subjects were randomized and received a device; 130 (91%) completed the study. Subjects were on average 63 years old, 65% female, and 85% white. The most common chemotherapies were taxanes (37%), platinums (36%), or their combination (15%). 88% of study completers received at least 3 treatment sessions on at least 70% of study days. The median time since chemotherapy was 16 months (IQR: 7, 34). See Table for efficacy results. Conclusions: A RCT of an app-controlled, wireless TENS device for chronic CIPN with excellent adherence and retention rates is feasible in NCORP. Preliminary efficacy evidence suggests that TENS is promising for pain and cramping from CIPN, but less likely to improve numbness and tingling. A confirmatory RCT of TENS for painful CIPN is highly warranted. Clinical trial information: NCT04367480 . [Table: see text]
Use of Myeloma Patient Outcome Scale (MyPOS) to gauge the effectiveness of palliative management in patients with multiple myeloma: Experience from a large tertiary academic center in India.
Authors: Koolwal Kapoor Astha , Mishra Seema , Bhatnagar Sushma , Kumar Lalit , Garg Rakesh , Gupta Nishkarsh , Kumar Vinod , JeeBharti Sachidanand 
Published: June 2023

e24137 Background: A diagnosis of Multiple Myeloma (MM) can carry significant physical, social, functional and emotional repercussions. There is a lack of data on Baseline Quality of Life (QOL) in patients with MM and effectiveness of palliative management in the Indian context, especially after the advent of newer chemo-immunotherapeutic agents and autologous stem cell transplant (ASCT). Myeloma Patient Outcome Scale (MyPOS) is the first questionnaire developed specific for MM patients. Objectives and Methods: To evaluate symptom burden and quality of life in MM patients admitted to the medical oncology ward. To assess change in quality of life and symptoms as well as analgesic requirements on telephonic follow up after one and three months from index admission. After institutional ethical clearance, MM inpatients were prospectively enrolled. Clinical and treatment related details were recorded. MyPOS questionnaire was administered as well as a detailed pain assessment using Brief Pain Inventory (BPI) was carried out at baseline, 1 and 3 months. Results: 82 out of 100 MM patients consented for recruitment (Mean age- 52 +/- 9yrs; Male- 55%). Mean duration of the disease since diagnosis was less than 1 year (0.86 years), with a mean International staging system (ISS) score of 2. Up to half (37/82, 45%) of the patients received ASCT in addition to chemotherapy. The baseline Global MyPOS Score was 58 +/- 8.8 while the mean Pain severity (MPS) and interference (MPI) scores were 25+/-8 and 43+/-10 respectively. The most painful region was the back. Only Tramadol was sufficient for a small minority (6/82, 7.4%), most required oral morphine. Most patents had significant interval improvement in their pain and QOL scores with a p less than 0.01 on follow-up (MyPOS at 1 month and 3 month were 81+/-6 and 78+/-5, MPS were 21+/-13 and 17+/-1.1, MPI were 38+/-2.2 and 37+/-2.1 respectively). Conclusions: Adequate pain management can significantly improve quality of life in MM patients. Use of standardized questionnaires such as MyPOS is a quintessential tool for the palliative specialist in order to gauge therapeutic efficacy.