bluuebunny/crossref_metadata_2025_split huggingface dataset:
Vitamin D3 supplementation to improve fatigue in patients with advanced cancer.
Authors: Trivanovic Dragan , Plestina Stjepko , Dobrilla-Dintinjana Renata , Honovic Lorena , Jerin Lems , Hrstic Irena 
Published: March 2020

9097 Background: Fatigue is one of the most common symptoms of patients diagnosed with cancer. Vitamin D deficiency has been associated with an increased risk of mortality in oncology patients. We conducted a prospective vitamin D (cholecalciferol) supplementation study to analyse the response to oral D3 supplementation on fatigue in this population of chemo-naïve patients. Methods: Eligibility critera included life expectancy ≥ 6 months, ECOG PS 0-3, low serum 25-hydroxyvitamin D3 at the time of diagnosis (using cutoff value of 32 ng/mL), and normal serum calcium level. Cancer related fatigue was measured with the Functional Assessment of Cancer Therapy Fatigue module (FACT-F). Patients were randomized to receive oral supplementation with 2,000 IU of Vitamin D3 daily for 3 months with standard cancer treatment or to continue standard treatment without vit D3 supplementation. Primary endpoint was changes in the FACT-F scale. Secondary endpoints was improvement of vitamin D serum levels and safety. Results: 69 vit D deficient patients enrolled in the this study between November 2009 and November 2011 returned a baseline FACT-F. The mean serum 25(OH)D levels were 18.7 ng/ml (SD = 7.4) at baseline. Patients in experimental arm showed marked improvement from baseline in fatigue (p<0.05) and vitamin D serum levels after 3 months (p<0.001). There were significant difference in fatigue score in patients with experimental arm and control arm after 3 months of treatment (p< 0.001). Conclusions: Vitamin D supplementation resulted in a significant increase in Fatigue score and serum 25(OH)D levels in vitamin D deficient patients. Fatigue improve rapidly but remain worse in control arm. The safety profile of vitamin D in combination with chemotherapy or BSC was acceptable. [Table: see text]
Defining mild, moderate, and severe fatigue in cancer patients and survivors: E2Z02, a trial of the Eastern Cooperative Oncology Group.
Authors: Wang Xin Shelley , Zhao Fengmin , Fisch Michael , Mendoza Tito R. , O'Mara Ann M. , Cella David , Cleeland Charles S. 
Published: March 2020

9099 Background: Although mild, moderate and severe categories have been used in clinical guidelines for fatigue management in cancer patients, the optimal cutpoints on a 0-10 scale for delineating these categories have not been replicated. Methods: A multicenter ECOG study (E2Z02) enrolled breast, lung, prostate, or colorectal cancer patients with any treatment status. Fatigue and symptom interference were measured on the 0-10 numerical rating scale of the M. D. Anderson Symptom Inventory (MDASI). The optimal boundaries for categorizing fatigue severity were determined by the largest F ratios from MANOVA (Serlin’s criteria, 1995). Logistic regression with robust standard errors was used to identify risk factors for moderate/severe fatigue for cancer survivors (defined as patients with no evidence of disease and receiving no cancer treatment). Results: The optimal cutpoints that identified 3 distinct levels of fatigue severity for the 2341 patients were: ratings of 1-3 as mild, 4-6 as moderate, and 7-10 as severe. Known-group validity for these cutpoints was established by significant differences of fatigue severity by ECOG performance status and patient-reported quality of life (all P<0.001). Using these cutpoints, 45% (983/2177) of patients undergoing active therapy had moderate/severe fatigue, with significant more mild fatigue in breast and colorectal cancer patients, while more severe fatigue in lung cancer patients (p<.001). Among cancer survivors, 29% (150/515) had moderate/severe fatigue (breast 31%, colorectal 27%, prostate 22%, lung 33%). Younger age (OR=0.97, 95% CI=0.95-0.99) and poor performance status (OR=4.21, 95% CI=2.36-7.51) were associated with more moderate/severe fatigue in cancer survivors. Survivor time was also associated with moderate/severe fatigue in breast and colorectal cancer survivors (>=5yrs vs. <5yrs: OR=0.23, P<0.01 for breast, OR=9.3, P=0.03 for colorectal). Conclusions: This multicenter study confirmed the standard cutpoints for fatigue severity used in NCCN fatigue management guidelines. It also provides a profile of moderate to severe fatigue prevalence for actively treated cancer patients and for cancer survivors.
Changes in patient-reported outcomes in women with breast cancer in a multicenter double-blind randomized controlled trial assessing the effect of acupuncture in reducing aromatase inhibitor-induced musculoskeletal symptoms (AIMSS).
Authors: Bao Ting , Betts Kelly , Tarpinian Karineh , Cai Ling , Gould Jeff , Jeter Stacie , Medeiros Michelle , Tait Nancy , Chumsri Saranya , Armstrong Deborah Kay , Bardia Aditya , Tan Ming Tony , Stebbing Justin , Kelleher William Peter , Folkerd Elizabeth , Dowsett Mitchell , Singh Harvinder , Snyder Claire Frances , Tkaczuk Katherine Hanna , Stearns Vered 
Published: March 2020

9103 Background: Aromatase Inhibitors (AIs) have been associated with worsening of patient related outcomes (PROs) such as AIMSS, menopausal symptoms and depression. Acupuncture has been reported to alleviate such symptoms. We hypothesized that real acupuncture (RA) would improve PROs more than sham acupuncture (SA). Methods: We collected PROs at baseline, 4, 8, and 12 weeks (wks), from women enrolled in a multi-center double blind RCT designed to assess the effect of acupuncture in reducing PROs. Patients were randomized to 8 wkly RA or SA. PROs were measured by the revised National Surgical Adjuvant Breast and Bowel Project (NSABP) menopausal symptoms questionnaire, Center for Epidemiological Studies Depression Scale (CESD), Hospital Anxiety and Depression Scale (HADS), Pittsburgh Sleep Quality Index (PSQI), Hot Flash Daily Diary, Hot Flash Related Daily Interference Scale (HFRDI) and EuroQoL survey. We measured estrogen and cytokines concentrations at baseline and wk 8. We used Wilcoxon rank sum and signed-rank tests to make comparisons between and within group, respectively. Results: We included 23 patients from RA and 24 from SA arms in the intent-to-treat analysis. We have previously reported no significant difference in reduction of AIMSS between two arms. RA caused reduction of CESD scores compared to SA (median: -2 vs 0, p = 0.057). When compared to baseline, there were statistically significant improvements at wk 8 in hot flash severity score (p=0.006), hot flash frequency (p=0.011), HFRDI (p=0.014) and NSABP menopausal symptoms (p=0.022) scores in RA arm; for EuroQoL (p=0.022), HFRDI (p=0.043) and NSABP menopausal symptoms (p=0.005) scores in SA arm. The majority of patients’ estradiol concentrations were undetectable at baseline and wk 8. Changes in other time points, data and analysis of cytokines changes will be presented at the meeting. Conclusions: Real and sham acupuncture were both associated with improvement in PROs in breast cancer patients taking AIs. We detected no significant difference in the change of PROs between real and sham acupuncture, except for CESD.
Spiritual care provided by oncology physicians and nurses to advanced cancer patients.
Authors: Epstein-Peterson Zachary , Sullivan Adam , Phelps Andrea C. , Balboni Michael J. , Vanderweele Tyler J. , Balboni Tracy A. 
Published: March 2020

9116 Background: For many patients facing a diagnosis of advanced cancer, religion and/or spirituality (R/S) play an important role in coping with illness. Data suggest that cancer patients receiving spiritual care (SC) have better quality of life and receive less futile, aggressive interventions at the end of life. National palliative care guidelines include SC as a key component of end-of-life care. However, current SC practices and the role clinicians should play in SC provision remain unclear. Methods: The Religion and Spirituality in Cancer Care (RSCC) study is a survey-based, cross-sectional study of oncology physicians and nurses and advanced cancer patients from five Boston-area institutions. The survey elicited respondents’ R/S beliefs/practices, their views on the appropriateness of SC in the advanced cancer care setting, and their experiences in giving or receiving SC (e.g., spiritual history, referrals to chaplains). In total, 68 patients, 204 physicians, and 114 nurses responded (response rates: patients = 73%; clinicians = 63%). Multivariable analyses (MVAs) were performed to determine predictors (e.g., clinician demographics, R/S, spiritual care training) of SC provision by clinicians. Results: All respondents reported a low frequency of SC provision, with only 9% of patients receiving SC from physicians, 20% from nurses, and physicians reporting performing SC during only 8% of interactions, nurses during 12% of interactions. In MVAs, prior training in spiritual care was significantly associated with SC provision (OR physicians 5.89, CI 2.14-16.22; OR nurses 10.42, CI 1.30-89.19), as was the provider identifying as being spiritual (OR 3.85 physicians CI, 2.12-6.98; OR 2.92 nurses CI, 1.15-7.42). Conclusions: These data highlight the current inadequacies of SC provision by clinicians, despite national palliative care guidelines, and underscore the central role of SC training for doctors and nurses, as this was the strongest predictor of SC provision. Given the important role that SC has in end-of-life care and the paucity of data guiding its provision, we hope this research will advance the understanding of how to integrate SC into end-of-life care, and ultimately improve patient outcomes at the end-of-life.
Final results of a large collaborative, hospital-based quality improvement study aimed at the implementation of interventions for the psychosocial care of adult cancer patients (HUCARE project).
Authors: Passalacqua Rodolfo , Caminiti Caterina , Annunziata Mario , Borreani Claudia , Diodati Francesca , Fagnani Daniele , Isa Luciano , Filiberti Silvia , Ollari Maria Grazia , Saleri Jessica 
Published: March 2020

9120 Background: Incorporating psychosocial research into practice is challenging. Aim of this study is to assess the feasibility and effectiveness in real life of interventions which have been tested in RCTs and have demonstrated to improve pts psychosocial conditions Methods: This is an implementation study of five EBM interventions conducted in 28 centers. We adopted the model of Pronovost (BMJ 2008), which includes context analysis to identify local barriers; introduction of the interventions, and evaluation of how many pts receive the recommended interventions. Primary EPs: degree of implementation detected in a blinded fashion by external personnel. Interventions included: 1) EBM communication courses for doctors and nurses; 2) use of a question prompt list (QPL) for all pts; 3) creation of the Point of Information and Support (PIS) in the ward (J Clin Oncol 27:1794-99,2009); 4) identification of a referring nurse (RN) for informing and educating pts; 5) screening of distress and social needs. Results: In December 2008, 28 eligible centers applied to participate. 27 are evaluable and 1 is too early. 156 oncologists and 401 nurses attended the 3 days training course. A QPL was subjected to cross-cultural adaptation, yielding the first validated Italian QPL (BMC Health Serv Res 2010). 24 centers (89%) have successfully implemented the intervention; 3 centers failed for various reasons: internal conflicts of the staff, poor motivation, etc. Main results for each intervention are shown in the table. Conclusions: A successful implementation of EBM measure was obtained in the vast majority of oncology centers and yields to significant changes in the delivery of psychosocial care. Project funded by the Italian Ministry of Health and Lombardia Region. [Table: see text]
Prospective cohort study of chemotherapy-induced alopecia with or without scalp cooling.
Authors: Lemieux Julie , Maunsell Elizabeth , Provencher Louise , Lauzier Sophie , Younan Rami , Abdous Belkacem 
Published: March 2020

9138 Background: Scalp cooling can prevent chemotherapy-induced alopecia. Success varies according to the type of chemotherapy. A controversy exists regarding the use of scalp cooling because of the lack of efficacy data with modern chemotherapy regimen and safety data. We present a prospective cohort study design to measure alopecia. Methods: The prospective study was conducted at the Centre des Maladies du Sein Deschênes-Fabia (CMS) in Quebec City (where scalp cooling is offered routinely and 85% of women use it) and at the Centre Hospitalier Universitaire de Montreal (CHUM), in Montreal (where scalp cooling is not available). Women were eligible if they were going to receive neoadjuvant or adjuvant chemotherapy for breast cancer. The study involved completion of questionnaires (on degree of alopecia, hair type, hair care, use of head accessories, tolerance to scalp cooling and questions related to sick leave from work) and having pictures taken at baseline, cycle 3 and at the last cycle of chemotherapy. For the last 43 patients, the EORTC QLQ-C30/BR23 and an adaptation for Hairdex were added. Results: A total of 136 patients were recruited (110 at CMS over 2 years and 26 at the CHUM over a 9-month period). Preliminary efficacy results are shown in the Table (data on quality of life have not yet been analyzed). Hair preservation was defined as a SUCCESS for hair loss (since the beginning of chemotherapy) characterized as “not at all”, “a little” or “moderate” and “FAILURE” when characterized as “a lot” or “all” or “hair shaved”. Overall, in the scalp cooling group, 34% were considered a “success” using hairdresser evaluation and 49% using patient evaluation; for the non scalp-cooling group, these rates were 9% and 4% respectively. Conclusions: Scalp cooling appears to be efficacious for preventing chemotherapy-induced alopecia in this exploratory cohort study. [Table: see text]
Advance care planning (ACP) among hematopoietic cell transplant (HCT) patients and bereaved caregivers.
Authors: Loggers Elizabeth T , Lee Stephanie , Chilson Kate , Back Anthony , Block Susan , Loberiza Fausto R. 
Published: March 2020

9139 Background: HCT remains a high risk, potentially curative treatment typically offered to young, otherwise healthy patients with hematologic malignancies. Given this, patients and caregivers may not have considered end-of-life ACP. This study investigated the effect of pre-transplant ACP in surviving patients or bereaved caregivers. Methods: A retrospective, mixed-methods, audio-taped telephone survey adapted from validated instruments was conducted by a trained interviewer with English-speaking HCT survivors (n=18) and bereaved caregivers (n=11), 6-12 months post-HCT. Subjects were identified via HCT databases at two high-volume, tertiary centers between 2001-2003. Analysis included percentages from quantitative sections and qualitative transcripts coding by 2 investigators, with differences resolved by consensus. Results: HCT survivors [median age 47 years (range 33-67); 50% college-educated; all white] were interviewed a median of 13 months after HCT for acute leukemia (7), lymphoma (5), or other (6). Twelve (67%) had discussed mortality risk pre-HCT with the medical team; of these, 83% felt hope was increased or unchanged (I/U) and 100% felt clinician commitment to transplant was I/U by the conversation. Regardless of whether mortality was discussed, 50% had living wills and >75% had a formal proxy, yet 67% didn’t discuss mortality with family members pre-HCT. “Ignorance is bliss” was expressed by 6 survivors while 2 survivors regretted not discussing mortality risk. Bereaved caregivers [73% spouses; all W] were interviewed a median of 10 months after their loved one’s death, which occurred a median of 31 days (range 13-152) post-HCT. 100% were the patient’s proxy. Nine (82%) had discussed mortality risk pre-HCT with the medical team; of these, 78% felt hope was I/U, 100% felt clinician commitment to transplant was I/U, and 78% discussed EOL preferences with the patient pre-HCT, with 67% feeling ACP reduced burden. Four expressed appreciation for “the straight story.” Conclusions: Discussions of potential mortality with patients and caregivers before HCT did not affect hope, and supported confidence in medical teams.
Physical and functional well-being in women with breast cancer taking gabapentin for hot flashes.
Authors: Chandwani Kavita Dayal , Roscoe Joseph , Heckler Charles E , Mohile Supriya Gupta , Mustian Karen Michelle , Sprod Lisa , Janelsins Michelle Christine , Peppone Luke Joseph , Kirshner Jeffrey J. , Lord Raymond S. , Pandya Kishan J. , Guttuso Thomas , Morrow Gary R. 
Published: March 2020

9141 Background: Hot flashes reduce quality of life (QOL) in women with breast cancer. In a randomized, double-blind, placebo-controlled trial of gabapentin for hot flashes, 900 mg of the drug was found to reduce hot flashes in women with breast cancer; however, their QOL of has not been studied. We conducted secondary analyses to study two domains of QOL: physical (PWB) and functional well-being (FWB) in women in this trial. Methods: A nationwide sample of women with breast cancer and hot flashes ≥ 2/day was studied at baseline (T1), 4 weeks (T2), and 8 weeks (T3) of treatment with gabapentin 300mg/day (G300) and 900mg/day (G900) in divided doses, and a matching placebo (PL). PWB and FWB were assessed via subscales of the Functional Assessment of Cancer Therapy-Breast. Linear mixed model analyses of PWB and FWB were conducted, adjusted for demographic and treatment variables. Results: The mean age of women (N=384) was 54.9 years ± 8.07 (range: 31-81, 72% >50 years); 76% were married; 71% had more than high school education; 95% were Caucasian and 3% African-American; 10% were undergoing chemotherapy, and 9% radiotherapy (RT). PWB showed significant time effect (p<.0001) and interaction of time and treatment (p<.0001). There was an improvement in PWB in the G300 by T2 with no change at T3, while the improvement in PL and G900 was more modest at T2 and continued at T3 (PL - T1 20.7, T2 21.2, T3 21.6; G300 - T1 20.9, T2 22.2, T3 22.2; and G900 - T1 21.2, T2 21.5, T3 21.7). FWB also showed a significant time effect (p=.001) and interaction of time and treatment (p<.002). FWB in G300 improved by T2, with no additional improvement at T3; it was unchanged in G900 at T2 with a slight reduction at T3; PL showed a modest improvement at T2 followed by a modest worsening at T3 (PL - T1 17.8, T2 18.1, T3 17.9; G300 - T1 17.9, T2 18.6, T3 18.6; G900 - T1 18.6, T2 18.6, T3 18.5). Conclusions: As reported previously, G900 is effective in reducing hot flashes. In this analysis, however, PWB and FWB showed different patterns of change over time between the two gabapentin and placebo groups with G900 showing minimal effects on PWB and FWB. Future trials to further study the changes in physical and functional well-being of women with breast cancer taking gabapentin for hot flashes are needed.
A phase I/II study of LDE225, a smoothened (Smo) antagonist, in pediatric patients with recurrent medulloblastoma (MB) or other solid tumors.
Authors: Geoerger Birgit , Aerts Isabelle , Casanova Michela , Chisholm Julia C. , Hargrave Darren R , Leary Sarah , Ashley David M , Bouffet Eric , MacDonald Tobey , Hurh Eunju , Dey Jyotirmoy , Kalambakas Stacey , Amakye Dereck Dokyi , Kieran Mark W. 
Published: March 2020

9519 Background: Hedgehog (Hh) signaling is crucial in the development and homeostasis of many human organs and tissues. Aberrant Hh signaling is involved in tumorigenesis through promotion of cell proliferation, survival, and differentiation in wide range of human cancers, including approximately 30% of MBs. LDE225 is a potent and selective inhibitor of Smo, a key positive regulator of Hh signaling. The phase I is exploring the safety and pharmacokinetics of LDE225 in pediatric patients with advanced solid tumors that are potentially dependent on Hh signaling. Preliminary data from the ongoing phase I are presented. Methods: Dose-escalation was performed according to a Bayesian design starting at 372 mg/m2 of continuous once daily oral LDE225. Safety and preliminary efficacy of LDE225 at the maximum tolerated dose will be assessed in pediatric and adult patients with recurrent MB in a phase II expansion part. Pharmacokinetic profiles were performed at Day 1 and 21. Tumor samples were analyzed for Hh pathway activation status using a 5-gene Hh signature assay. Results: Thirty-three patients (24 MB, 3 rhabdomyoscarcoma [RMS], 3 osteosarcoma, and 1 each of neuroblastoma, gliomatosis and oligoastrocytoma) with a median age of 13 years (range, 4–17 y) have enrolled. Dose-limiting toxicity of Grade 4 creatine phosphokinase elevation occurred in 1 RMS patient out of 7 patients treated at 372 mg/m2. No dose-limiting toxicity was observed at 233 and 425 mg /m2. LDE225 at 233 and 372 mg/m2 was absorbed with a median Tmax of 2 h (range, 1–24 h). Systemic exposures were comparable with adults. Two MB patients achieved a confirmed complete response (CR) at doses of 372 and 425 mg/m2. Analysis of 14 available MB tumor samples using the 5-gene Hh signature assay showed that the 2 CR patients have Hh‑activated tumor. The remaining 12 tumor samples were from patients who did not achieve response and were determined to be Hh pathway non-activated. Conclusions: LDE225 is well tolerated in pediatric patients with advanced malignancies. Preliminary data show promising efficacy in medulloblastoma patients and support the use of the 5-gene Hh signature assay as a pre-selection tool in future trials.
Outcome of 116 cases of pleuropulmonary blastoma type I and type Ir (regressed): A report from the International PPB Registry (IPPBR).
Authors: Messinger Yoav H. , Williams Gretchen M , Priest John R. , Harris Anne , Doros Leslie Ann , Schultz Kris Ann Pinekenstein , Dehner Louis P , Hill D Ashley 
Published: March 2020

9522 Background: Pleuropulmonary blastoma (PPB) is a rare dysembryonic lung neoplasm of early childhood with progression from a purely cystic Type I (T-I) lesion to cystic solid and solid high grade sarcoma (Type II and Type III). A regressed form of PPB (T-Ir) has been recognized pathologically. The outcome of both T-I and T-Ir has been only partially described. Methods: Retrospective analysis of 345 IPPBR cases showed 116 T-I or T-Ir. In all cases the PPB diagnosis was made on surgically removed cysts. The treating physician decided whether to use chemotherapy after surgery. Results: The pathologic diagnosis of the 91 PPB T-I and 25 T-Ir is now confirmed by central review (LPD and DAH). Patients with T-I were younger than T-Ir (median: 8 months vs. 48 months).Diagnosis after age 6 years included only one T-I compared to 10 T-Ir patients. Therapy is not known for 28 T-I and 2 T-Ir. Surgery was followed by chemotherapy in 31 T-I and 2 T-Ir. Six (5%) recurred with the same type, all were alive at last follow-up: 5 (5.5%) T-I, 1 (4%) T-Ir. Progression to high-grade Type II or III occurred in 9/91 (10%) T-I and 2/25 (8%) T-Ir. The addition of chemotherapy did not significantly reduce progressions (Fisher’s exact test). All of the tumor progressions were seen by 75 months of age; this finding is similar to broader IPPBR data: > 95% of patients are diagnosed with Type II/III by 72 months of age. Of the 9 patients with T-I who progressed, 5 ultimately died, whereas the 2 T-Ir who progressed were alive. At last follow-up 111/116 (95.6%) were alive. Conclusions: A cyst in an older individual most likely will be Type Ir. Type I and Type Ir are clinically similar with a small risk of progression to the advanced Type II/III up to 6 years of age. Outcome for those whose cystic PPBs progressed is poor. The role of chemotherapy remains uncertain for the prevention of progression in the pure cystic PPB Type I or Ir. [Table: see text]