Influence of early-phase clinical trial enrollment on patterns of end-of-life care for children with advanced cancer.

2016 ◽  
Vol 34 (26_suppl) ◽  
pp. 151-151 ◽  
Author(s):  
Prasanna Janaki Ananth ◽  
Chalinee Monsereenusorn ◽  
Clement Ma ◽  
Hasan Al-Sayegh ◽  
Joanne Wolfe ◽  
...  
Keyword(s):  
Advanced Cancer ◽  
Early Phase ◽  
Hospital Admissions ◽  
Medical Procedures ◽  
Early Phase Clinical Trial ◽  
Phase Clinical Trial ◽  
Clinical Trial Enrollment ◽  
Early Phase Clinical Trials ◽  
Eol Care ◽  
Clinic Visits

151 Background: Early phase clinical trials are critical to enhancing therapies for children with advanced cancer. However, trial enrollment may intensify end-of-life (EOL) care. We evaluated patterns of EOL care for patients at a large cancer center. Methods: Single-center, retrospective cohort study of pediatric oncology patients, ages 6 months-21 years, who died in 2010-2014. We queried electronic medical records to assess frequencies of medical procedures (e.g. intubations), clinic visits, and hospital admissions in the last 6 months of life. We assessed timing of pediatric palliative care (PPC) consultation, initial advance care planning (ACP) discussion, and entry of do-not-attempt resuscitation (DNAR) orders in the chart, in relation to date of death. Patients enrolled in early phase clinical trials for at least 1 cycle (EP) were compared with those not enrolled (NEP), using Wilcoxon rank sum and Fisher exact tests. Results: For N = 125 patients, median age at death was 11.6 years (IQR 5.8-16.3); 46% were female; 70% were White, non-Hispanic. 26% were trial enrollees. Diagnoses included 42% solid tumors, 41% brain tumors, and 18% hematologic malignancies. Most patients had PPC consultation (83%), ACP discussions (91%), and DNAR orders (86%). EP and NEP cohorts did not significantly differ in baseline demographic or clinical characteristics, frequencies of medical procedures, or hospital admissions. EP patients had a higher median number of clinic visits than NEP patients (18.5 [16.3-27.2] vs. 14.1 [6.5-20.7], p = 0.0003) and received PPC consultation significantly closer to death than NEP patients (median days before death = 58 [16-84] vs. 85 [32-173], p = 0.04). There was no difference between EP and NEP patients in timing of initial ACP discussion or of DNAR order entry. Conclusions: Near the EOL, EP patients had more frequent clinic visits and later PPC consultation, but trial enrollment did not appear to delay ACP discussions or increase hospital resource use. These results suggest that early phase clinical trial enrollment does not substantially alter EOL care patterns for children with advanced cancer.

Influence of early phase clinical trial enrollment on patterns of end-of-life care for children with advanced cancer

2017 ◽  
Vol 65 (1) ◽  
pp. e26748 ◽  
Author(s):  
Prasanna Ananth ◽  
Chalinee Monsereenusorn ◽  
Clement Ma ◽  
Hasan Al-Sayegh ◽  
Joanne Wolfe ◽  
...  
Keyword(s):  
Clinical Trial ◽  
End Of Life ◽  
Advanced Cancer ◽  
End Of Life Care ◽  
Early Phase ◽  
Life Care ◽  
Early Phase Clinical Trial ◽  
Phase Clinical Trial ◽  
Clinical Trial Enrollment

Compliance with dietary guidelines and its relationship with symptoms and clinical outcomes in patients with advanced cancer in early-phase oncology clinical trials.

2021 ◽  
Vol 39 (28_suppl) ◽  
pp. 199-199
Author(s):  
Goldy George ◽  
Alan J Kim ◽  
Melat Gebremeskel ◽  
Meryna Manandhar ◽  
Harsha M Pradeep ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Advanced Cancer ◽  
Early Phase ◽  
Symptom Burden ◽  
Whole Grains ◽  
Dietary Guidelines ◽  
Early Phase Clinical Trial ◽  
Dietary Guidelines For Americans ◽  
Phase Clinical Trial

199 Background: We examined compliance with the Dietary Guidelines for Americans and its association with symptom burden and clinical outcomes in patients with advanced cancer in early-phase clinical trials testing novel immunotherapeutic and targeted agents. Methods: Patients starting an early-phase clinical trial (ECOG-PS = 0-1) were recruited into a prospective, longitudinal design with assessments at baseline and at the end of Cycle 1. Diet and symptom burden were assessed using the validated National Cancer Institute Diet History Questionnaire (NCI-DHQ) and the MD Anderson Symptom Inventory, respectively. Compliance with the Dietary Guidelines for Americans recommendations was measured via the Healthy Eating Index (HEI) (a measure of dietary intake per total energy), computed from NCI-DHQ food group and nutrient scores; higher HEI scores indicate greater compliance with dietary guidance recommendations (possible range = 0–100). Statistical tests included Spearman rank correlations (rho), and Cox proportional hazards models. Results: Among early-phase clinical trial patients [N = 40; 50% female; 80% Non-Hispanic White; 80% ECOG = 1; 36% on trials including an immunotherapeutic agent and 64% on targeted therapy trials; mean age = 55y; mean BMI = 28], mean HEI was 69, compared to 59 for the US general population. The proportion of phase I clinical trial patients who met adequacy guidelines were 80% for whole fruit, 73% for total protein foods, 55% for seafood and plant proteins, 55% for total fruit, 50% for greens and beans, 28% for total vegetables, 15% for fatty acids [(PUFAs + MUFAs)/SFAs ≥2.5], 13% for dairy, and 0% for whole grains. The proportion of patients who met moderation guidelines were 28% for refined grains, 28% for added sugar, 13% for saturated fat, and 0% for sodium. Female patients had higher HEI scores than male patients (73 vs. 65, P = 0.004). Patients who were normal weight (BMI < 25) had higher scores for meeting the moderation in sugar intake guideline than overweight patients (BMI≥25) (7.7 vs. 5.5, P = 0.031). Higher intakes of cooked lean meat from beef, pork, veal, lamb, and game were linked to prolonged overall survival (HR = 0.5, 95%CI = 0.26, 0.96, P = 0.039). In immunotherapy patients, greater compliance with seafood and plant protein recommendations was associated with less fatigue at end of Cycle 1 (rho = -0.7, P = 0.008); in targeted therapy patients, higher glycemic load was associated with worse pain (rho = 0.7, P = 0.004). Conclusions: Diets of these early-phase clinical trial patients overall were congruent with recommendations in the Dietary Guidelines for Americans. However, increasing intakes of whole grains and reducing sodium intakes may be useful dietary goals for this population. Also, dietary factors may influence symptoms, such as fatigue and pain, in early-phase clinical trial patients with advanced cancer.

Interest in initiating an early phase clinical trial: results of a longitudinal study of advanced cancer patients

2016 ◽  
Vol 26 (10) ◽  
pp. 1604-1610 ◽  
Author(s):  
Laura B. Dunn ◽  
Jim Wiley ◽  
Sarah Garrett ◽  
Fay Hlubocky ◽  
Christopher Daugherty ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Longitudinal Study ◽  
Cancer Patients ◽  
Advanced Cancer ◽  
Early Phase ◽  
Advanced Cancer Patients ◽  
Early Phase Clinical Trial ◽  
Phase Clinical Trial ◽  
Clinical Trial Results

scholarly journals Psilocybin: From Serendipity to Credibility?

2021 ◽  
Vol 12 ◽  
Author(s):  
James J. Rucker ◽  
Allan H. Young
Keyword(s):  
Early Phase ◽  
Clinical Trial Data ◽  
Nuremberg Code ◽  
Treatment Development ◽  
Early Phase Clinical Trial ◽  
Early Phase Trials ◽  
History Of ◽  
Phase Clinical Trial ◽  
Early Phase Clinical Trials ◽  
Do So

Psilocybin has a long history of non-medical use and some seem to infer from this that it has therapeutic utility. Early phase clinical trials with psilocybin are encouraging, but suggest only that larger, multicentre trials are required. These are ongoing but will take many years to complete. Meanwhile, retreat centers offering paid experiences with psilocybin truffles have opened in some countries, often using early phase clinical trial data as a basis for bold, public facing claims. This seems unwise. Early phase trials are not designed for their results to be generalized outside the setting they were undertaken in. To do so risks being misleading. Providing what may be seen as an unregulated drug intervention as a paid service is difficult to reconcile with long-held ethical principles underpinning human research and treatment development that were laid down by the 1947 Nuremberg Code and the 1962 Kefauver Harris Amendments. By using psilocybin before it has been properly tested, retreat centers may be undermining their own credibility and the credibility of the wider field.

scholarly journals Molecular profiling of metastatic bladder cancer early-phase clinical trial participants predicts patient outcomes

2020 ◽  
pp. molcanres.0751.2020
Author(s):  
Omar Alhalabi ◽  
Andrew W Hahn ◽  
Pavlos Msaouel ◽  
Alexander Y Andreev-Drakhlin ◽  
Funda Meric-Bernstam ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Bladder Cancer ◽  
Patient Outcomes ◽  
Early Phase ◽  
Molecular Profiling ◽  
Early Phase Clinical Trial ◽  
Metastatic Bladder Cancer ◽  
Phase Clinical Trial ◽  
Trial Participants

scholarly journals Realizing better doctor-patient dialogue about choices in palliative care and early phase clinical trial participation: towards an online value clarification tool (OnVaCT)

2019 ◽  
Vol 18 (1) ◽  
Author(s):  
Liza G. G. van Lent ◽  
Nicole K. Stoel ◽  
Julia C. M. van Weert ◽  
Jelle van Gurp ◽  
Maja J. A. de Jonge ◽  
...  
Keyword(s):  
Decision Making ◽  
Clinical Trials ◽  
Advanced Cancer ◽  
Early Phase ◽  
Decisional Conflict ◽  
Decision Making Process ◽  
Medical Oncologists ◽  
Post Test ◽  
Patient Values ◽  
Early Phase Clinical Trials

Abstract Background Patients with advanced cancer for whom standard systemic treatment is no longer available may be offered participation in early phase clinical trials. In the decision making process, both medical-technical information and patient values and preferences are important. Since patients report decisional conflict after deciding on participation in these trials, improving the decision making process is essential. We aim to develop and evaluate an Online Value Clarification Tool (OnVaCT) to assist patients in clarifying their values around this end-of-life decision. This improved sharing of values is hypothesized to support medical oncologists in tailoring their information to individual patients’ needs and, consequently, to support patients in taking decisions in line with their values and reduce decisional conflict. Methods In the first part, patients’ values and preferences and medical oncologists’ views hereupon will be explored in interviews and focus groups to build a first prototype OnVaCT using digital communication (serious gaming). Next, we will test feasibility during think aloud sessions, to deliver a ready-to-implement OnVaCT. In the second part, the OnVaCT, with accompanied training module, will be evaluated in a pre-test (12–18 months before implementation) post-test (12–18 months after implementation) study in three major Dutch cancer centres. We will include 276 patients (> 18 years) with advanced cancer for whom standard systemic therapy is no longer available, and who are referred for participation in early phase clinical trials. The first consultation will be recorded to analyse patient-physician communication regarding the discussion of patients’ values and the decision making process. Three weeks afterwards, decisional conflict will be measured. Discussion This project aims to support the discussion of patient values when considering participation in early phase clinical trials. By including patients before their first appointment with the medical oncologist and recording that consultation, we are able to link decisional conflict to the decision making process, e.g. the communication during consultation. The study faces challenges such as timely including patients within the short period between referral and first consultation. Furthermore, with new treatments being developed rapidly, molecular stratification may affect the patient populations included in the pre-test and post-test periods. Trial registration Netherlands Trial Registry number: NTR7551 (prospective; July 17, 2018).

scholarly journals An Inflammation Based Score Can Optimize the Selection of Patients with Advanced Cancer Considered for Early Phase Clinical Trials

PLoS ONE ◽  
2014 ◽  
Vol 9 (1) ◽  
pp. e83279 ◽  
Author(s):  
David J. Pinato ◽  
Chara Stavraka ◽  
Michael J. Flynn ◽  
Martin D. Forster ◽  
Séan M. O'Cathail ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Advanced Cancer ◽  
Early Phase ◽  
Early Phase Clinical Trials ◽  
Selection Of Patients ◽  
Selection Of

Effective targeted antitumor activity of the antimicrobial agent taurolidine against relapsed/refractory neuroblastoma: Cytotoxicity, target modulation and tumor xenograft studies.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e21502-e21502
Author(s):  
Lucy Swift ◽  
Chunfen Zhang ◽  
Antony Pfaffle ◽  
Paul Chew ◽  
Olga Kovalchuk ◽  
...  
Keyword(s):  
Gene Expression ◽  
Clinical Trial ◽  
Early Phase ◽  
Phase Contrast ◽  
Time Lapse ◽  
Early Phase Clinical Trial ◽  
Phase Clinical Trial ◽  
Time Lapse Video

e21502 Background: Neuroblastoma (NB) is the most common extracranial solid tumor and one of the most complex and difficult to treat diseases in pediatrics. Currently, even with highly aggressive treatment protocols, the prognosis for patients with high-risk and relapsed NB remains poor. Hence, there is a clear need to identify new agents and novel therapeutic strategies for the treatment of these children. Taurolidine (TRD) is derived from the aminosulfoacid taurine and has known anti-microbial and anti-inflammatory properties. TRD has demonstrated anti-neoplastic activity against a range of aggressive human tumors. We present mechanistic evidence and supportive preclinical data from in vitro and animal models of refractory NB for the development of an early phase clinical trial incorporating TRD. Methods: For in vitro activity studies, a panel of cell lines derived from patients with relapsed NB (n = 6) and normal control cells were treated with increasing concentrations of TRD and cell viability was measured by alamar blue assay. Phase-contrast light microscopy, western blotting, time-lapse video microscopy and analysis of global gene expression by RNA-Seq were used to evaluate target modulation and induction of cell death pathways. Bioluminescence imaging of mice bearing NB xenografts treated with TRD was used to investigate the efficacy of TRD in vivo. Results: Cell survival data showed that TRD is cytotoxic against NB cell lines in vitro (mean IC50 value 100 µM, range 65-135 µM). Phase-contrast and time-lapse video microscopy confirmed the antitumor effects of TRD. Western blot analyses identified that TRD induced target modulation and an effective apoptotic cascade, resulting in PARP cleavage. Gene expression analyses and signaling pathway activation scores indicated alterations in the Notch, MAPK and IL-10 signaling pathways. Xenograft studies further validated the in vivo activity of TRD with decreased tumor burden in treated mice and a measurable improvement in survival. Conclusions: Our study provides key pre-clinical data on the activity and mechanism of action of TRD against NB. The findings support the rationale for further evaluation of TRD for the treatment of relapsed/refractory NB patients in an early phase clinical trial.

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