Pharmacological management update: clinical significance of anamorelin clinical trials for the treatment of cancer cachexia in advanced cancer patients

2016 ◽  
Vol 5 (S3) ◽  
pp. S491-S496
Author(s):  
Terence Rong De Ng ◽  
Eduardo Bruera ◽  
Sriram Yennurajalingam
Keyword(s):  
Clinical Trials ◽  
Cancer Patients ◽  
Clinical Significance ◽  
Advanced Cancer ◽  
Cancer Cachexia ◽  
Advanced Cancer Patients ◽  
Pharmacological Management

Individual Meaning-Centered Psychotherapy for Advanced Cancer Patients

2017 ◽  
Author(s):  
William Breitbart ◽  
Wendy G. Lichtenthal ◽  
Allison J. Applebaum ◽  
Melissa Masterson
Keyword(s):  
Clinical Trials ◽  
End Of Life ◽  
Cancer Patients ◽  
Advanced Cancer ◽  
Therapeutic Intervention ◽  
Well Being ◽  
Existential Psychology ◽  
Advanced Cancer Patients ◽  
Spiritual Well Being ◽  
Existential Concerns

Among the advanced cancer population, existential concerns are major issues that promote significant distress. For patients who are facing death, meaning and the preservation of meaning are not only clinically and existentially important but also central concepts to a therapeutic intervention. Based on Viktor Frankl’s logotherapy and the principles of existential psychology and philosophy, “meaning-centered psychotherapy” was developed to help patients with advanced cancer sustain or enhance a sense of meaning, peace, and purpose in their lives. This chapter provides an overview of work developing and testing individual meaning-centered psychotherapy (IMCP). It provides an overview of the session content in the IMCP intervention. It also presents findings from clinical trials, which support the efficacy of IMCP as an intervention to increase a sense of meaning, spiritual well-being, and hope while decreasing end-of-life despair. Furthermore, it presents difficult scenarios that may arise when delivering IMCP for clinicians interested in this work.

Placebo and nocebo effects in randomized double-blind clinical trials for fatigue in advanced cancer patients

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 9640-9640
Author(s):  
M. de la Cruz ◽  
D. Hui ◽  
H. A. Parsons ◽  
P. Lynn ◽  
C. Parker ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Side Effects ◽  
Cancer Patients ◽  
Advanced Cancer ◽  
Randomized Clinical Trials ◽  
Placebo Response ◽  
Well Being ◽  
Advanced Cancer Patients ◽  
Edmonton Symptom Assessment Scale ◽  
Nocebo Effects

9640 Background: We have previously reported significant placebo response in randomized controlled treatment trials for cancer related fatigue (CRF). We conducted a retrospective study to determine the frequency and predictors of response to placebo and nocebo effect in patients with CRF. Methods: We reviewed patients that received placebo in two previous randomized clinical trials conducted by our group and determined the proportion of patients who demonstrated clinical response to fatigue using an increase (ΔFACIT-F score) > 7 from baseline to day 8, and those with nocebo response as those who reported side effects. Baseline patient characteristics and symptoms recorded from the Edmonton Symptom Assessment Scale (ESAS) were analyzed to determine their association with placebo and nocebo effects. Results: A total of 105 advanced cancer patients received placebo. 59 (56%) patients responded to placebo (median Δ FACIT-F score of 22). Worse baseline anxiety and well-being subscale score (univariate) and well-being (multivariate, MR) were significantly associated with placebo response. Common side effects reported were insomnia (79%), anorexia (53%), nausea (38%) and restlessness (34%). MR analysis showed that worse baseline (ESAS) sleep, appetite, nausea, and restless are associated with increased reporting of these side effects ( Table ). Conclusions: Nearly half of advanced cancer patients enrolled in the fatigue trials responded to placebo. Worse physical well-being score was associated with placebo response. Patients experiencing specific symptoms at baseline were more likely to report these as side effects of the medication. These findings should be considered in fatigue clinical trial design. [Table: see text] No significant financial relationships to disclose.

scholarly journals Impact of the timing of tumor assessments on median progression-free survival in clinical trials in advanced cancer patients

ESMO Open ◽  
2022 ◽  
Vol 7 (1) ◽  
pp. 100366
Author(s):  
T. Samaille ◽  
C. Moreau Bachelard ◽  
E. Coquan ◽  
P. du Rusquec ◽  
X. Paoletti ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Cancer Patients ◽  
Advanced Cancer ◽  
Progression Free Survival ◽  
Advanced Cancer Patients ◽  
Free Survival ◽  
Median Progression Free Survival

Development, and Evaluation of a Decision Aid to Support Patients’ Participa-tory Decision-making on Tumor-specific and Palliative Therapy in Advanced Cancer Patients: A Study Protocol. (Preprint)

2020 ◽  
Author(s):  
Katsiaryna Laryionava ◽  
Jan Schildmann ◽  
Michael Wensing ◽  
Ullrich Wedding ◽  
Bastian Surmann ◽  
...  
Keyword(s):  
Health Care ◽  
Decision Making ◽  
Clinical Trials ◽  
Cancer Patients ◽  
Advanced Cancer ◽  
Health Care Providers ◽  
Study Protocol ◽  
Care Providers ◽  
Advanced Cancer Patients ◽  
Design Study

BACKGROUND To support advanced cancer patients, for whom standard therapy is no longer avail-able, and their oncologists in therapy decisions, we aim to develop a decision-making aid (DA) in a multi-phased bicentric study. The DA aims to help patients to better un-derstand risks and benefits of available treatment options including the options of standard palliative care, off-label drug use within an individual treatment plan and involvement in clinical trials. OBJECTIVE This study protocol outlines the development and testing of a DA in a pre-post design study targeting at a heterogeneous population of advanced cancer patients. METHODS In phase I, The DA will be developed after of decisional needs of patients and views of health care providers based on face-to face interviews and focus groups discus-sions. Subsequently, the DA will be alpha-tested and redrafted, as necessary, in phase II. In phase III, the DA will be (1) beta-tested with patients and oncologists and (2) assessed by experts. In the last project phase, we will run a pre-post design study with n= 70 doctor-patient-encounters to access improvements on primary study outcome, i.e. patients’ level of decisional conflict. In addition, the user ac-ceptance will be tested. RESULTS Interviews with cancer patients, oncologists and health care providers have been completed. CONCLUSIONS A unique feature of this study is the development of a DA for patients with different types of advanced cancer, which covers a wide range of topics relevant for patients near the end of life such as forgoing cancer-specific therapy and patients’ inclusion in clinical trials. CLINICALTRIAL NCT04606238 https://clinicaltrials.gov/ct2/show/NCT04606238

Incidence of thromboembolism in patients receiving vorinostat: Clinical trial and post-marketing data from more than 1,800 patients

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e14547-e14547
Author(s):  
S. Rizvi ◽  
J. Lis ◽  
K. Boileau ◽  
J. Garcia-Vargas
Keyword(s):  
Clinical Trials ◽  
Cancer Patients ◽  
Advanced Cancer ◽  
Advanced Cancer Patients ◽  
Serious Adverse Events ◽  
Cutaneous Manifestations ◽  
Post Marketing Surveillance ◽  
The Usa ◽  
Post Marketing ◽  
Marketing Data

e14547 Background: Thromboembolic events (TEEs) occur in approximately 10–15% of advanced cancer patients. Risk factors include cancer therapy and extent and type of malignancy. Vorinostat, a histone deacetylase inhibitor, has been licensed in the USA for the treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma (CTCL) who have progressive, persistent, or recurrent disease on or following two systemic therapies. TEEs were observed in 6/86 patients (7.0%) enrolled in vorinostat CTCL clinical trials at licensure. To gain further insight into the association between TEEs and vorinostat treatment, we analyzed data from vorinostat clinical trials and post-marketing surveillance (PMS) reports. Methods: Serious adverse events (SAEs) reported through November 3, 2008, among patients receiving vorinostat in completed and ongoing clinical trials, PMS reports, and published literature were reviewed for terms consistent with TEEs. A committee of independent (non-Merck employees) academic experts evaluated these reports. Although no safety signals were observed, the committee recommended that d-dimer and/or plasmin-antiplasmin assays should be conducted. This recommendation has been implemented in three ongoing studies ( NCT00486720 , NCT00632931 , NCT006429542) and will provide further information on clotting parameters among patients being treated with vorinostat. Results: During the reporting period, data from >1,845 cancer patients who received vorinostat were reviewed. Irrespective of causality, 107 patients (<5.8%) reported TEE SAEs (Table). Of these, 47 (<2.6%) had TEE SAEs that were rated as related to vorinostat, four of which were fatal. As of the data cut off, review of the special assays in the three studies did not result in any conclusive correlation. Conclusions: The incidence rate of TEEs observed in vorinostat studies is similar to reported rates of TEEs for advanced cancer patients. [Table: see text] [Table: see text]

Patients' perspectives on participation in clinical trials and palliative end-of-life care for management of advanced cancers in Nigeria.

2017 ◽  
Vol 35 (31_suppl) ◽  
pp. 78-78
Author(s):  
Jideuma Ikenna Egwim ◽  
Smita Palejwala
Keyword(s):  
Clinical Trials ◽  
End Of Life ◽  
Cancer Patients ◽  
Advanced Cancer ◽  
End Of Life Care ◽  
Life Care ◽  
Advanced Cancer Patients ◽  
Incurable Cancer ◽  
Quality Of Dying

78 Background: Advanced cancers remain a major cause of mortality in Nigeria. Participation in clinical trials (PCTs) and palliative end-of-life care (PEOLC) are two approaches to incurable cancer management in the developed nations but these have been less adopted in Nigeria. This study set out to determine patients’ preferred approach between PCTs and PEOLC for management of advanced cancers in Nigeria. Methods: A survey of 120 advanced cancer patients was conducted using a questionnaire with 5-point Likert scale, variables of interest included demographic information, knowledge and perception about PCTs and PEOLC. Results: Majority of the patients (84%) agree PCTs is an option in management of incurable cancer but just about half accept it is beneficial and will improve their QOL, as against PEOLC, where all the patients considered it an option and deem it beneficial; with 99% and 98% respectively agreeing it will enhance their QOL and that of family members. About 56% believe PCTs carries a risk of burdensome interventions and 52% increased hospital stay at EOL while 47% are of the opinion it will increase cost of care with 45% stating it will lead to increased ICU death. Sixty-nine percent (69%) and 63% respectively agree PCTs increases the suffering of patients and family members while 43% believe it carries a net negative risk-benefit profile, nevertheless, 83% are ready to overlook the risk of PCTs for possible therapeutic benefit while for 87%, the primary motivation for PCTs is personal cure. Majority (58%) believe PCTs does not improve quality of dying/death contrary to PEOLC where 88% believe it would improve the quality of dying/death. Overall, by direct comparison 78%:13% prefer PEOL to PCTs; {X2(p-value), 40.26(0.001)}. Conclusions: Both modalities are acceptable to advanced cancer patients but the study reveals several ethical issues with PCTs including risk of burdensome interventions, suffering of patients, therapeutic misconception and misperception of curability. A major determinant to accepting PEOL is its positive impact on patients’ QOL. Concerted efforts are needed to significantly enhance access of PEOLC to cancer patients.

Need for nutritional support in advanced cancer patients with cachexia: A survey in palliative care settings.

2017 ◽  
Vol 35 (31_suppl) ◽  
pp. 100-100
Author(s):  
Koji Amano ◽  
Tatsuya Morita ◽  
Jiro Miyamoto ◽  
Teruaki Uno ◽  
Hirofumi Katayama ◽  
...  
Keyword(s):  
Palliative Care ◽  
Parenteral Nutrition ◽  
Cancer Patients ◽  
Advanced Cancer ◽  
Nutritional Support ◽  
Cancer Cachexia ◽  
Tube Feeding ◽  
Advanced Cancer Patients ◽  
Nutrition And Hydration ◽  
To Receive

100 Background: Few studies have investigated the need for nutritional support in advanced cancer patients in palliative care settings.The aim of this survey is to examine the relationship between the need for nutritional support and cancer cachexia, specific needs, perceptions, and beliefs. Methods: We conducted a questionnaire in outpatient service/palliative care teams/palliative care units. Patients were classified into two groups: 1) Non-cachexia/Pre-cachexia and 2) Cachexia/Refractory cachexia. Results: A total of 117 out of 121 patients responded (96.7%). A significant difference was observed in the need for nutritional support between the groups: Non-cachexia/Pre-cachexia (32.7%) and Cachexia/Refractory cachexia (53.6%) (p = 0.031). The specific needs of patients requiring nutritional support were nutritional counseling (93.8%), ideas to improve food intake (87.5%), oral nutritional supplements (83.0%), parenteral nutrition and hydration (77.1%), and tube feeding (22.9%). The top perceptions regarding the best time to receive nutritional support and the best medical staff to provide nutritional support were “when anorexia, weight loss, and muscle weakness become apparent” (48.6%) and “nutritional support team” (67.3%), respectively. The top three beliefs of nutritional treatments were “I do not wish to receive tube feeding” (78.6%), “parenteral nutrition and hydration are essential” (60.7%), and “parenteral hydration is essential” (59.6%). Conclusions: Patients with cancer cachexia had a greater need for nutritional support. Advanced cancer patients wished to receive nutritional support from medical staff with specific knowledge when they become unable to take sufficient nourishment orally and the negative impact of cachexia becomes apparent. Additionally, most patients wished to receive parenteral nutrition and hydration.

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