A phase III randomized study comparing the effects of oxandrolone (Ox) and megestrol acetate (Meg) on lean body mass (LBM), weight (wt) and quality of life (QOL) in patients with solid tumors and weight loss receiving chemotherapy

2008 ◽  
Vol 26 (15_suppl) ◽  
pp. 9513-9513 ◽  
Author(s):  
G. J. Lesser ◽  
D. Case ◽  
F. Ottery ◽  
R. McQuellon ◽  
J. K. Choksi ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Weight Loss ◽  
Solid Tumors ◽  
Lean Body Mass ◽  
Body Mass ◽  
Randomized Study ◽  
Megestrol Acetate ◽  
Phase Iii

scholarly journals Associations between safety, tolerability, and toxicity and the reporting of health‐related quality of life in phase III randomized trials in common solid tumors

2020 ◽  
Vol 9 (21) ◽  
pp. 7888-7895
Author(s):  
Ramy R. Saleh ◽  
Nicholas Meti ◽  
Domen Ribnikar ◽  
Hadar Goldvaser ◽  
Alberto Ocana ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Solid Tumors ◽  
Randomized Trials ◽  
Phase Iii ◽  
Health Related Quality ◽  
Related Quality ◽  
Health Related

PROSPER: A phase III randomized study comparing perioperative nivolumab (nivo) versus observation in patients with localized renal cell carcinoma (RCC) undergoing nephrectomy (ECOG-ACRIN 8143).

2019 ◽  
Vol 37 (7_suppl) ◽  
pp. TPS684-TPS684 ◽  
Author(s):  
Lauren Christine Harshman ◽  
Maneka Puligandla ◽  
Naomi B. Haas ◽  
Mohamad Allaf ◽  
Charles G. Drake ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Overall Survival ◽  
Immune System ◽  
Clinical Outcomes ◽  
Clinical Stage ◽  
Randomized Study ◽  
Phase Iii ◽  
The Impact ◽  
Metastatic Rcc

TPS684 Background: The anti-PD-1 antibody nivo improves overall survival in metastatic RCC and is well tolerated. There is no standard adjuvant systemic therapy that increases overall survival (OS) over surgery alone for non-metastatic RCC. Priming the immune system prior to surgery with anti-PD-1 has shown an OS benefit compared to a pure adjuvant approach in mouse solid tumor models. The PROSPER RCC trial aims to improve clinical outcomes by priming the immune system prior to nephrectomy with neoadjuvant nivo and continued engagement with adjuvant blockade in patients with high risk M0 RCC compared to surgery alone. Methods: This global, unblinded, phase 3 National Clinical Trials Network study is currently accruing patients with clinical stage ≥T2 or node positive M0 RCC of any histology. Tumor biopsy prior to randomization is mandatory to ensure RCC and permits in depth correlative science. The investigational arm will receive two doses of nivo 240mg prior to surgery followed by adjuvant nivo for 9 months (q2 wks x 3 mo followed by 480mg q4 wks x 6 mo). The control arm will undergo standard nephrectomy followed by observation. Randomized patients are stratified by clinical T stage, node positivity, and histology. To enhance accrual and patient quality of life, key upcoming amendments are being instituted. These include biopsy only in the nivo arm, allowance of oligometastatic disease and bilateral renal masses that can be fully resected/ablated, and change of nivo dosing to q4 wks (1 neoadj; 9 adj). With accrual of 766 patients, there is 84.2% power to detect a 14.4% absolute benefit in recurrence-free survival (RFS) at 5 years assuming the ASSURE historical control of ~56% to 70% (HR = 0.70). The study is also powered to evaluate a significant increase in overall survival (HR 0.67). Safety, feasibility, and quality of life endpoints critical to adjuvant therapy considerations are incorporated. PROSPER RCC embeds a wealth of translational work aimed at investigating the impact of the baseline immune milieu, the changes induced by neoadjuvant anti-PD-1 priming, and how both correlate with clinical outcomes. Clinical trial information: NCT03055013.

scholarly journals Testosterone replacement therapy of opioid-induced male hypogonadism improved body composition but not pain perception: a double-blind, randomized, and placebo-controlled trial

2020 ◽  
Vol 182 (6) ◽  
pp. 539-548 ◽  
Author(s):  
Dorte Glintborg ◽  
Henrik Bjarke Vaegter ◽  
Louise Lehmann Christensen ◽  
Emma Bendix ◽  
Thomas Graven-Nielsen ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Body Composition ◽  
Lean Body Mass ◽  
Body Mass ◽  
Fat Mass ◽  
Pain Perception ◽  
Adrenal Function ◽  
Total Testosterone ◽  
Double Blind

Background Hypogonadism is prevalent during opioid treatment, but the effect of testosterone replacement treatment (TRT) on body composition, pain perception, and adrenal function is unclear. Purpose To measure changes in body composition, pain perception, quality of life, and adrenal function after TRT or placebo in opioid-treated men with chronic non-malignant pain. Methods Double-blind, placebo-controlled study in 41 men (>18 years) with total testosterone <12 nmol/L were randomized to 24 weeks TRT (Testosterone undecanoate injection three times/6 months, n = 20) or placebo (placebo-injections, n = 21). Outcomes Body composition (lean body mass and fat mass assessed by DXA), clinical pain intensity (numerical rating scale), and experimental pain perception (quantitative sensory assessment), quality of life (SF36), and adrenocorticotrophic hormone (ACTH) test. Data were presented as median (quartiles). Mann–Whitney tests were performed on delta values (24–0 weeks) between TRT and placebo. Results The median age was 55 years (46; 59) and total testosterone before intervention was 6.8 (5.0; 9.3) nmol/L. TRT was associated with change of testosterone levels: 12.3 (7.0; 19.9) nmol/L (P < 0.001 vs placebo), increased lean body mass: 3.6 (2.3; 5.0) kg vs 0.1 kg (−2.1; 1.5) during TRT vs placebo and decreased total fat mass: −1.2 (−3.1; 0.7) kg vs 1.2 kg (−0.9; 2.5) kg, both P < 0.003. Changed pain perception, SF36, and ACTH-stimulated cortisol levels were non-significantly changed during TRT compared with placebo. Conclusions Six months of TRT improved body composition in men with opioid-induced hypogonadism without significant changes in outcomes of pain perception, quality of life, or adrenal function.

scholarly journals Systemic Changes in Patients with Chronic Obstructive Pulmonary Disease (COPD): Two Years of Follow-up

2007 ◽  
Vol 30 (3) ◽  
pp. 38
Author(s):  
Roxana G. Galesanu ◽  
Sarah Bernard ◽  
Jean Bourbeau ◽  
Annie Michaud ◽  
François Maltais
Keyword(s):  
Quality Of Life ◽  
Clinical Outcomes ◽  
Lean Body Mass ◽  
Body Mass ◽  
Walking Distance ◽  
Inflammatory Status ◽  
Arterial Blood ◽  
Systemic Manifestations

Background: There is a lack of information concerning the natural evolution of the systemic manifestations related to COPD. The aim of this study was to observe the evolution of the systemic manifestations (muscle wasting, inflammation) related to COPD over a two-year period and to assess their relationships with clinical outcomes (exacerbations and worsening in quality of life) in a longitudinal prospective cohort. Methods: Forty-eight patients with COPD (FEV1: 42 ± 14 % predicted, lean mass: 49 ± 10 kg, 6-min walking distance: 422 ± 112 m, total SGRQ score: 45 ± 17) were included. Baseline and annual follow-up for body composition by DEXA scan, blood cytokines (CRP, IL-6), arterial blood gases, pulmonary function tests and quality of life were obtained. The number of acute exacerbations was recorded. Results: Overall, FEV1, lean body mass, 6-min walking distance and blood inflammatory markers did not change over the two years. During this time, the SGRQ scores decreased by 4 ± 11 points (P=0.021) and 2.7 ± 2.4 exacerbations per patient were observed. There was no relationship between the changes in physiological measures and the fall in SGRQ or the exacerbation rate. A loss in lean body mass > 3% was observed in 11 (23%) patients but this was not associated with any adverse clinical outcomes nor with further loss in FEV1, walking distance and inflammatory status. Conclusion: This cohort of patients remained remarkably stable over a 2-year follow-up period. A small loss in lean body mass was observed in some patients but this could not be associated with adverse clinical outcomes during this period.

scholarly journals Changes in Body Mass Index and Quality of Life—Population-Based Follow-up Study COURAGE and COURAGE-POLFUS, Poland

2019 ◽  
Author(s):  
Katarzyna Zawisza ◽  
Beata Tobiasz-Adamczyk ◽  
Aleksander Galas ◽  
Katarzyna Jabłońska ◽  
Tomasz Grodzicki
Keyword(s):  
Quality Of Life ◽  
Body Mass Index ◽  
Weight Loss ◽  
Body Mass ◽  
Population Level ◽  
Population Based ◽  
Population Based Study ◽  
Weight Loss Programs

Abstract The study aimed to verify an association between changes in body mass index (BMI) and quality of life (QoL) in a 4-year follow-up in a population-based study in Poland. The results covered data from 1557 adults from the general Polish population who participated in the follow-up survey, performed in two waves: 2011 (COURAGE in Europe); 2015/2016 (COURAGE-POLFUS). Anthropometric measurements and a structured questionnaire including the WHOQOL-AGE scale were used. Regression models were applied to verify whether the observed BMI–QoL association is linear or U-shaped. The inverse U-shaped association between BMI changes and QoL among Polish adults was found using a univariable model. This association was observed in women, whereas in men a linear relationship was found. At the population level, weight loss (BMI decrease of 5–10%) was associated with better QoL in healthy people. The reverse was true in sick people, whose weight loss was observed to be an indicator of poorer QoL. In conclusion, the study suggests an inverse U-shaped association between BMI and quality of life. Better QoL may be considered an additional benefit of public weight loss programs for healthy adults. Further studies focusing on people with some chronic diseases are needed.

PROSPER: A phase III randomized study comparing perioperative nivolumab (nivo) versus observation in patients with renal cell carcinoma (RCC) undergoing nephrectomy (ECOG-ACRIN 8143).

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. TPS4597-TPS4597 ◽  
Author(s):  
Lauren Christine Harshman ◽  
Maneka Puligandla ◽  
Naomi B. Haas ◽  
Mohamad Allaf ◽  
Charles G. Drake ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Immune System ◽  
Clinical Outcomes ◽  
Clinical Stage ◽  
Randomized Study ◽  
Phase Iii ◽  
Perioperative Therapy ◽  
The Impact ◽  
Metastatic Rcc

TPS4597 Background: The anti-PD-1 antibody nivo improves overall survival (OS) in metastatic RCC and is well tolerated. There is no standard adjuvant (adjuv) systemic therapy that increases OS over surgery alone for non-metastatic RCC. Priming the immune system prior to surgery with anti-PD-1 has shown an OS benefit compared to a pure adjuv approach in mouse solid tumor models. Multiple ph 2 studies in bladder, lung and breast cancers have shown remarkable pathologic responses with neoadjuvant (neoadj) PD-1 blockade. Two ongoing ph 2 studies of perioperative nivo in M0 RCC patients are showing preliminary feasibility and safety with no surgical delays (NCT02575222; NCT02595918). PROSPER RCC (NCT03055013) aims to improve clinical outcomes by priming the immune system prior to nephrectomy with neoadj nivo and continued engagement with adjuv blockade in patients with high risk RCC compared to surgery alone. Methods: This global, unblinded, phase 3 National Clinical Trials Network study is currently accruing patients with clinical stage ≥T2 or TanyN+ RCC of any histology planned for nephrectomy. Oligometastases are permitted if can be rendered NED. We amended the study to enhance accrual and patient quality of life by changing nivo dosing to 480mg q4 wks and requiring baseline tumor biopsy only in the nivo arm. The investigational arm receives 1 dose of nivo prior to surgery followed by 9 adjuv doses. The control arm undergoes standard nephrectomy followed by observation. Randomized patients are stratified by clinical T stage, node positivity, and M stage. Accrual of 805 patients provides 84.2% power to detect a 14.4% absolute benefit in recurrence-free survival (RFS) at 5 years assuming the ASSURE historical control of ~56% to 70% (HR = 0.70). The study is powered to evaluate a significant increase in OS (HR 0.67). Critical perioperative therapy considerations such as safety, feasibility, and quality of life endpoints have been integrated. PROSPER RCC embeds a wealth of translational work aimed at investigating the impact of the baseline immune milieu, the changes induced by neoadjuvant anti-PD-1 priming, and how both may predict clinical outcomes. Clinical trial information: NCT03055013.

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