scholarly journals Deterioration in Muscle Mass and Physical Function Differs According to Weight Loss History in Cancer Cachexia

Cancers ◽  
2019 ◽  
Vol 11 (12) ◽  
pp. 1925 ◽  
Author(s):  
Guro Birgitte Stene ◽  
Trude Rakel Balstad ◽  
Anne Silja M. Leer ◽  
Asta Bye ◽  
Stein Kaasa ◽  
...  
Keyword(s):  
Weight Loss ◽  
Physical Function ◽  
Muscle Mass ◽  
Cancer Cachexia ◽  
Karnofsky Performance Status ◽  
Handgrip Strength ◽  
Controlled Trial ◽  
Performance Status ◽  
Secondary Analysis ◽  
Primary Endpoints

Background: Muscle mass and physical function (PF) are common co-primary endpoints in cancer cachexia trials, but there is a lack of data on how these outcomes interact over time. The aim of this secondary analysis of data from a trial investigating multimodal intervention for cancer cachexia (ClinicalTrials.gov: NCT01419145) is to explore whether changes in muscle mass and PF are associated with weight loss and cachexia status at baseline. Methods: Secondary analysis was conducted using data from a phase II randomized controlled trial including 46 patients with stage III–IV non-small cell lung cancer (n = 26) or inoperable pancreatic cancer (n = 20) due to commence chemotherapy. Cachexia status at baseline was classified according to international consensus. Muscle mass (assessed using computed tomography (CT)) and PF outcomes, i.e., Karnofsky performance status (KPS), self-reported PF (self-PF), handgrip strength (HGS), 6-minute walk test (6MWT), and physical activity (PA), were measured at baseline and after six weeks. Results: When compared according to cachexia status at baseline, patients with no/pre-cachexia had a mean loss of muscle mass (−5.3 cm2, p = 0.020) but no statistically significant change in PF outcomes. Patients with cachexia also lost muscle mass but to a lesser extent (−2.8 cm2, p = 0.146), but demonstrated a statistically significant decline in PF; KPS (−3.8 points, p = 0.030), self-PF (−8.8 points, p = 0.027), and HGS (−2.7 kg, p = 0.026). Conclusions: Weight loss history and cachexia status at baseline are of importance if one aims to detect changes in PF outcomes in cancer cachexia trials. To improve the use of co-primary endpoints that include PF in future trials, outcomes that have the potential to detect change relative to weight loss should be investigated further.

Prevalence and impact of hypogonadism in cancer patients with severe muscle wasting in phase IIb enobosarm trial.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e19582-e19582
Author(s):  
Mitchell S. Steiner ◽  
Adrian Dobs ◽  
Mary Ann Johnston ◽  
Michael L. Hancock ◽  
Ronald A. Morton ◽  
...  
Keyword(s):  
Weight Loss ◽  
Physical Function ◽  
Cancer Patients ◽  
Muscle Wasting ◽  
Controlled Trial ◽  
Performance Status ◽  
Lymphocytic Leukemia ◽  
Double Blind ◽  
Poor Outcomes ◽  
Multi Center Study

e19582 Background: Hypogonadism has been associated with weight loss and poor outcomes in cancer patients. Up to 50% of males with advanced cancer are hypogonadal at presentation or during the course of treatment. Wasting in cancer patients has also been associated with a decline in physical function and performance status and has major public health significance. We conducted a Phase IIb randomized, double blind, placebo controlled, multi-center study to evaluate the effect of enobosarm on muscle wasting and physical function in cancer patients. Methods: Patients (n=159) were randomized to oral enobosarm (1 or 3 mg) or placebo daily for 16 wks. Patients were males >45 y and postmenopausal females, had ≥2% weight loss in the 6 mths prior to randomization, BMI <35 and either NSCLC, colorectal cancer, non-Hodgkins lymphoma, chronic lymphocytic leukemia or breast cancer. We report on the incidence and impact of hypogonadism (T<300 ng/dL) in this population. Results: Baseline testosterone levels were available for 93 of 103 men. 60% of male patients were hypogonadal at randomization. Distribution of hypogonadism was similar across cancers; however hypogonadal men were less likely to complete the study. Baseline T levels were positively correlated with weight loss (r=0.32, p=0.002,) with hypogonadal men demonstrating greater weight loss in the previous six months (median, -9.5%). Baseline physical function as measured by stair climb power was higher among eugonadal males compared to hypogonadal males (84.5 watts vs 70.6 watts; p=0.016). Enobosarm significantly improved physical function in this population regardless of baseline gonadal status (hypogonadal: 18.7%, p=0.0061; eugonadal: 13.2%, p=0.0032). The magnitude of improvement was greater in hypogonadal men. Conclusions: Hypogonadism is common in male cancer patients and is correlated with weight loss and diminished physical function. In this randomized, placebo controlled trial, enobosarm improved physical function in both hypogonadal and eugonadal men despite poorer baseline physical function in hypogonadal patients. These data provide evidence that enobosarm may play an important role in the management of cancer related muscle wasting.

Clinical Dutch-English Lambert-Eaton Myasthenic Syndrome (LEMS) Tumor Association Prediction Score Accurately Predicts Small-Cell Lung Cancer in the LEMS

2011 ◽  
Vol 29 (7) ◽  
pp. 902-908 ◽  
Author(s):  
Maarten J. Titulaer ◽  
Paul Maddison ◽  
Jacob K. Sont ◽  
Paul W. Wirtz ◽  
David Hilton-Jones ◽  
...  
Keyword(s):  
Weight Loss ◽  
Karnofsky Performance Status ◽  
Performance Status ◽  
Age At Onset ◽  
Small Cell ◽  
Prediction Score ◽  
Receiver Operating Curve ◽  
Small Cell Lung ◽  
Myasthenic Syndrome ◽  
Tumor Association

Purpose Approximately one half of patients with Lambert-Eaton myasthenic syndrome (LEMS) have small-cell lung carcinomas (SCLC), aggressive tumors with poor prognosis. In view of its profound impact on therapy and survival, we developed and validated a score to identify the presence of SCLC early in the course of LEMS. Patients and Methods We derived a prediction score for SCLC in LEMS in a nationwide cohort of 107 Dutch patients, and validated it in a similar cohort of 112 British patients. A Dutch-English LEMS Tumor Association Prediction (DELTA-P) score was developed based on multivariate logistic regression. Results Age at onset, smoking behavior, weight loss, Karnofsky performance status, bulbar involvement, male sexual impotence, and the presence of Sry-like high-mobility group box protein 1 serum antibodies were independent predictors for SCLC in LEMS. A DELTA-P score was derived allocating 1 point for the presence of each of the following items at or within 3 months from onset: age at onset ≥ 50 years, smoking at diagnosis, weight loss ≥ 5%, bulbar involvement, erectile dysfunction, and Karnofsky performance status lower than 70. The area under the curve of the receiver operating curve was 94.4% in the derivation cohort and 94.6% in the validation set. A DELTA-P score of 0 or 1 corresponded to a 0% to 2.6% chance of SCLC, whereas scores of 4, 5, and 6 corresponded to chances of SCLC of 93.5%, 96.6%, and 100%, respectively. Conclusion The simple clinical DELTA-P score discriminated patients with LEMS with and without SCLC with high accuracy early in the course of LEMS.

TM1-1 Seizure prophylaxis in gliomas (SPRING): a phase III randomised controlled trial comparing prophylactic levetiracetam versus no prophylactic anti-epileptic drug in glioma surgery

2019 ◽  
Vol 90 (3) ◽  
pp. e8.2-e8
Author(s):  
MD Jenkinson ◽  
C Watts ◽  
AG Marson ◽  
R Hill ◽  
K Murray ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Karnofsky Performance Status ◽  
Controlled Trial ◽  
Performance Status ◽  
Phase Iii ◽  
Glioma Surgery ◽  
Seizure Prophylaxis ◽  
Anti Epileptic Drug ◽  
Seizure Rate ◽  
Randomised Controlled

ObjectivesThere is no consensus regarding the need for prophylactic anti-epileptic drug (AED) in seizure-naive newly-diagnosed glioma patients. Data regarding prophylactic AED use are scant and inconclusive from older, small studies that enrolled patients with brain metastases, benign tumours and gliomas. A definitive randomised controlled trial (RCT) is needed to determine whether the policy of prophylactic AED therapy reduces the risk of first seizures in this population.DesignMulti-centre RCT.SubjectsInclusion criteria: i. seizure-naive, ii. supratentorial glioma suitable for surgery (biopsy/resection), iii. age ≥16 years; iv. Karnofsky performance status >60.MethodsPatients are randomised 1:1. Levetiracetam 500 mg bd for 2 weeks, increased to 750 mg bd thereafter for 1 year. Non-blinded. No placebo. Primary Outcome: one year risk of first seizure. Secondary outcomes: time to first seizure, time to first tonic-clonic seizure, mood, fatigue, quality of life, progression free survival, overall survival and incremental cost per QALY. Estimate of 1 year seizure rate in glioma after surgery is 20%. Based on a reduction in seizure rate to 10% a total of 806 patients will be recruited.ResultsGrant awarded by NIHR. Feasibility questionnaire demonstrated prophylactic AED rarely used. Neurosurgeons willing to randomise. 15 UK centres have expressed interest in participating.ConclusionsSPRING will establish class I evidence for the use of seizure prophylaxis in glioma surgery. The trial will open to recruitment in January 2019.

Phase III Randomized Controlled Trial Comparing the Survival of Patients With Unresectable Hepatocellular Carcinoma Treated With Nolatrexed or Doxorubicin

2007 ◽  
Vol 25 (21) ◽  
pp. 3069-3075 ◽  
Author(s):  
Robert G. Gish ◽  
Camillo Porta ◽  
Lucian Lazar ◽  
Paul Ruff ◽  
Ronald Feld ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Karnofsky Performance Status ◽  
Controlled Trial ◽  
Performance Status ◽  
Objective Response ◽  
Progression Free Survival ◽  
Final Analysis ◽  
Complete Response ◽  
Phase Iii ◽  
Study Objective

PurposeThe study objective was to compare the overall survival (OS) of patients with unresectable or metastatic hepatocellular carcinoma (HCC) treated with nolatrexed (NOL) or doxorubicin (DOX).Patients and MethodsPatients from North America, Europe, and South Africa (N = 445) with HCC were randomly assigned to receive NOL or DOX. Eligible patients had Karnofsky performance status (KPS) ≥ 60%, Cancer of the Liver Italian Program (CLIP) score ≤ 3, and adequate organ function. Primary end point was OS. Secondary end points included progression-free survival (PFS), objective response rates, and safety. The treatment groups were well-balanced with regards to age, sex, ethnic origin, and underlying liver disease. Randomization was stratified according to KPS and CLIP score.ResultsAt the time of the final analysis, 377 patients had died. Median OS was 22.3 weeks for NOL and 32.3 weeks for DOX (P = .0068). The hazard ratio was 0.753 in favor of DOX. Objective response rate (complete response [CR] plus partial response [PR]) was 1.4% for NOL and 4.0% for DOX. Median PFS was 12 weeks for NOL and 10 weeks for DOX (P = .7091). Median time to treatment failure was 8.4 weeks for NOL and 9.1 weeks for DOX (P = .0969). Grade 3 and 4 stomatitis, vomiting, diarrhea, and thrombocytopenia were more common in the NOL arm. Alopecia was more common in the DOX arm. More patients were withdrawn from study for toxicity in the NOL arm than in the DOX arm.ConclusionNOL showed minimal activity in this phase III trial. Further exploration at this dose and schedule in HCC is not warranted.

High and Low Responders in a Comprehensive Lifestyle Program for Weight Loss - Secondary Analysis of a Randomized Controlled Trial

2017 ◽  
Vol 24 (4) ◽  
pp. 232-239 ◽  
Author(s):  
Dieter Melchart ◽  
Erich Wühr ◽  
Wolfgang Weidenhammer
Keyword(s):  
Weight Loss ◽  
Randomized Controlled Trial ◽  
Weight Reduction ◽  
Controlled Trial ◽  
Secondary Analysis ◽  
Overweight And Obesity ◽  
High Response ◽  
Self Monitoring ◽  
Randomized Controlled ◽  
Lifestyle Program

Background/Objectives: Unhealthy lifestyle is often related to overweight and obesity and thus to chronic diseases. Web-based programs might be an option for a comprehensive approach to improving long-term weight management. Data from a randomized controlled trial (RCT) evaluating the impact of a lifestyle program on weight reduction were used for a secondary analysis. The objectives were (a) to identify potential predictors for marked weight loss, (b) to explore associations of weight reduction with changes in health-related variables, and (c) to evaluate whether self-monitoring of the daily lifestyle is associated with weight loss. Methods: 67 subjects with a body mass index of 28-35 who underwent the 1-year ‘Individual Health Management' (IHM) program were included in the analysis (mean age 49.8 years, 79% female). Two subgroups (high response: ≥7.5% weight reduction vs. low response: <7.5%) were compared in terms of sociodemographic data, baseline values, and pre-post changes of various risk and protective factors. A logistic regression was performed to identify potential predictors of weight loss. Results: 70% of the subjects fulfilled the criterion of high response. There were no statistically significant differences between the two subgroups with respect to sociodemographic and baseline data. Regression analysis failed to identify any predictors for the amount of weight reduction. Subjects with high response showed a more distinct improvement in life satisfaction and neurovegetative stability. The findings indicated an association between the level of self-monitoring and weight loss. Conclusions: More research is needed to establish optimal strategies for maximizing the longer-term maintenance of weight loss and prevention effects. For weight reduction, support strategies like feedback learning through self-monitoring, reporting systems, and self-performance measurement with questionnaires might ameliorate high-intensity lifestyle modification programs.

scholarly journals Eating self-efficacy changes in individuals with type 2 diabetes following a structured lifestyle intervention based on the transcultural Diabetes Nutrition Algorithm (tDNA): A secondary analysis of a randomized controlled trial

PLoS ONE ◽  
2020 ◽  
Vol 15 (11) ◽  
pp. e0242487
Author(s):  
Harvinder Kaur Gilcharan Singh ◽  
Winnie Siew Swee Chee ◽  
Osama Hamdy ◽  
Jeffrey Ian Mechanick ◽  
Verna Kar Mun Lee ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Clinical Trial ◽  
Weight Loss ◽  
Motivational Interviewing ◽  
Lifestyle Intervention ◽  
Self Efficacy ◽  
Controlled Trial ◽  
Secondary Analysis ◽  
Registration Number

Objective Eating self-efficacy behavior is an important predictor of successful lifestyle intervention. This secondary analysis evaluated the changes in eating self-efficacy behavior in patients with type 2 diabetes (T2D) and overweight/obesity following structured lifestyle intervention based on the Malaysian customized transcultural Diabetes Nutrition Algorithm (tDNA). Methods Patients with T2D and overweight/obesity (n = 230) were randomized either into the tDNA group which included a structured low-calorie meal plan using normal foods, incorporation of diabetes-specific meal replacements, and an exercise prescription or usual T2D care (UC) for 6 months. Patients in the tDNA group also received either counseling with motivational interviewing (tDNA-MI) or conventional counseling (tDNA-CC). The UC group received standard dietary and exercise advice using conventional counseling. Eating self-efficacy was assessed using a locally validated Weight Efficacy Lifestyle (WEL) questionnaire. All patients were followed up for additional 6 months’ post-intervention. Results There was a significant change in WEL scores with intervention over one-year [Group X Time effect: F = 51.4, df = (3.4, 318.7), p<0.001]. Compared to baseline, WEL scores improved in both the tDNA groups with significantly higher improvement in the tDNA-MI group compared to the tDNA-CC and UC groups at 6 months (tDNA-MI: 25.4±2.1 vs. tDNA-CC: 12.9±2.8 vs. UC: -6.9±1.9, p<0.001). At 12 months’ follow-up, both the tDNA groups maintained improvement in the WEL scores, with significantly higher scores in the tDNA-MI group than tDNA-CC group, and the UC group had decreased WEL scores (tDNA-MI: 28.9±3.1 vs. tDNA-CC: 11.6±3.6 vs. UC: -13.2±2.1, p<0.001). Patients in the tDNA-MI group with greater weight loss and hemoglobin A1C reduction also had a higher eating self-efficacy, with a similar trend observed in comparative groups. Conclusion Eating self-efficacy improved in patients with T2D and overweight/obesity who maintained their weight loss and glycemic control following a structured lifestyle intervention based on the Malaysian customized tDNA and the improvement was further enhanced with motivational interviewing. Clinical trial This randomized clinical trial was registered under National Medical Research Registry, Ministry of Health Malaysia with registration number: NMRR-14-1042-19455 and also under ClinicalTrials.gov with registration number: NCT03881540.

Zoledronate Slows Weight Loss and Maintains Fat Mass in Osteopenic Older Women: Secondary Analysis of a Randomized Controlled Trial

2020 ◽  
Vol 106 (4) ◽  
pp. 386-391
Author(s):  
Ian R. Reid ◽  
Anne M. Horne ◽  
Borislav Mihov ◽  
Angela Stewart ◽  
Sonja Bastin ◽  
...  
Keyword(s):  
Weight Loss ◽  
Randomized Controlled Trial ◽  
Older Women ◽  
Fat Mass ◽  
Controlled Trial ◽  
Secondary Analysis ◽  
Randomized Controlled

Ultrafractionated radiation therapy (3x per day) for glioblastoma: Preliminary results of a phase II study

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 1570-1570
Author(s):  
P. D. Beauchesne ◽  
L. Taillandier ◽  
V. Bernier ◽  
M. Djabri ◽  
X. Michel ◽  
...  
Keyword(s):  
Radiation Therapy ◽  
Phase Ii ◽  
High Efficiency ◽  
Phase Ii Study ◽  
Karnofsky Performance Status ◽  
Performance Status ◽  
Progression Free Survival ◽  
Who Grade ◽  
Primary Endpoints ◽  
Grade 3

1570 Background: Ultrafractionation radiation therapy consists in irradiating cells or tumors several times daily, delivering low doses at which hyperradiosensitivity occur. We recently reported the high efficiency of ultrafractionation radiotherapy in glioma cell lines and xenografts, and are now conducting a phase II clinical trial to determine the effect of an ultrafractionation regimen for glioblastoma patients. Methods: A prospective, multicenter, phase II study has opened for accrual in September 2003. Patients over 18 years of age who are able to give informed consent and have histologically proven, newly diagnosed and unresectable, supratentorial glioblastoma (WHO grade IV) are eligible. Three doses of 0.75 Gy spaced by at least four hours are delivered daily, five days a week for six consecutive weeks for a total of 67.5 Gy. Conformal irradiation includes the tumor bulk including a margin of 2.5 cm. Tolerance and toxicity are the primary endpoints; survival and progression-free survival are secondary endpoints. Results: To date 25 patients have been enrolled in this study, 19 currently evalualbe: 11 men and 8 women, median age 58 (range 37 to 76), median Karnofsky performance status (80 range from 70 to 100). The median time between histological diagnosis and the start of treatment is 7 weeks. The ultrafractionated radiation therapy has been well tolerated; no acute grade 3 and/or 4 CNS toxicity has been observed. Minor responses at the end of irradiation were seen in 5 patients. Median survival from initial diagnosis was 13.5 months, nine patients remain alive. Conclusions: Ultrafractionated radiation therapy is safe and well tolerated. No acute CNS toxicitiy has been observed. Overall survival of over 13 months for patients without prior debulking surgery compares favorably with other reports. Updated definitive results will be presented. No significant financial relationships to disclose.

Sign in / Sign up

Export Citation Format

Share Document