Design of the Physical exercise during Adjuvant Chemotherapy Effectiveness Study (PACES):A randomized controlled trial to evaluate effectiveness and cost-effectiveness of physical exercise in improving physical fitness and reducing fatigue

<p>Abstract</p> <p>Background</p> <p>Cancer chemotherapy is frequently associated with a decline in general physical condition, exercise tolerance, and muscle strength and with an increase in fatigue. While accumulating evidence suggests that physical activity and exercise interventions during chemotherapy treatment may contribute to maintaining cardiorespiratory fitness and strength, the results of studies conducted to date have not been consistent. Additional research is needed to determine the optimal intensity of exercise training programs in general and in particular the relative effectiveness of supervised, outpatient (hospital- or physical therapy practice-based) versus home-based programs.</p> <p>Methods</p> <p>This multicenter, prospective, randomized trial will evaluate the effectiveness of a low to moderate intensity, home-based, self-management physical activity program, and a high intensity, structured, supervised exercise program, in maintaining or enhancing physical fitness (cardiorespiratory fitness and muscle strength), in minimizing fatigue and in enhancing the health-related quality of life (HRQoL). Patients receiving adjuvant chemotherapy for breast or colon cancer (n = 360) are being recruited from twelve hospitals in the Netherlands, and randomly allocated to one of the two treatment groups or to a 'usual care' control group. Performance-based and self-reported outcomes are assessed at baseline, at the end of chemotherapy and at six month follow-up.</p> <p>Discussion</p> <p>This large, multicenter, randomized clinical trial will provide additional empirical evidence regarding the effectiveness of physical exercise during adjuvant chemotherapy in enhancing physical fitness, minimizing fatigue, and maintaining or enhancing patients' quality of life. If demonstrated to be effective, exercise intervention programs will be a welcome addition to the standard program of care offered to patients with cancer receiving chemotherapy.</p> <p>Trial registration</p> <p>This study is registered at the Netherlands Trial Register (NTR 2159)</p

Angiotensin-converting enzyme gene polymorphism (ACEGP) and cancer cachexia (CC): Is there a link?

9011 Background: ACEGP greatly influences functional status and is currently the gene most involved in human fitness. The insertion allele (II) (a 287 bp fragment) rather than the deletion allele (DD) for the angiotensin-converting enzyme (ACE) gene is associated with low ACE levels in tissues and enhanced metabolic efficiency, as demonstrated by an improved response to vigorous training in healthy individuals. In addition, lower tissue ACE activity in mice was associated with decreased insulin resistance, greater glucose uptake in the skeletal muscle, and higher glycogen and fat stores. The aim of the study was to gather preliminary data on the potential association between muscle mass and ACEGP in advanced cancer patients (ACP). Methods: Buffy coat serum and plasma was obtained from 55 patients 18 years or older, newly diagnosed with Stage III (inoperable)-IV non-small cell lung cancer and unresectable/ metastatic gastrointestinal cancers seen within the McGill University Health Center. Muscle surface area (MSA-cm2) was calculated from computerized tomography slices at the L3 vertebrae using TOMOVISION SliceOmatic software version 4.3. Muscularity (M-cm2/m2) and lean body mass (LBM-kg) were calculated by extrapolation of image analysis used to quantify lean tissue. Results: ANOVA confirmed significant difference (p&lt;0.001) among MSA (II: 134.04±35.23; ID: 122.37±29.74; DD: 115.22±27.55), M (47.72±8.67; 41.65±9.26; 41.80±9.26), and LBM (43.00±11.21; 39.29±9.46; 37.01±8.77). In a multiple linear regression model, the II allele was associated with higher M (p=0.042) and a trend for higher MSA and LBM (p=0.059) independent of age, gender, diagnosis, and treatment received. Conclusions: Our data suggest ACEGP influences muscle mass in ACP. Further investigations in a larger sample of ACP are underway to determine whether ACEGP is an important predisposing factor to CC-associated muscle wasting. No significant financial relationships to disclose. </jats:p

Use of the scored Patient-Generated Subjective Global Assessment (PG-SGA) to characterize cachexia in newly diagnosed advanced cancer patients

9574 Background: Our objective was to evaluate whether the scored PGSGA questionnaire in advanced cancer patients (ACP) might relate better then weight loss (WL) alone to the nutritional, functional, biological and quality of life features of cachexia (C) and to some complications related to this syndrome. Methods: 214 newly diagnosed ACP with non-small cell lung and gastrointestinal primaries were categorized according to PG-SGA triage intervals of 0–1, 2–8 and ≥9 and also according to WL ≤5% or &gt;5%. Baseline assessments included: hand-grip strenght, body composition by DXA, selective measures of symptom and quality of life (QoL), CBC and differential counts, albumin and CRP. Survival hospitalization rates and data on chemotherapy tolerability were recorded during patient follow-up. Beta coefficients (β), odds ratios (OR), and hazard ratios (HR) were estimated to compare patients with &gt;5% WL to those with ≤5% WL and to compare patients with PGSGA of 0–1 to those with 2–8 and ≥9 scores. All analyses were controlled for gender, age, diagnosis (lung/GI), treatment (radio/chemo), survival (at 8 weeks), and medications. Results: PGSGA was better than the simple recording of WL in defining a population of patients that differed for WBC 109/L(&gt;5% WL β: 0.25 vs. 2–8 PGSGA β: 0.57 and ≥9 PGSGA β: 1.72), CRP mg/L (4.12 vs. 2.16 and 17.49), albumin g/L(-0.63 vs -2.60 and -4.45); weakness 0–10 (1.57 vs.1.56 and 3.32), anorexia 0–10 (2.36 vs. 2.36 and 5.17); Brief Fatigue Inventory 0–90 (17.75 vs. 9.89 and 25.15); McGill QoL 10–0 (-0.95 vs. -0.64 and -2.29); grip strength lbs.(-4.04 vs. -8.82 and -8.06); body fat kg. ( -8.74 vs. -5.94 and -11.72). PGSGA was able to better identify patients with higher rates of both hospitalization (2.6 vs. 1.62 and 9.46) and dose reduction of chemotherapy (1.2 vs. 0.58 and 1.74). Finally, PGSGA was able to better characterize patient survival as compared to WL alone (&gt;5% WL HR: 1.85; 2–8 PGSGA HR: 1.6 and ≥9 PGSGA HR 3.35). Conversely, WL alone was associated with higher probability of a sarcopenia diagnosis by DXA (&gt;5% WL OR: 1.56)Conclusions: Our data support the use of the PGSGA versus the simple recording of WL for identifying C, monitoring its clinical course and predicting possible complications of this syndrome in ACP. No significant financial relationships to disclose. </jats:p