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POSITIVE study: physical exercise program in non-operable lung cancer patients undergoing palliative treatment.

ABSTRACT: Patients with advanced stage non-small cell lung cancer (NSCLC) or small cell lung cancer (SCLC) often experience multidimensional impairments, affecting quality of life during their course of disease. In lung cancer patients with operable disease, several studies have shown that exercise has a positive impact on quality of life and physical functioning. There is limited evidence regarding efficacy for advanced lung cancer patients undergoing palliative treatment. Therefore, the POSITIVE study aims to evaluate the benefit of a 24-week exercise intervention during palliative treatment in a randomized controlled setting.The POSITIVE study is a randomized, controlled trial investigating the effects of a 24-week exercise intervention during palliative treatment on quality of life, physical performance and immune function in advanced, non-operable lung cancer patients. 250 patients will be recruited in the Clinic for Thoracic Diseases in Heidelberg, enrolment begun in November 2013. Main inclusion criterion is histologically confirmed NSCLC (stage IIIa, IIIb, IV) or SCLC (Limited Disease-SCLC, Extensive Disease-SCLC) not amenable to surgery. Patients are randomized into two groups. Both groups receive weekly care management phone calls (CMPCs) with the goal to assess symptoms and side effects. Additionally, one group receives a combined resistance and endurance training (3x/week). Primary endpoints are quality of life assessed by the Functional Assessment of Cancer Therapy for patients with lung cancer (FACT-L, subcategory Physical Well-Being) and General Fatigue measured by the Multidimensional Fatigue Inventory (MFI-20). Secondary endpoints are physical performance (maximal voluntary isometric contraction, 6-min walk distance), psychosocial (depression and anxiety) and immunological parameters and overall survival.The aim of the POSITIVE trial is the evaluation of effects of a 24-week structured and guided exercise intervention during palliative treatment stages. Analysis of various outcomes (such as quality of life, physical performance, self-efficacy, psychosocial and immunological parameters) will contribute to a better understanding of the potential of exercise in advanced lung cancer patients. In contrast to other studies with advanced oncological patients the POSITIVE trial provides weekly phone calls to support patients both in the intervention and control group and to segregate the impact of physical activity on quality of life.ClinicalTrials.gov NCT02055508 (Date: December 12, 2013).

SUBMITTER: Wiskemann J

PROVIDER: S-EPMC4949758 | biostudies-literature | 2016 Jul

REPOSITORIES: biostudies-literature

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POSITIVE study: physical exercise program in non-operable lung cancer patients undergoing palliative treatment.

Wiskemann Joachim J Hummler Simone S Diepold Christina C Keil Melanie M Abel Ulrich U Steindorf Karen K Beckhove Philipp P Ulrich Cornelia M CM Steins Martin M Thomas Michael M

BMC cancer 20160719

<h4>Background</h4>Patients with advanced stage non-small cell lung cancer (NSCLC) or small cell lung cancer (SCLC) often experience multidimensional impairments, affecting quality of life during their course of disease. In lung cancer patients with operable disease, several studies have shown that exercise has a positive impact on quality of life and physical functioning. There is limited evidence regarding efficacy for advanced lung cancer patients undergoing palliative treatment. Therefore, t ...[more]

PMID: 27430336

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Project description:BackgroundChronic venous insufficiency (CVI) is a common disease that causes discomfort and impairs the quality of life of affected persons. Treatments such as physical exercise that aim to increase the movement of the ankle joint and strengthen the muscle pump in the calf of the leg may be useful to reduce the symptoms of CVI.ObjectivesTo assess and summarise the existing clinical evidence on the efficacy and safety of physical exercise programmes for the treatment of individuals with non-ulcerated CVI.Search methodsThe Cochrane Vascular Information Specialist (CIS) searched the Cochrane Vascular Specialised Register (May 2016). In addition, the CIS searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2016, Issue 4) and trial databases for details of ongoing or unpublished studies.Selection criteriaRandomised controlled trials (RCTs) comparing exercise with no exercise programmes.Data collection and analysisTwo review authors independently assessed the search results and selected eligible studies. We resolved disagreements by discussion. We summarised and double-checked details from included studies. We attempted to contact trial authors for missing data, but obtained no further information.Main resultsWe included two trials involving 54 participants with CVI. Many of our review outcomes were not reported or reported by only one of the two studies. The intensity of disease signs and symptoms was measured in both studies but using different scales; we were therefore unable to pool the data. One study reported no difference between the exercise and control groups whereas the second reported a reduction in symptoms in the exercise group. In one study, increases in change in ejection fraction compared with baseline (mean difference (MD) 4.88%, 95% confidence interval (CI) 3.16 to 6.60; 30 participants; P < 0.00001), half venous refilling time (MD 4.20 seconds, 95% CI 3.28 to 5.12; 23 participants; P < 0.00001) and total venous refilling time (MD 9.40 seconds, 95% CI 7.77 to 11.03; 23 participants; P < 0.00001) were observed in the exercise group compared with the control group. One study reported no difference between the exercise and control groups with regard to quality of life or ankle range of motion. Although muscle strength assessed by dynamometry at slow speed did not differ between the two groups in this study, variable peak torque at fast speed was lower in the control group than in the exercise group (2.8 ± 0.9 compared with -0.3 ± 0.6, P < 0.03). The incidence of venous leg ulcers, incidence of surgical intervention to treat symptoms related to CVI and exercise capacity were not assessed or reported in either of the included trials. We rated both included studies as at high risk of bias; hence, these data should be interpreted carefully. Due to the small number of studies and small sample size, we were not able to verify indirectness and publication bias. Therefore, we judged the overall quality of evidence as very low according to the GRADE approach.Authors' conclusionsThere is currently insufficient evidence available to assess the efficacy of physical exercise in people with CVI. Future research into the effect of physical exercise should consider types of exercise protocols (intensity, frequency and time), sample size, blinding and homogeneity according to the severity of disease.

Project description:Radiation therapy effectively kills cancer cells and elicits local effects in the irradiated tissue. The aim of this study was to investigate the kinetics of cytokines in the serum of patients with lung cancer undergoing radiation therapy and to identify associations with metabolic tumor burden as determined by 2-deoxy-2-fluoro-D-glucose (18F-FDG) positron emission tomography (PET).Forty-five patients with advanced non-small cell lung cancer were included in a phase 2 clinical trial and randomized between fractionated thoracic radiation therapy alone or concurrent with an epidermal growth factor receptor inhibitor. Blood was sampled at 4 different time points: prior to treatment, midtherapy, at the end of therapy, and 6 to 8 weeks after the start of treatment. The serum concentrations of 48 cytokines and 9 matrix metalloproteinases were measured with multiplex immunoassays. A subset of patients was examined by 18F-FDG PET/computed tomography before, during, and after radiation therapy. The maximum standardized uptake values (SUVmax) of the primary lung tumor, whole-body metabolic tumor volume, and total lesion glycolysis were calculated, and correlations between the PET parameters and cytokines were investigated.The SUVmax decreased from baseline through midtherapy to posttherapy 18F-FDG PET/computed tomography (P?=?.018). The serum levels of C-C motif chemokine ligand (CCL) 23, CCL24, C-X3-C motif chemokine ligand 1, and interleukin-8 (C-X-C motif ligand [CXCL]8) were significantly correlated to SUVmax, metabolic tumor volume, and total lesion glycolysis before, during, and after radiation therapy. CXCL2 (P?=?.030) and CXCL6 (P?=?.010) decreased after the start of therapy and changed significantly across the sample time points. Serum concentrations of CCL15 (P?=?.031), CXCL2 (P?=?.028), and interleukin-6 (P?=?.007) were positively correlated to the irradiated volume during the second week of treatment.Cytokine serum levels vary and correlate with metabolic tumor burden in patients with advanced non-small cell lung cancer undergoing palliative thoracic radiation therapy.

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POSITIVE study: physical exercise program in non-operable lung cancer patients undergoing palliative treatment.

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POSITIVE study: physical exercise program in non-operable lung cancer patients undergoing palliative treatment.

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