Abstract GS02-10: Effects of a structured and individualized exercise program on fatigue and health-related quality of life in patients with metastatic breast cancer: the multinational randomized controlled PREFERABLE-EFFECT study
Artículo
Materias > Biomedicina
Materias > Educación física y el deporte
Universidad Europea del Atlántico > Investigación > Artículos y libros
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INTRODUCTION:
Patients with metastatic breast cancer (mBC) often experience cancer- and treatment-related side effects that can impair daily life activities and health-related quality of life (HRQoL). Interventions are needed that improve HRQoL by alleviating fatigue and other side effects during palliative BC cancer treatment. Recent evidence-based international guidelines (ASCO, ACSM) recommend exercise for patients with BC during adjuvant treatment for reducing side effects. However, evidence of the effectiveness of exercise in patients with mBC is scarce. The PREFERABLE-EFFECT study (NCT04120298) was designed to assess the effects of a 9-month supervised exercise program in patients with mBC on fatigue, HRQoL, and other cancer- and treatment-related side effects.
METHODS:
PREFERABLE-EFFECT is a multinational, randomized controlled trial including patients with mBC from five European countries (Germany, Poland, Spain, Sweden, The Netherlands) and Australia. Participants were randomly assigned to usual care or an individualized, structured exercise program consisting of aerobic, resistance, and balance training. The first six months included twice weekly supervised exercise sessions of one hour. In the last three months, one supervised session was replaced by an unsupervised session, supplemented by an exercise App. All participants received general exercise advice (physical activity ≥ 30 min/day) and an activity tracker. Our primary outcomes, physical fatigue (subscale of the EORTC QLQ-FA12) and HRQoL (summary score of the EORTC QLQ-C30), were assessed at baseline, 3, 6, and 9 months. Among other physical fitness outcomes, maximal short exercise capacity was assessed with the Steep Ramp Test. The intervention effects (intention-to-treat) were determined by comparing the change from baseline to 3, 6 (i.e., primary endpoint) and 9 months between groups using separate mixed models for repeated measures, adjusted for baseline values of the outcome variable and stratification factors (mBC line of treatment (1st/2nd vs. 3rd or higher) and study center). A significant improvement of either or both primary outcomes (applying the Bonferroni-Holm method) was considered as successful.
RESULTS:
Between 2019-2022, we included 357 patients with mBC, with 178 patients randomized to the exercise intervention and 179 to usual care. Patients were, on average, 55.4 years of age (SD=11.1), most patients received 1st or 2nd line of treatment at study enrollment (74.8%) and had bone metastases (73.9%). At 6 months (primary endpoint), participation in the exercise intervention resulted in statistically significant positive effects on both primary outcomes, compared to usual care: physical fatigue was lower (mean difference: -5.3, 95% CI -10.0; -0.6, p=0.027, effect size (ES)=0.22) and HRQoL was better (+4.8, 95% CI 2.2; 7.4, p=0.0003, ES=0.33). Beneficial effects were also found at 3 months (physical fatigue: -3.4, -7.8; 1.0, ES=0.14 and QoL: 3.9, 1.5; 6.3, ES=0.27) and 9 months (physical fatigue: -5.6, -10.9; -0.4, ES=0.24 and QoL: +4.3, 1.4; 7.3, ES=0.31). Further, at the primary endpoint, we found positive exercise effects on physical fitness (+24.3 Watts, 15.5; 33.1, ES=0.42) and numerous QLQ-C30 scales, including social functioning (+5.5, 0.2; 10.8, ES=0.20), pain (-7.1, -12.1; -1.9, ES=0.28) and dyspnea (-7.6, -12.2; -3.0, ES=0.28). Two SAEs occurred (one wrist fracture and one sacral stress fracture), neither related to bone metastases.
CONCLUSION:
This large multinational study demonstrated significant beneficial effects of a supervised exercise intervention offered during palliative treatment on mBC patients’ fatigue, HRQoL, and other clinically relevant outcomes. Based on these findings, we recommend supervised resistance and aerobic exercise as part of supportive care regimens during palliative treatment of mBC.
metadata
May, Anne; Hiensch, Anouk; Depenbusch, Johanna; Schmidt, Martina; Monninkhof, Evelyn; Peláez, Mireia; Clauss, Dorothea; Zimmer, Philipp; Belloso, Jon; Trevaskis, Mark; Rundqvist, Helene; Wiskemann, Joachim; Muller, Jana; Fremd, Carlo; Altena, Renske; Kufel-Grabowska, Joanna; Bijlsma, Rhode; van Leeuwen-Snoeks, Lobke; Bokkel-Huinink, Daan ten; Sonke, Gabe; Mann, Bruce; Francis, Prudence; Richardson, Gary; Álvarez, Isabel; Malter, Wolfram; Van der Wall, Elsken; Aaronson, Neil; Senkus, Elżbieta; Urriticoechea, Ander; Zopf, Eva; Bloch, Wilhelm; Stuiver, Martijn; Wengström, Yvonne y Steindorf, Karen
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SIN ESPECIFICAR, SIN ESPECIFICAR, SIN ESPECIFICAR, SIN ESPECIFICAR, SIN ESPECIFICAR, mireia.pelaez@uneatlantico.es, SIN ESPECIFICAR, SIN ESPECIFICAR, SIN ESPECIFICAR, SIN ESPECIFICAR, SIN ESPECIFICAR, SIN ESPECIFICAR, SIN ESPECIFICAR, SIN ESPECIFICAR, SIN ESPECIFICAR, SIN ESPECIFICAR, SIN ESPECIFICAR, SIN ESPECIFICAR, SIN ESPECIFICAR, SIN ESPECIFICAR, SIN ESPECIFICAR, SIN ESPECIFICAR, SIN ESPECIFICAR, SIN ESPECIFICAR, SIN ESPECIFICAR, SIN ESPECIFICAR, SIN ESPECIFICAR, SIN ESPECIFICAR, SIN ESPECIFICAR, SIN ESPECIFICAR, SIN ESPECIFICAR, SIN ESPECIFICAR, SIN ESPECIFICAR, SIN ESPECIFICAR
(2024)
Abstract GS02-10: Effects of a structured and individualized exercise program on fatigue and health-related quality of life in patients with metastatic breast cancer: the multinational randomized controlled PREFERABLE-EFFECT study.
Cancer Research, 84 (9_Supp).
GS02-10.
ISSN 1538-7445
Resumen
INTRODUCTION: Patients with metastatic breast cancer (mBC) often experience cancer- and treatment-related side effects that can impair daily life activities and health-related quality of life (HRQoL). Interventions are needed that improve HRQoL by alleviating fatigue and other side effects during palliative BC cancer treatment. Recent evidence-based international guidelines (ASCO, ACSM) recommend exercise for patients with BC during adjuvant treatment for reducing side effects. However, evidence of the effectiveness of exercise in patients with mBC is scarce. The PREFERABLE-EFFECT study (NCT04120298) was designed to assess the effects of a 9-month supervised exercise program in patients with mBC on fatigue, HRQoL, and other cancer- and treatment-related side effects. METHODS: PREFERABLE-EFFECT is a multinational, randomized controlled trial including patients with mBC from five European countries (Germany, Poland, Spain, Sweden, The Netherlands) and Australia. Participants were randomly assigned to usual care or an individualized, structured exercise program consisting of aerobic, resistance, and balance training. The first six months included twice weekly supervised exercise sessions of one hour. In the last three months, one supervised session was replaced by an unsupervised session, supplemented by an exercise App. All participants received general exercise advice (physical activity ≥ 30 min/day) and an activity tracker. Our primary outcomes, physical fatigue (subscale of the EORTC QLQ-FA12) and HRQoL (summary score of the EORTC QLQ-C30), were assessed at baseline, 3, 6, and 9 months. Among other physical fitness outcomes, maximal short exercise capacity was assessed with the Steep Ramp Test. The intervention effects (intention-to-treat) were determined by comparing the change from baseline to 3, 6 (i.e., primary endpoint) and 9 months between groups using separate mixed models for repeated measures, adjusted for baseline values of the outcome variable and stratification factors (mBC line of treatment (1st/2nd vs. 3rd or higher) and study center). A significant improvement of either or both primary outcomes (applying the Bonferroni-Holm method) was considered as successful. RESULTS: Between 2019-2022, we included 357 patients with mBC, with 178 patients randomized to the exercise intervention and 179 to usual care. Patients were, on average, 55.4 years of age (SD=11.1), most patients received 1st or 2nd line of treatment at study enrollment (74.8%) and had bone metastases (73.9%). At 6 months (primary endpoint), participation in the exercise intervention resulted in statistically significant positive effects on both primary outcomes, compared to usual care: physical fatigue was lower (mean difference: -5.3, 95% CI -10.0; -0.6, p=0.027, effect size (ES)=0.22) and HRQoL was better (+4.8, 95% CI 2.2; 7.4, p=0.0003, ES=0.33). Beneficial effects were also found at 3 months (physical fatigue: -3.4, -7.8; 1.0, ES=0.14 and QoL: 3.9, 1.5; 6.3, ES=0.27) and 9 months (physical fatigue: -5.6, -10.9; -0.4, ES=0.24 and QoL: +4.3, 1.4; 7.3, ES=0.31). Further, at the primary endpoint, we found positive exercise effects on physical fitness (+24.3 Watts, 15.5; 33.1, ES=0.42) and numerous QLQ-C30 scales, including social functioning (+5.5, 0.2; 10.8, ES=0.20), pain (-7.1, -12.1; -1.9, ES=0.28) and dyspnea (-7.6, -12.2; -3.0, ES=0.28). Two SAEs occurred (one wrist fracture and one sacral stress fracture), neither related to bone metastases. CONCLUSION: This large multinational study demonstrated significant beneficial effects of a supervised exercise intervention offered during palliative treatment on mBC patients’ fatigue, HRQoL, and other clinically relevant outcomes. Based on these findings, we recommend supervised resistance and aerobic exercise as part of supportive care regimens during palliative treatment of mBC.
| Tipo de Documento: | Artículo |
|---|---|
| Clasificación temática: | Materias > Biomedicina Materias > Educación física y el deporte |
| Divisiones: | Universidad Europea del Atlántico > Investigación > Artículos y libros |
| Depositado: | 18 Sep 2024 23:30 |
| Ultima Modificación: | 18 Sep 2024 23:30 |
| URI: | https://repositorio.uneatlantico.es/id/eprint/14247 |
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Introduction Cancer in older adults is often associated with functional limitations, geriatric syndromes, poor self-rated health, vulnerability, and frailty, and these conditions might worsen treatment-related side effects. Recent guidelines for patients with cancer during and after treatment have documented the beneficial effects of exercise to counteract certain side effects; however, little is known about the role of exercise during cancer treatment in older adults. Materials and Methods This is a multicentre randomised controlled trial in which 200 participants will be allocated to a control group or an intervention group (the sample size has been calculated to detect a clinical difference of 1 point in Short Physical Performance Battery (SPPB) score, assuming an α error of 0.05, a β error of 0.20, and a 10 % loss rate). Patients aged ≥70 years, diagnosed with any type of solid cancer and candidates for systemic treatment are eligible. Subjects in the intervention group are invited to participate in a 12-week supervised multicomponent exercise programme in addition to receiving usual care. Study assessments are conducted at baseline and three months. The primary outcome measure is physical function as assessed by the SPPB. Secondary outcome measures include comprehensive geriatric assessment scores (including social situation, basic and instrumental activities of daily living, cognitive function, depression, nutritional status, polypharmacy, geriatric syndromes, pain, and emotional distress), anthropometric characteristics, frailty status, physical fitness, physical activity, cognitive function, quality of life, fatigue, and nutritional status. Study assessments also include analysis of inflammatory, endocrine, and nutritional mediators in serum and plasma as potential frailty biomarkers at mRNA and protein levels and multiparametric flow cytometric analysis to measure immunosenescence markers on T and NK cells. Discussion This study seeks to extend our knowledge on exercise interventions during systemic anticancer treatment in patients over 70 years of age. Results from this research will guide the management of older adults during systemic treatment in hospitals seeking to enhance the standard of care.
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