Dataset Information

Exercise volume load in women with breast cancer: Study protocol for the ABRACE randomized clinical trial.

ABSTRACT:

Background

An increased number of breast cancer patients are challenged by acute and persistent treatment side effects. Oncology guidelines have been establishing physical exercise to counteract several treatment-related toxicities throughout cancer care. However, evidence regarding the optimal dose-response, feasibility, and the minimal resistance exercise volume and/or intensity remains unclear. The ABRACE Study will assess the impact of different resistance training volumes (i.e., single or multiple sets) combined with aerobic exercise on physical and psychological outcomes of breast cancer patients undergoing primary treatment.

Methods

This study is a randomized, controlled, three-armed parallel trial. A total of 84 participants, aged ≥18 years, with breast cancer stages I-III, initiating adjuvant or neoadjuvant chemotherapy (≤50% of sessions completed) will be randomized to multiple sets resistance training plus aerobic training group, single set resistance training plus aerobic training group or control group. Neuromuscular and cancer-related fatigue (primary outcomes), muscle strength, muscle thickness, muscle quality by echo intensity, body composition, cardiorespiratory capacity, functional performance, upper-body endurance and quality of life will be measured before and after the 12-week intervention. Our analysis will follow the intention-to-treat approach and per-protocol criteria, with additional sub-group analysis.

Discussion

Findings support prescribing exercise during chemotherapy for breast cancer and elucidate the potential role of different resistance training volumes as a management strategy for physical and psychological impairments in women with early-stage breast cancer. Our main hypothesis is for superiority in physical and psychological outcomes for both training groups compared to the control group, with no difference between single or multiple sets groups.

Trial registration

Clinical trials NCT03314168.

SUBMITTER: Henkin JS

PROVIDER: S-EPMC9798137 | biostudies-literature | 2023 Feb

REPOSITORIES: biostudies-literature

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Publications

Exercise volume load in women with breast cancer: Study protocol for the ABRACE randomized clinical trial.

Henkin João Saldanha JS Rosa Daniela Dornelles DD Morelle Alessandra Menezes AM Caleffi Maira M Pinto Stephanie Santanna SS Pinto Ronei Silveira RS

Contemporary clinical trials communications 20221220

<h4>Background</h4>An increased number of breast cancer patients are challenged by acute and persistent treatment side effects. Oncology guidelines have been establishing physical exercise to counteract several treatment-related toxicities throughout cancer care. However, evidence regarding the optimal dose-response, feasibility, and the minimal resistance exercise volume and/or intensity remains unclear. The ABRACE Study will assess the impact of different resistance training volumes (i.e., sin ...[more]

PMID: 36589863

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Project description:BackgroundPeer-based exercise interventions that cultivate new opportunities for support with a fellow cancer survivor may result in increased exercise volume. It is not clear whether adding qualified exercise professional (QEP) support to peer-based interventions improves health outcomes. Therefore, the purpose of this study is to determine whether breast cancer survivor (BCS) dyads who receive 10 weekly sessions of virtually delivered QEP support have improved outcomes compared to BCS dyads who do not receive QEP support.MethodsParticipants Adult BCS with medical clearance for exercise, who have an internet-connected device, and currently engage in < 150 min of moderate-intensity exercise per week. Intervention BCS will be matched using evidence-based criteria. The intervention group will receive dyadic exercise information sessions and a program tailored by a QEP for 10 weeks (intervention period) and have access to the QEP for an additional 4 weeks (tapering period). The control will not receive any QEP support. Outcomes The primary outcome is post-intervention self-reported exercise volume. Secondary outcomes include device-assessed exercise volume (i.e., Fitbit), social support, and health-related quality of life. Randomization 108 participants, matched in dyads, will be randomized 1:1 to the MatchQEP or Match groups using a web-based scheme. Statistical analysis Outcomes will be measured at baseline, post-intervention, post-tapering, and at 12 weeks post-intervention follow-up.DiscussionThe findings from this RCT will determine if matched BCS dyads who receive 10 weeks of virtually delivered QEP support have higher levels of self-report and device-measured exercise, social support, and health related quality of life compared to matched dyads without QEP-delivered exercise guidance. To our knowledge this will be the first study to assess the combined effect of peer- and QEP support on exercise volume. Project findings will inform and optimize intervention methods aimed to increase exercise among BCS through accessible exercise supports.Trial registrationThe study is registered on ClinicalTrials.gov (study identifier: NCT04771975, protocol Version Number: 2, date: July 22, 2021).

Project description:BackgroundUp to 75% of women diagnosed with breast cancer report chemotherapy-related cognitive changes (CRCC) during treatment, including decreased memory, attention, and processing speed. Though CRCC negatively impacts everyday functioning and reduces overall quality of life in women diagnosed with breast cancer, effective interventions to prevent and/or manage CRCC are elusive. Consequently, women seldom receive advice on how to prevent or manage CRCC. Aerobic exercise is associated with improved cognitive functioning in healthy older adults and adults with cognitive impairments. Accordingly, it holds promise as an intervention to prevent and/or manage CRCC. However, evidence from randomized controlled trials (RCTs) supporting a beneficial effect of aerobic exercise on CRCC is limited. The primary aim of the ACTIVATE trial is to evaluate the impact of supervised aerobic exercise on CRCC in women receiving chemotherapy for breast cancer.MethodsThe ACTIVATE trial is a two-arm, two-centre RCT. Women diagnosed with stage I-III breast cancer and awaiting neo-adjuvant or adjuvant chemotherapy are recruited from hospitals in Ottawa (Ontario) and Vancouver (British Columbia), Canada. Recruits are randomized to the intervention group (aerobic exercise during chemotherapy) or the wait-list control group (usual care during chemotherapy and aerobic exercise post-chemotherapy). The primary outcome is cognitive functioning as measured by a composite cognitive summary score (COGSUM) of several neuropsychological tests. Secondary outcomes are self-reported cognitive functioning, quality of life, and brain structure and functioning (measured by magnetic resonance imaging (MRI)/functional MRI and electroencephalography). Assessments take place pre-chemotherapy (pre-intervention), mid-way through chemotherapy (mid-intervention/mid-wait period), end of chemotherapy (post-intervention/post-wait period; primary endpoint), 16-weeks post-chemotherapy, and at 1-year post-baseline.DiscussionAerobic exercise is a promising intervention for preventing and/or managing CRCC and enhancing quality of life among women diagnosed with breast cancer. The ACTIVATE trial tests several novel hypotheses, including that aerobic exercise can prevent and/or mitigate CRCC and that this effect is mediated by the timing of intervention delivery (i.e., during versus post-chemotherapy). Findings may support prescribing exercise during (or post-) chemotherapy for breast cancer and elucidate the potential role of aerobic exercise as a management strategy for CRCC in women with early-stage breast cancer.Trial registrationThe trial was registered with the ClinicalTrials.gov database ( NCT03277898 ) on September 11, 2017.

Project description:BackgroundAs the prevalence of chemotherapy-related cognitive impairment rises, investigation into treatment options is critical. The objectives of this study were to test the effects of an aerobic exercise intervention initiated during chemotherapy compared to usual care (wait list control condition) on (1) objectively measured cognitive function and self-reported cognitive function, as well as on (2) the impact of cognitive impairment on quality of life (QOL) postintervention (commensurate with chemotherapy completion).MethodsThe Aerobic exercise and CogniTIVe functioning in women with breAsT cancEr (ACTIVATE) trial was a two-arm, two-center randomized controlled trial conducted in Ottawa and Vancouver (Canada). Fifty-seven women (Mage, 48.8 ± 10 years) diagnosed with stage I-III breast cancer and awaiting chemotherapy were randomized to aerobic exercise initiated with chemotherapy (nEX = 28) or usual care during chemotherapy with aerobic exercise after chemotherapy completion (nUC = 29). The intervention lasted 12-24 weeks and consisted of supervised aerobic training and at-home exercise. The primary outcome was objective cognitive function measured via 13 neuropsychological tests (standardized to M ± SD, 0 ± 1); secondary outcomes of self-reported cognitive function and its impact on QOL were assessed via questionnaires. Data collected pre- and postintervention (the primary end point) were analyzed.ResultsAlthough no significant differences between groups were found for objective cognitive function outcomes postintervention after accounting for multiple testing, four of six self-reported cognitive function outcomes showed significant differences favoring the aerobic exercise group.ConclusionsAmong women initiating chemotherapy for breast cancer, aerobic exercise did not result in significant differences in objective cognitive function postintervention after chemotherapy completion; however, the results do support the use of this intervention for improving self-reported cognitive function and its impact on QOL.

Project description:BackgroundExercise is associated with improved survival, physical functioning, treatment tolerability, and quality of life in early-stage breast cancer. These same endpoints matter in metastatic breast cancer (MBC). Prior trials in MBC have found exercise to be not feasible or of limited benefit, possibly due to inclusion of patients with heterogeneous disease trajectories. Patients with MBC have variable disease trajectories and supportive care needs; those with indolent MBC have longer life expectancy, lower symptom burden and distinct priorities, and are well-positioned to participate in and benefit from an exercise program. The EMBody trial aims to determine the impact of a multimodal exercise intervention on cardiorespiratory fitness, physical function, body composition, and patient-reported outcomes, specifically in patients with stable, indolent MBC.MethodsEligible patients have MBC with no evidence of disease progression on current therapy in the prior 12 months and cannot be receiving cytotoxic chemotherapy. The trial aims to enroll 100 patients, randomized 1:1 to the exercise intervention versus usual care, stratified by baseline function. The virtually-delivered exercise intervention arm achieves moderate intensity exercise with exercise physiologists 3 days/week for 16 weeks. The 60-minute sessions include aerobic, resistance, balance and stretching exercises. The exercise arm receives informational sessions on the role of exercise in cancer and principles of habit and self-efficacy. The primary endpoint is 16 week change in fitness on a ramp treadmill test between the exercise and control arms. Secondary endpoints include change in a physical function, muscle mass assessed by CT scans, and PROs of fatigue and quality of life. Exploratory analysis includes behavioral modifiers of exercise adherence and effectiveness and serologic measures of inflammatory, metabolic, and immune pathway biomarkers.DiscussionThe EMBody trial evaluates exercise in a unique patient population with indolent, non-progressive MBC. Patients living with MBC experience similar symptom burden to those undergoing therapy for early-stage disease and the benefits achieved with exercise could be similarly impactful. This trial will contribute evidence to support expansion of exercise recommendations, among other survivorship care efforts, to those living with metastatic disease.Clinical trial informationNCT05468034.Trial registrationNCT05468034. Date of registration: 7/12/2022.

Project description:ImportanceThe Framingham Risk Score (FRS) is a valid method for predicting the 10-year risk of developing cardiovascular disease. Higher FRS is reported in patients with early-stage breast cancer who are overweight than in healthy, age-matched women, but whether exercise reduces FRS in this patient population is unclear.ObjectiveTo examine the effects of a 16-week aerobic and resistance exercise intervention on the FRS in women with early-stage breast cancer and with overweight condition or obesity.Design, setting, and participantsThis single-center, prospective randomized clinical trial included 100 women with stage I to III breast cancer who were sedentary, with overweight condition or obesity (body mass index of ≥25.0 or body fat of ≥30%), and completed cancer treatment within 6 months prior to enrollment. Participants were randomized to either the usual care or exercise group. Differences in mean changes for outcomes were evaluated using mixed-model repeated-measures analyses. Data were collected from August 1, 2012, through July 1, 2017. Data analysis, which followed the intention-to-treat approach, was performed from May 24 to October 2, 2018.InterventionsThe exercise group underwent supervised aerobic and resistance exercise sessions thrice weekly for 16 weeks.Main outcomes and measuresThe FRS was calculated for each participant using preset points for each of the 6 FRS categories: age, systolic blood pressure, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, diabetes presence, and smoking status.ResultsIn total, 100 women were randomized to either the exercise group (n = 50) or usual care group (n = 50). Of these women, 55 (55%) were of Hispanic white race/ethnicity and the mean (SD) age was 53.5 (10.4) years. The mean (SD) total FRS scores postintervention were 2.0 (1.5) in the exercise group and 13.0 (3.0) in the usual care group. The postintervention FRS was significantly reduced in the exercise group compared with the usual care group (mean, -9.5; 95% CI, -13.0 to -6.0), which corresponds to an 11% (95% CI, -15.0 to -5.0) decrease on the FRS-predicted 10-year risk of developing cardiovascular disease.Conclusions and relevanceA 16-week supervised aerobic and resistance exercise intervention appeared to reduce the FRS-predicted 10-year risk of cardiovascular disease in women with early-stage breast cancer with overweight condition or obesity.Clinical trial registrationClinicalTrials.gov identifier: NCT01140282.

Dataset Information

Exercise volume load in women with breast cancer: Study protocol for the ABRACE randomized clinical trial.

Background

Methods

Discussion

Trial registration

Publications

Exercise volume load in women with breast cancer: Study protocol for the ABRACE randomized clinical trial.

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