Optitrain: a randomised controlled exercise trial for women with breast cancer undergoing chemotherapy.
BACKGROUND
Women with breast cancer undergoing chemotherapy suffer from a range of detrimental disease and treatment related side-effects. Exercise has shown to be able to counter some of these side-effects and improve physical function as well as quality of life. The primary aim of the study is to investigate and compare the effects of two different exercise regimens on the primary outcome cancer-related fatigue and the secondary outcomes muscle strength, function and structure, cardiovascular fitness, systemic inflammation, skeletal muscle gene activity, health related quality of life, pain, disease and treatment-related symptoms in women with breast cancer receiving chemotherapy. The second aim is to examine if any effects are sustained 1, 2, and 5 years following the completion of the intervention and to monitor return to work, recurrence and survival. The third aim of the study is to examine the effect of attendance and adherence rates on the effects of the exercise programme.


METHODS
This study is a randomised controlled trial including 240 women with breast cancer receiving chemotherapy in Stockholm, Sweden. The participants are randomly allocated to either: group 1: Aerobic training, group 2: Combined resistance and aerobic training, or group 3: usual care (control group). During the 5-year follow-up period, participants in the exercise groups will receive a physical activity prescription. Measurements for endpoints will take place at baseline, after 16 weeks (end of intervention) as well as after 1, 2 and 5 years.


CONCLUSIONS
This randomised controlled trial will generate substantial information regarding the effects of different types of exercise on the health of patients with breast cancer undergoing chemotherapy. We expect that dissemination of the knowledge gained from this study will contribute to developing effective long term strategies to improve the physical and psychosocial health of breast cancer survivors.


BACKGROUND
OptiTrain - Optimal Training Women with Breast Cancer (OptiTrain), NCT02522260 ; Registration: June 9, 2015, Last updated version Feb 29, 2016. Retrospectively registered.
Department of Neurobiology, Care Science and Society, Division of Nursing, Karolinska Institutet, Karolinska University Hospital, 141 83 Huddinge, Stockholm, Sweden. yvonne.wengstrom@ki.se.|Department of Oncology, Karolinska University Hospital, Stockholm, Sweden. yvonne.wengstrom@ki.se.
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Y
Wengström
Åstrand Laboratory of Work Physiology, The Swedish School of Sport and Health Sciences, Stockholm, Sweden.|School of Human Movement and Nutrition Sciences, The University of Queensland, Brisbane, Australia.
K A
KA
Bolam
Department of Physiology and Pharmacology, Karolinska Institutet, Stockholm, Sweden.
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S
Mijwel
Department of Physiology and Pharmacology, Karolinska Institutet, Stockholm, Sweden.|Unit for Bioentrepreneurship, Karolinska Institutet, Solna, Sweden.
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CJ
Sundberg
Department of Neurobiology, Care Science and Society, Division of Nursing, Karolinska Institutet, Karolinska University Hospital, 141 83 Huddinge, Stockholm, Sweden.|Department of Oncology, Karolinska University Hospital, Stockholm, Sweden.
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M
Backman
School of Health and Education, University of Skövde, Skövde, Sweden.
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M
Browall
Department of Physiology and Pharmacology, Karolinska Institutet, Stockholm, Sweden.
J
J
Norrbom
Department of Cell and Molecular Biology, Karolinska Institutet, Stockholm, Sweden.
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H
Rundqvist
D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use; D001943:Breast Neoplasms / Q000188:drug therapy / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D002319:Cardiovascular System / Q000503:physiopathology; D005081:Exercise Therapy; D005260:Female; D006801:Humans; D008875:Middle Aged; D053580:Muscle Strength; D018482:Muscle, Skeletal / Q000503:physiopathology; D013548:Sweden; D016896:Treatment Outcome; D055815:Young Adult
D000970:Antineoplastic Agents
Chemotherapy; Exercise intervention; Fatigue; Inflammation; Patients with breast cancer; Skeletal muscle