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Feasibility, safety, and efficacy of aerobic training in pretreated patients with metastatic breast cancer: A randomized controlled trial
Author(s) -
Scott Jessica M.,
Iyengar Neil M.,
Nilsen Tormod S.,
Michalski Meghan,
Thomas Samantha M.,
Herndon James,
Sasso John,
Yu Anthony,
Chandarlapaty Sarat,
Dang Chau T.,
Comen Elizabeth A.,
Dickler Maura N.,
Peppercorn Jeffrey M.,
Jones Lee W.
Publication year - 2018
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/cncr.31368
Subject(s) - medicine , aerobic exercise , tolerability , breast cancer , clinical endpoint , vo2 max , physical therapy , aerobic capacity , randomized controlled trial , cancer , adverse effect , heart rate , blood pressure
BACKGROUND The investigation of exercise training in metastatic breast cancer has received minimal attention. This study determined the feasibility and safety of aerobic training in metastatic breast cancer. METHODS Sixty‐five women (age, 21‐80 years) with metastatic (stage IV) breast cancer (57% were receiving chemotherapy, and >40% had ≥ 2 lines of prior therapy) were allocated to an aerobic training group (n = 33) or a stretching group (n = 32). Aerobic training consisted of 36 supervised treadmill walking sessions delivered thrice weekly between 55% and 80% of peak oxygen consumption (VO 2peak ) for 12 consecutive weeks. Stretching was matched to aerobic training with respect to location, frequency, duration, and intervention length. The primary endpoint was aerobic training feasibility, which was a priori defined as the lost to follow‐up (LTF) rate (<20%) and attendance (≥70%). Secondary endpoints were safety, objective outcomes (VO 2peak and functional capacity), and patient‐reported outcomes (PROs; quality of life). RESULTS One of the 33 patients (3%) receiving aerobic training was LTF, whereas the mean attendance rate was 63% ± 30%. The rates of permanent discontinuation and dose modification were 27% and 49%, respectively. Intention‐to‐treat analyses indicated improvements in PROs, which favored the attention control group ( P values > .05). Per protocol analyses indicated that 14 of 33 patients (42%) receiving aerobic training had acceptable tolerability (relative dose intensity ≥ 70%), and this led to improvements in VO 2peak and functional capacity ( P values < .05). CONCLUSIONS Aerobic training at the dose and schedule tested is safe but not feasible for a significant proportion of patients with metastatic breast cancer. The acceptable feasibility and promising benefit for select patients warrant further evaluation in a dose‐finding phase 1/2 study. Cancer 2018;124:2552‐60. © 2018 American Cancer Society .