title: Safety and efficacy of aerobic training in operable breast cancer patients receiving neoadjuvant chemotherapy: a phase II randomized trial.
abstract: BACKGROUND
  To evaluate the safety and efficacy of moderate-to-high intensity aerobic training in breast cancer patients receiving neoadjuvant chemotherapy.
  
  
  METHODS
  Twenty patients with stage IIB-IIIC operable breast cancer were randomly assigned to receive doxorubicin plus cyclophosphamide (AC) or AC in combination with aerobic training (AC + AET) (n = 10/group) for 12 weeks. The AC+ AET group performed three supervised aerobic cycle ergometry sessions per week at 60%-100% of exercise capacity (VO2peak). Safety outcomes included exercise testing as well as treatment- and exercise training-related adverse events (AEs), whereas efficacy outcomes included cardiopulmonary function and patient-reported outcomes (PROs) as measured by a cardiopulmonary exercise test (CPET) and Functional Assessment of Cancer Therapy-Breast (FACT-B) scale.
  
  
  RESULTS
  Twelve non-significant ECG abnormalities and three non-life threatening events occurred during CPET procedures. One AE was reported during aerobic training. There were no significant between group differences for clinician-documented events (e.g. pain, nausea) or hematological parameters (p's > 0.05). Attendance and adherence rates to aerobic training were 82% and 66%, respectively. Intention-to-treat analysis indicated that VO2peak increased by 2.6 ± 3.5 ml/kg/min (+ 13.3%) in the AC + AET group and decreased by 1.5 ± 2.2 ml/kg/min (-8.6%) in the AC group (between group difference, p = 0.001). FACT-B increased 11.1 points in the AC + AET group compared to a 1.5 point decrease in the AC group (between group difference, p = 0.685).
  
  
  CONCLUSIONS
  Moderate-to-high intensity aerobic training when conducted with one-on-one supervision is a safe adjunct therapy associated with improvements in cardiopulmonary function and select PROs during neoadjuvant chemotherapy.
authors: Duke University Medical Center , Durham, North Carolina , USA.
authors: Whitney E
authors: WE
authors: Hornsby
authors: Pamela S
authors: PS
authors: Douglas
authors: Miranda J
authors: MJ
authors: West
authors: Aarti A
authors: AA
authors: Kenjale
authors: Amy R
authors: AR
authors: Lane
authors: Emily R
authors: ER
authors: Schwitzer
authors: Kaitlin A
authors: KA
authors: Ray
authors: James E
authors: JE
authors: Herndon
authors: April
authors: A
authors: Coan
authors: Antonio
authors: A
authors: Gutierrez
authors: Kyle P
authors: KP
authors: Hornsby
authors: Erika
authors: E
authors: Hamilton
authors: Lee G
authors: LG
authors: Wilke
authors: Gretchen G
authors: GG
authors: Kimmick
authors: Jeffrey M
authors: JM
authors: Peppercorn
authors: Lee W
authors: LW
authors: Jones
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000473:pathology / Q000628:therapy*; D018270:Carcinoma, Ductal, Breast / Q000473:pathology / Q000628:therapy*; D018275:Carcinoma, Lobular / Q000473:pathology / Q000628:therapy*; D017024:Chemotherapy, Adjuvant; D003131:Combined Modality Therapy; D003520:Cyclophosphamide / Q000008:administration & dosage; D004317:Doxorubicin / Q000008:administration & dosage; D005080:Exercise Test; D005081:Exercise Therapy; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D009367:Neoplasm Staging; D011379:Prognosis; D012449:Safety
chemical_list: D004317:Doxorubicin; D003520:Cyclophosphamide