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| Effects of a pragmatic home-based exercise program concurrent with neoadjuvant therapy on physical function of patients with pancreatic cancer: the PancFit randomized clinical trial |
| Ngo-Huang AT, Parker NH, Xiao LC, Schadler KL, Petzel MQB, Prakash LR, Kim MP, Tzeng C-WD, Lee JE, Ikoma N, Wolff RA, Javle MM, Koay EJ, Pant SD, Folloder JP, Wang X, Cotto AM, Ju YR, Garg N, Wang H, Bruera ED, Basen-Engquist KM, Katz MHG |
| Annals of Surgery 2023 Jul;278(1):22-30 |
| clinical trial |
| 4/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: No; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
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OBJECTIVE: To determine the effects of a preoperative, home-based exercise program on fitness and physical function in patients with pancreatic cancer. BACKGROUND: We previously established a well-tolerated preoperative exercise program after finding a high frequency of sarcopenia and frailty in patients with pancreatic cancer. METHODS: In this randomized, controlled trial (NCT03187951), patients with pancreatic cancer were randomized to Arm A: enhanced usual care or Arm B: prescribed aerobic and resistance exercise during neoadjuvant therapy. Patients received nutrition counseling and activity trackers. The primary endpoint was 6-minute walk distance (6MWD; >= 14 meters improvement was clinically meaningful). Secondary endpoints included additional physical function tests, health-related quality of life, and clinical outcomes. RESULTS: 151 patients were randomized. Objective ly measured weekly activity (153.2 +/- 135.6 and 159.8 +/- 122.8 min in Arm A and B, respectively, p = 0.62) and self-reported weekly moderate-to-strenuous physical activity (107.4 +/- 160.4 and 129.6 +/- 161.6 min in Arm A and Arm B, respectively, p = 0.49) were similar, but weekly strength training sessions increased more in Arm B (by 1.8 +/- 1.8 versus 0.1 +/- 2.4 sessions, p < 0.001). 6MWD improved in both Arm A (mean change 18.6 +/- 56.8 m, p = 0.01) and Arm B (27.3 +/- 68.1 m, p = 0.002). Quality of life and clinical outcomes did not significantly differ between arms. Pooling patients in both study groups, exercise and physical activity were favorably associated with physical performance and clinical outcomes. CONCLUSIONS: In this randomized trial of prescribed exercise versus enhanced usual care during neoadjuvant therapy for pancreatic cancer, high volume of activity and increased exercise capacity were observed in both arms, highlighting the importance of activity among patients preparing for surgery.
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