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Randomized Controlled Trial
. 2024 Jun 15;32(7):437.
doi: 10.1007/s00520-024-08650-9.

P-move: a randomized control trial of exercise in patients with advanced pancreatic or biliary tract cancer (aPBC) receiving beyond first-line chemotherapy

Nico De Lazzari  1   2   3 , Miriam Götte  2 , Stefan Kasper  1   4   5 , Eileen Meier  1   6 , Martin Schuler  1   4   5 , Michael Pogorzelski  1 , Jens T Siveke  1   7   4   6   5 , Mitra Tewes  8
Affiliations
Randomized Controlled Trial

P-move: a randomized control trial of exercise in patients with advanced pancreatic or biliary tract cancer (aPBC) receiving beyond first-line chemotherapy

Nico De Lazzari et al. Support Care Cancer. .

Abstract

Purpose: Patients with advanced pancreatic and biliary tract cancer (aPBC) frequently suffer from high symptom burden. Exercise can reduce treatment side effects and improve patient-related outcomes (PROMs). However, evidence from prospective studies regarding feasibility and efficacy in advanced settings are sparse. The primary aim of this prospective, randomized-controlled study was to evaluate the feasibility and effects of exercise (ET) in patients with aPBC.

Methods: Patients with aPBC beyond first-line therapy were randomized according to the minimization procedure with stratification by gender, age, and loss of body weight in the past six months. The intervention group (IG) completed 3 training units/week for 8 weeks (1x supervised strength sessions, 2x individualized home-based sessions). Control group (CG) received recommendations on physical activity during cancer.

Results: 41 patients (stage IV pancreatic or biliary tract cancer) were included no adverse events related to exercise occurred during the trial. Physical function increased significantly in IG in 5 out of 7 physical domains. Comparison of IG and CG at 8 weeks (t2) showed significant differences in favour of IG in leg press (p=0.001), bench press (p=0.011), sit-to-stand (p=0.001) and crunch (0.006). Constipation revealed a significant difference in favour of IG at t2 (p=0.033). Quality of life stabilized/increased in IG during the study period compared to a decrease in CG. Throughout/Over the 8 weeks, fatigue notably reduced in the IG (p=0.028).

Conclusion: Exercise is safe and feasible in patients with aPBC undergoing further line therapy. Significant improvements in physical functioning and increased quality of life were achieved. German Clinical Trials Register ID: DRKS00021179; Registration date 15.05.2020.

Keywords: Cancer cachexia; Palliative chemotherapy; Pancreatobiliary cancer; Physical activity; Strength training.

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Conflict of interest statement

J.T.S. receives honoraria as consultant or for continuing medical education presentations from AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Immunocore, MSD Sharp Dohme, Novartis, Roche/Genentech, and Servier. His institution receives research funding from Abalos Therapeutics, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Eisbach Bio, and Roche/Genentech; he holds ownership in FAPI Holding (<3%); all outside the submitted work.

S.K. received honoraria from Merck Serono, MSD, Novartis, BMS, Amgen, Roche, Sanofi-Aventis, Servier, Incyte and Lilly; research funding from Merck Serono, Lilly, BMS, Roche.

The other authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
CONSORT flow diagram
Fig. 2
Fig. 2
Physical function data at all 3 measurement points (t0,t1,t2) displayed. Significant difference between groups and intragroup differences are shown with p-values. Full test statistics are listed in the results text
See this image and copyright information in PMC

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