Effects of intensive physiotherapy on Quality of Life (QoL) after pancreatic cancer resection: a randomized controlled trial.

BACKGROUND

Patients have significantly lower QoL scores after pancreatic resection due to cancer in the physical and psychological domains compared to healthy controls or other cancer patients. Intensified physiotherapy or physical training can increase QoL by reducing fatigue levels and improving physical functioning. However, data on the long-term effects of intensive or supervised physiotherapy is lacking. The aim of this exploratory study is the assessment of QoL in the intervention group, using various QoL questionnaires in their validated German translations and gather data on its feasibility in the context of chemotherapy with a follow-up of 12 months (and develop concepts to improve QoL after pancreatic cancer resection).

METHODS

Fifty-six patients (mean age: 66.4 ± 9.9 years) were randomized in this study to intervention (cohort A, n = 28) or control group (cohort B, n = 28). Intervention of intensified physiotherapy program consisted of endurance and muscle force exercises using cycle ergometer. In the control group physiotherapy was limited to the duration of the hospital stay and was scheduled for 20 min on 5 days per week. The clinical visits took place 2 days preoperatively, 1 week, 3 months, 6 months and 12 months postoperatively. Both groups attended the follow-up program. QoL was evaluated using the Short Physical Performance Battery (SPPB), Short Form-8 Health Survey (SF-8) and the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and pancreatic cancer-specific module QLQ-PAN26 questionnaires. The course of QoL was evaluated using a repeated measures ANOVA and a per protocol design.

RESULTS

Of the initial 56 randomized patients, 34 finished the 12 months follow-up period. There were no adverse events due to the intervention and 80% of patients in the intervention group where adherent. There was no significant influence on physical performance as measured by SPPB and SF-8 questionnaire. However, after 6 months patients in the intervention group regained their prior physical condition, whereas the control group did not. Intensive physiotherapy significantly influenced various factors of QoL measured with the C30 questionnaire positively, such as physical functioning (p = 0.018), role functioning (p = 0.036), and appetite loss (p = 0.037), even after 6 months. No negative effects in patients undergoing chemotherapy compared to those without chemotherapy was observed.

CONCLUSION

This first randomized controlled study with a 12-month follow-up shows that supervised physiotherapy or prescribed home-based exercise after pancreatic cancer resection is safe and feasible and should be proposed and started as soon as possible to improve certain aspects of QoL.

TRIAL REGISTRATION

German Clinical Trials Register (No: DRKS00006786 ); Date of registration: 01/10/2014.