SUPPORT-Study

In cooperation with the Department of General Surgery/University of Heidelberg.

Principal Investigators: Prof. Dr. Karen Steindorf, Prof. Dr. Cornelia Ulrich, Prof. Dr. Jens Werner, Dr. Joachim Wiskemann

Pancreatic cancer is the 4th most common cause of cancer death in Germany. The median survival time of patients with surgical resection increased over the last decades to up to 30 months. Before and shortly after pancreatic resections, the quality of life is dramatically reduced in patients and it improves only slowly after surgery. Thus, quality of life among pancreatic cancer patients has become a major concern. In addition to psychological distress, predominantly the physical functioning, a major component of quality of life, is reduced after a pancreatic resection for cancer. Exercise and resistance training have been found to effectively improve quality of life in patients with various cancer types. However, to date, no systematic resistance training intervention study among pancreatic cancer patients has been reported. The Heidelberg team includes specifically educated training personal and has experience with patients from a wide variety of cancer sites and diverse individual training capacities.

The randomized-controlled balanced-parallel-group were included 65 adult pancreatic cancer patients (stage I-IV) from the University Surgery Clinic in Heidelberg shortly after resection compares two specific exercise interventions and one standard care control arm. The intervention programs of the SUPPORT study were (1) a 6-month supervised moderate-to-high-intensity, progressive resistance training, and (2) a 6-month home-based exercise training. Thus, the two interventions differ primarily by the intensity and mode-of-administration of the intervention. Both interventions started 8-10 weeks after surgery to allow for wound healing. At the beginning of the intervention an individual assessment of the patient’s training capacity will be performed to develop the personalized training program. The supervised progressive training started with only moderate-intensity training during the first 4 weeks. Only patients without comorbidities that preclude participation in the intervention arms (e.g. severe pain, heart insufficiency > NYHA III, reduced standing or walking ability) were eligible.

Our primary objective is to compare the effects of the different interventions on physical functioning, measured as change in the quality of life questionnaire EORTC-QLQ-C30 from baseline to 6 months. Additional endpoints are overall quality of life from EORTC QLQ-C30 and the pancreatic cancer specific module QLQ-PAN26, fatigue, endurance (VO2peak) and strength performance (isometric and isokinetic), adherence to the interventions, discontinuation of adjuvant therapy, body weight and composition, disease progression, overall and progression-free survival. All outcomes were assessed every 3 months for a minimum follow-up period of 12 months.

If the intervention(s) show efficacy, our study will allow supportive care options for the large group of resected pancreatic cancer patients, thus, indicating a high relevance. As long as supervised training facilities for oncologic patients are not yet widespread throughout Germany the home-based option could be relevant for many patients. Empowered by the expected results of this RCT as well as the increasing understanding that patients from various cancer sites benefit from exercise after diagnosis, it can be expected that training facilities with qualified staff will built up throughout Germany over the next years.

The study is supported by the German Cancer Aid.

Recruitment for the SUPPORT study started in October 2013 and until December 2015. Currently the data are evaluated.

Prof. Dr. Karen Steindorf (Study Coordinator)
phone: +49 6221 42 2351
e-mail: karen.steindorf@nct-heidelberg.de

ClinicalTrials.gov registration: NCT01977066

Steindorf K, Clauss D, Tjaden C, Hackert T, Herbolsheimer F, Bruckner T, Schneider L, Ulrich CM, Wiskemann J (2019): Quality of life, fatigue, and sleep problems in pancreatic cancer patients: a randomized controlled trial on the effects of exercise. Deutsches Ärzteblatt International, 116, 471-8, doi: 10.3238/arztebl.2019.0471. 

Wiskemann J, Clauss D, Tjaden C, Hackert T, Schneider L, Ulrich CM, Steindorf K(2019): Progressive resistance training to impact physical fitness and body weight in pancreatic cancer patients: a randomized controlled trial. Pancreas, 48, 257-266.