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Exercise Intervention Study for Pancreatic Cancer Patients (SUPPORT)

G

German Cancer Research Center

Status

Completed

Conditions

Pancreatic Cancer

Treatments

Behavioral: Six months supervised resistance training
Behavioral: Six months home-based exercise training

Study type

Interventional

Funder types

Other

Identifiers

NCT01977066
SUPPORT

Details and patient eligibility

About

The purpose of this study is to compare the effects of two specific exercise interventions and one standard care control arm on physical functioning.The investigators expect that supervised training is most beneficial to the patients. However, they also expect some benefit for patients in the home-based training.

Full description

The randomized-controlled balanced-parallel-group trial included 65 adult pancreatic cancer patients (stage I-IV) from the University Surgery Clinic in Heidelberg. The study compared two specific exercise interventions and one standard care control arm. The intervention programs 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 differed primarily by the intensity and mode-of-administration of the intervention. Both interventions started at the earliest 8 weeks after surgery to allow for wound healing until Maximum 12 months after the surgery. 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, reduced standing or walking ability) were eligible.

The primary objective is to compare the effects of the different interventions on physical functioning, measured as change from baseline to 6 months. Additional endpoints are overall quality of life, fatigue, endurance, and strength performance, adherence to the interventions, discontinuation of adjuvant therapy, body weight and composition, disease progression, overall and progression-free survival. All outcomes has been assessed every 3 months for a minimum follow-up period of 12 months.

Enrollment

65 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Pancreatic cancer patients (stage I-IV)
  • Patients ≥ 18 years of age
  • Resection performed at the University Clinic of Heidelberg
  • Sufficient German language skills
  • Signed informed consent

Exclusion criteria

• Presence of comorbidities that preclude participation in the intervention arms (e.g. severe pain, heart insufficiency, reduced standing or walking ability)

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

65 participants in 3 patient groups

Six months supervised exercise training
Experimental group
Treatment:
Behavioral: Six months supervised resistance training
Six months home-based exercise training
Experimental group
Treatment:
Behavioral: Six months home-based exercise training
Control group
No Intervention group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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