NCT02184663

Evaluation of an Adapted Physical Activity Program in Patients With Unresectable Pancreatic Cancer

Multicenter, Randomized Study, Evaluation of Adapted Physical Activity Program in Patients With Unresectable, Locally Advanced or Metastatic Pancreatic Cancer

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 313 (actual)
• Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Adapted Physical Activity (APA) program may provide an opportunity to improve symptoms for patients with unresectable pancreatic cancer. Thereby, it is proposed to conduct an open trial to assess effects of the APA program in such population

Detailed description

The benefit of Adapted Physical Activity (APA) has been demonstrated after cancer diagnosis in term of symptomatic improvement: reducing fatigue, pain and improving the quality of life, psychological and emotional state, and adherence to treatment. The aim of the study is to assess the effects of an APA program in pancreatic cancer population treated by usual chemotherapy. 200 randomized patients are required. The program is organized in 16 weeks. During the trial, assessments include: aerobic exercises, muscular strength, six-minute walk test, body composition (bioimpedance, L3 CT-scan), level of physical activity - International Physical Activity Questionnaire - (IPAQ questionnaire), fatigue - Multidimensional Fatigue Inventory - (MFI-20 questionnaire), quality of life - EORTC Quality of Life questionnaire C-30 - (EORTC QLQ-30 questionnaire), depression symptom - Hospital Anxiety and depression scale - (HADS questionnaire), pain (Brief Pain Inventory Short form), and nutritional evaluation (BMI, ingests EVA). Furthermore, relationships between insulin resistance, insulin secretion, Insulin like Growth Factor 1 (IGF-1) and pancreatic carcinogenesis exist. APA may improve the quality of life in decreasing insulin-resistance, insulin secretion and IGF-1.

Conditions

• Unresectable Locally Advanced Cancer
• Metastatic Pancreatic Cancer

Interventions

Type	Name	Description
OTHER	without APA program	Control Arm : chemotherapy alone
OTHER	APA program	Experimental Arm : chemotherapy + APA program during 16 weeks (aerobic and muscular strength exercises)

Timeline

• Start date: 2014-11-20
• Primary completion: 2022-04-21
• Completion: 2023-12-30
• First posted: 2014-07-09
• Last updated: 2023-09-28

Locations

17 sites across 1 country: France