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

  • STATUS
    Recruiting
  • End date
    Dec 23, 2021
  • participants needed
    317
  • sponsor
    GERCOR - Multidisciplinary Oncology Cooperative Group
Updated on 23 January 2021
cancer
measurable disease
pancreatic adenocarcinoma
adenocarcinoma
unresectable pancreatic cancer

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

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.

Details
Condition Metastatic Pancreatic Cancer, Unresectable Locally Advanced Cancer
Treatment without APA program, APA program
Clinical Study IdentifierNCT02184663
SponsorGERCOR - Multidisciplinary Oncology Cooperative Group
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Histologically proven non resectable pancreatic adenocarcinoma
Indication of palliative chemotherapy
Life expectancy 3 months
Eastern Cooperative oncology group (ECOG) - Performance status 2
Age 18 years old
At least one measurable lesion as assessed by CT-scan or MRI (Magnetic resonance Imaging)
Identified Accompanying partner Adapted Physical Activity (AAPA)
Signed and dated informed consent
Registration in a National Health Care System (CMU included for France)

Exclusion Criteria

Previous Cerebrovascular accident or myocardial infarction <6months
Uncontrolled hypertension
Severe cardiovascular or respiratory disease
Severe cognitive or psychiatric disorder
Severe motor and/or sensory neuropathy
Rheumatologic or orthopedic problem or bone lesions with a fracture risk
Others comorbidities contra-indicated physical exercises
Patient protected by the law - Guardianship and trusteeship
Clear my responses

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