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

GERCOR - Multidisciplinary Oncology Cooperative Group

Status: Active, not recruiting

Conditions: Metastatic Pancreatic Cancer; Unresectable Locally Advanced Cancer

Treatments: Other: APA program; Other: without APA program

Study type: Interventional

Funder types: Other

Identifiers

NCT02184663

APACaP D13-1

2014-A00228-39 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 313 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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313 participants in 2 patient groups

Standard care without APA program

Active Comparator group

Description:

The control arm corresponds to usual care (without APA), including : * Weekday hospital chemotherapy (every 7 or 14 days, depending on chemotherapy protocol) * Evaluation by the oncologist at the usual rate * Assessment every 8 weeks (TAP scan + CA-19.9) * Nutritional, psychological and pain management as recommended, according to the usual schedule.

Treatment:

Other: without APA program

Standard care with APA program

Experimental group

Description:

The experimental arm corresponds to usual care, combined with a 16-week APA program. The APA program consisted of personalized aerobic and resistance exercises, with a weekly remote supervision by an APA professional trainer, and unsupervised sessions with a family member or friend (APA partner).

Treatment:

Other: APA program