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Spots Global Cancer Trial Database for Evaluation of an Adapted Physical Activity Program in Patients With Unresectable Pancreatic Cancer

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Trial Identification

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

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

Study ID: NCT02184663

Study Description

Brief 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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Polyclinique Bordeaux Nord Aquitaine, Bordeaux, , France

CHU Morvan, Brest, , France

Hôpital Beaujon, Clichy, , France

Hôpital Henri Mondor, Creteil, , France

Centre Georges François Leclerc, Dijon, , France

CHD Vendée, La Roche Sur Yon, , France

Institut Hospitalier Franco-Britannique, Levallois Perret, , France

Centre Léon Bérard, Lyon, , France

CH Saint Joseph Saint Luc, Lyon, , France

Hôpital Européen, Marseille, , France

CH Mont de Marsan, Mont de Marsan, , France

Centre Hospitalier de Belfort, Montbéliard, , France

Hôpital Cochin, Paris, , France

Hôpital Saint Antoine, Paris, , France

CHU Robert Debré, Reims, , France

Hôpital FOCH, Suresnes, , France

Institut de cancérologie de Lorraine, Vandoeuvre Les Nancy, , France

Contact Details

Name: Pascal Hammel, MD

Affiliation: Hôpital Beaujon

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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