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Physical Activity Advices to Prevent Loss of Autonomy in Cancer Treated Elderly Patients. An Intervention Randomized Study (CAPADOGE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01432067
Recruitment Status : Completed
First Posted : September 12, 2011
Last Update Posted : November 8, 2017
Information provided by (Responsible Party):
University Hospital, Bordeaux

Brief Summary:
The investigators will propose to older cancer patients with good prognosis (curative care) a randomized trial of adapted physical activity during one year. To increase generalisation of the intervention the investigators intend to compare the PNNS advices (the French National Nutrition and Health Program) to a program targeted on the own capacities of each patient.

Condition or disease Intervention/treatment
Cancer Elderly Population Other: Adapted physical activity Other: Classic physical activities

Detailed Description:

Long-term evolution of successful-treated older patients is not well-known except for survival. They seem more affected by physical than psychological problems. The combined effects of aging, cancer, and treatments on muscle function could have hindered their usual physical activity. Cancer is associated with frailty. Fried and coll have defined a frailty phenotype as a combination of 3 or more of 5 conditions: exhaustion, loss of weight, decreased muscle strength, slow gait speed and low physical activity. Frail subjects have a higher risk of physical or cognitive disability and death. An intervention able to prevent frailty is of great interest for the older cancer patient and their quality of life. An intervention consisting of phone-program in physical activity has been associated with a decrease in self-reported disability in five-year obese survivors from cancer.

Patients will be randomized in two arms (1:1 ratio). Arm 1: Physical activity advices according to a program adapted to physical status of the patient assessed using SPPB (short physical performance battery) and the IPAQ questionnaire. A monthly phone support during one year will be performed by an adapted physical activity instructor and delivery of PNNS guide for subjects older than 55 y old. Arm 2: Delivery of PNNS guide for subjects older than 55 year old: recommendation of 1/2 hour physical activity of any kind.

Each patient will be followed during 2 years: First visit (V1) will take place before treatment. The subsequent visits will take place at 3 months (V2), 6 months (V3), 1 year (V4), 18 months (V5) and 2 years (V6), in which patients will complete questionnaires (IPAQ, QLQ-C30, one day dietary intakes), have clinical examinations (weight, performance status/ ECOG) and will be tested for physical facilities (SPPB, micro-fet2). These evaluations will be completed by the MMS / Fluency tests and the covered distance during 6 minutes at V1, V3, and V4.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 302 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Actual Study Start Date : October 4, 2011
Primary Completion Date : June 10, 2016
Study Completion Date : June 10, 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Adaptated physical activity
Physical activity advices adaptated to physical status of patients
Other: Adapted physical activity
Physical activity advices according to a program adapted to physical status of the patient.
Standard physical activity
Daily physical activities based on a standard guide
Other: Classic physical activities
Daily physical activities based on a standard guide

Primary Outcome Measures :
  1. SPPB Score [ Time Frame: 1 year ]
    The main outcome will be the proportion of subjects with a one-year decreased SPPB score of one point or more in 12.

  2. Cognitive skills [ Time Frame: 2 years ]
    MMS test, verbal fluency

Secondary Outcome Measures :
  1. Quality of life [ Time Frame: 2 years ]
    IPAQ, QLQ-C30, ADL, performance status (ECOG)

  2. nutritional status [ Time Frame: 2 years ]
  3. Walking distance over 6 minutes [ Time Frame: inclusion, 6 months and 1 year ]
  4. isometric muscle strength measures of upper and lower limbs [ Time Frame: 2 years ]
    microfet2 test

  5. weight [ Time Frame: 2 years ]
  6. SPPB score [ Time Frame: 2 years ]

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Ages Eligible for Study:   70 Years and older   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 70 years old or older
  • Curative cares for cancer by chemotherapy and/ or surgery and/or hormonotherapy and/ or radiotherapy
  • Patient with histologically proven lymphoma or carcinoma :

    • Colon, rectum or anal canal Cancer
    • Breast Cancer
    • Esophageal cancer
    • Otolaryngology Cancer
    • Kidney cancer
    • hepatocellular carcinoma
    • Stomach Cancer
    • Pancreatic cancer
    • Bile duct cancer
    • Ovarian Cancer
    • All lymphoma diffuse large B-cell and all peripheral T-cells lymphomas
    • All low-grade lymphoma: lymphocytes, lymphocytes and plasma cells, follicular, mantle, marginal zone (MALT and others)
    • Prostate cancer
    • Bladder Cancer
    • Lung cancer
    • adenocarcinoma of unknown primary origin compatible with previous quoted origin
  • Performance status (ECOG) <4
  • Patient who had given oral consent to participate in the study

Exclusion Criteria:

  • Palliative cares for cancer

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01432067

CHU de Bordeaux - Hôpital Saint André
Bordeaux, France, 33000
Institut Bergonié
Bordeaux, France, 33076
CH de Dax
Dax, France
CHRU Lille
Lille, France, 59000
Centre Oscar Lambret, CLCC Lille
Lille, France, 59020
CHU de Limoges, Hôpital Dupuytren
Limoges, France, 87042
CH Mont de Marsan
Mont de Marsan, France
CHU Bordeaux - hôpital Xavier Arnozan
Pessac, France, 33604
Institut jean Godinot, CLCC Reims
Reims, France, 51056
Centre hospitalier de Senlis
Senlis, France, 60309
Centre Alexis Vautrin CLCC Nancy
Vandœuvre-Les-Nancy, France, 54511
CHU Nancy hôpital adulte du brabois
Vandœuvre-Les-Nancy, France, 54511
Sponsors and Collaborators
University Hospital, Bordeaux
Principal Investigator: Isabelle BOURDEL MARCHASSON, Pr University Hospital, Bordeaux, France
Study Chair: Adélaïde DOUSSAU, Dr University Hospital, Bordeaux, France

Responsible Party: University Hospital, Bordeaux Identifier: NCT01432067     History of Changes
Other Study ID Numbers: CHUBX 2010/23
First Posted: September 12, 2011    Key Record Dates
Last Update Posted: November 8, 2017
Last Verified: November 2017

Keywords provided by University Hospital, Bordeaux:
curative care
physical activity