This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2014 by University Hospital, Bordeaux.
Recruitment status was:  Active, not recruiting
Information provided by (Responsible Party):
University Hospital, Bordeaux Identifier:
First received: September 8, 2011
Last updated: September 29, 2014
Last verified: September 2014
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 Intervention
Cancer Elderly Population Other: Adapted physical activity Other: Classic physical activities

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care

Resource links provided by NLM:

Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:
  • 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.

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

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

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

  • weight [ Time Frame: 2 years ]
  • SPPB score [ Time Frame: 2 years ]

Estimated Enrollment: 400
Study Start Date: October 2011
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.


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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

Responsible Party: University Hospital, Bordeaux Identifier: NCT01432067     History of Changes
Other Study ID Numbers: CHUBX 2010/23
Study First Received: September 8, 2011
Last Updated: September 29, 2014

Keywords provided by University Hospital, Bordeaux:
curative care
physical activity processed this record on September 21, 2017