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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University Hospital, Bordeaux
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT01432067
First received: September 8, 2011
Last updated: March 31, 2014
Last verified: March 2014
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    MMS test, verbal fluency


Secondary Outcome Measures:
  • Quality of life [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    IPAQ, QLQ-C30, ADL, performance status (ECOG)

  • nutritional status [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Walking distance over 6 minutes [ Time Frame: inclusion, 6 months and 1 year ] [ Designated as safety issue: No ]
  • isometric muscle strength measures of upper and lower limbs [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    microfet2 test

  • weight [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • SPPB score [ Time Frame: 2 years ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT01432067

Contacts
Contact: Isabelle BOURDEL MARCHASSON, Pr 33 (0) 5 57 65 65 71 isabelle.bourdel-marchasson@chu-bordeaux.fr

Locations
France
Institut Bergonié Not yet recruiting
Bordeaux, France, 33076
Contact: Marianne Fonck, Dr       fonck@bergonie.org   
Principal Investigator: Marianne Fonck, Dr         
Centre Oscar Lambret, CLCC Lille Not yet recruiting
Lille, France, 59020
Contact: Véronique Servent, Dr       v-servent@o-lambret.fr   
Principal Investigator: Véronique Servent, Dr         
CHRU Lille Not yet recruiting
Lille, France, 59000
Contact: Jean-Pierre Triboulet, Pr       jp-triboulet@chru.lille.fr   
Principal Investigator: Jean-Pierre Triboulet, Pr         
CHU de Limoges, Hôpital Dupuytren Not yet recruiting
Limoges, France, 87042
Contact: Sandrine Lavau-Denès, Dr       sandrine.lavau-denes@chu-limoges.fr   
Principal Investigator: Sandrine Lavau-Denès, Dr         
Hospices civils de Lyon Sud Not yet recruiting
Lyon, France, 69000
Contact: Marc Bonnefoy, Pr       marc.bonnefoy@chu-lyon.fr   
Principal Investigator: marc Bonnefoy, Pr         
CHU Bordeaux - hôpital Xavier Arnosan Recruiting
Pessac, France, 33604
Contact: Isabelle Bourdel-Marchasson, Pr    05 57 65 65 71    isabelle.bourdel-marchasson@chu-bordeaux.fr   
Contact: Jessica DURRIEU    05 57 65 66 72    jessica.durrieu@chu-bordeaux.fr   
Principal Investigator: Isabelle Bourdel-Marchasson, Pr         
Institut jean Godinot, CLCC Reims Not yet recruiting
Reims, France, 51056
Contact: Brigitte Maget, dr       Brigitte.maget@reims.fnclcc.fr   
Principal Investigator: Brigitte Maget, Dr         
Centre hospitalier de Senlis Not yet recruiting
Senlis, France, 60309
Contact: Elisabeth Carola, Dr       elisabeth.carola@ch-senlis.fr   
Principal Investigator: Elisabeth Carola, Dr         
Centre Alexis Vautrin CLCC Nancy Not yet recruiting
Vandœuvre-Les-Nancy, France, 54511
Contact: Hubert Rousselot, Dr       h.rousselot@nancy.fnclcc.fr   
Principal Investigator: Hubert Rousselot, Dr         
CHU Nancy hôpital adulte du brabois Not yet recruiting
Vandœuvre-Les-Nancy, France, 54511
Contact: Philippe Feugier, Pr       p.feugier@chu-nancy.fr   
Principal Investigator: Philippe Feugier, Pr         
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
Principal Investigator: Isabelle BOURDEL MARCHASSON, Pr University Hospital, Bordeaux, France
Study Chair: Adélaïde DOUSSAU, Dr University Hospital, Bordeaux, France
  More Information

No publications provided

Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT01432067     History of Changes
Other Study ID Numbers: CHUBX 2010/23
Study First Received: September 8, 2011
Last Updated: March 31, 2014
Health Authority: France: Ministry of Health

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

ClinicalTrials.gov processed this record on August 27, 2014