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CancerCAPADOGENCT01432067

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

A study testing Adapted physical activity and Classic physical activities in people with Cancer and Elderly Population, run by University Hospital, Bordeaux at 12 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 70 years and older
Conditions the study is for
Cancer, Elderly Population
What is being tested?
Adapted physical activity and Classic physical activities
Could I receive a placebo?
No, everyone receives an active treatment
How many people
302 participants
Where
12 sitesFrance
Study dates
4 Oct 2011to 10 Jun 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 70 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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
Show all 21Show fewer
  • 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

Who cannot join

  • Palliative cares for cancer

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

France12 sites

  • CHU de Bordeaux - Hôpital Saint André

    Bordeaux, 33000

  • Institut Bergonié

    Bordeaux, 33076

  • CH de Dax

    Dax

  • CHRU Lille

    Lille, 59000

  • Centre Oscar Lambret, CLCC Lille

    Lille, 59020

  • CHU de Limoges, Hôpital Dupuytren

    Limoges, 87042

  • CH Mont de Marsan

    Mont-de-Marsan

  • CHU Bordeaux - hôpital Xavier Arnozan

    Pessac, 33604

  • Institut jean Godinot, CLCC Reims

    Reims, 51056

  • Centre hospitalier de Senlis

    Senlis, 60309

  • Centre Alexis Vautrin CLCC Nancy

    Vandœuvre-lès-Nancy, 54511

  • CHU Nancy hôpital adulte du brabois

    Vandœuvre-lès-Nancy, 54511

Other trials in France

About this study

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.

Read the 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.

Being tested
Adapted physical activity, Classic physical activities
Keywords
cancer, geriatry, curative care, physical activity
Medical subject headings
Neoplasms, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Adapted physical activityOther

    Physical activity advices according to a program adapted to physical status of the patient.

  • Classic physical activitiesOther

    Daily physical activities based on a standard guide

Study groups in NCT01432067
Study groupRoleWhat they receive
Adaptated physical activityOtherPhysical activity advices adaptated to physical status of patients
Receives: Other: Adapted physical activity
Standard physical activityOtherDaily physical activities based on a standard guide
Receives: Other: Classic physical activities

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. SPPB Score

    The main outcome will be the proportion of subjects with a one-year decreased SPPB score of one point or more in 12.

    Measured: 1 year

  2. Cognitive skills

    MMS test, verbal fluency

    Measured: 2 years

Secondary outcomes (6)

  1. Quality of life

    IPAQ, QLQ-C30, ADL, performance status (ECOG)

    Measured: 2 years

  2. nutritional status

    Measured: 2 years

  3. Walking distance over 6 minutes

    Measured: inclusion, 6 months and 1 year

  4. isometric muscle strength measures of upper and lower limbs

    microfet2 test

    Measured: 2 years

  5. weight

    Measured: 2 years

  6. SPPB score

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Sep 2011 (estimated)
  2. Study start4 Oct 2011
  3. Primary completion10 Jun 2016
  4. Study completion10 Jun 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
302 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01432067
Sponsor's protocol ID
CHUBX 2010/23
Other IDs
2010-A01298-31
Acronym
CAPADOGE
Status last verified
Nov 2017
First submitted
8 Sep 2011
Last updated
14 May 2026
Results posted
No
Data monitoring committee
No

Publications

  • Durrieu J, Doussau A, Rieger A, Terrebonne E, Bouabdallah K, Zwolakowski MD, Maget B, Dauba J, Mariette C, Trager S, Perie JL, Robert B, Regueme SC, Bourdel-Marchasson I. Design of a Physical Activity Program to Prevent Functional Decline in Onco-Geriatric Patients (CAPADOGE): A Randomized Multicenter Trial. J Frailty Aging. 2012;1(3):138-43. doi: 10.14283/jfa.2012.22.

    PubMed 27093202

  • Dechamps A, Diolez P, Thiaudiere E, Tulon A, Onifade C, Vuong T, Helmer C, Bourdel-Marchasson I. Effects of exercise programs to prevent decline in health-related quality of life in highly deconditioned institutionalized elderly persons: a randomized controlled trial. Arch Intern Med. 2010 Jan 25;170(2):162-9. doi: 10.1001/archinternmed.2009.489.

    PubMed 20101011

  • Arrieta H, Astrugue C, Regueme S, Durrieu J, Maillard A, Rieger A, Terrebonne E, Laurent C, Maget B, Servent V, Lavau-Denes S, Dauba J, Fonck M, Thiebaut R, Bourdel-Marchasson I. Effects of a physical activity programme to prevent physical performance decline in onco-geriatric patients: a randomized multicentre trial. J Cachexia Sarcopenia Muscle. 2019 Apr;10(2):287-297. doi: 10.1002/jcsm.12382. Epub 2019 Mar 4.

    PubMed 30829460

Questions about this trial

What is this clinical trial studying?

A study testing Adapted physical activity and Classic physical activities in people with Cancer and Elderly Population, run by University Hospital, Bordeaux at 12 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

SPPB Score (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01432067, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.

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