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NCT Number: NCT01432067

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

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Key information

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Bordeaux - Hôpital Saint André, Bordeaux, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

adapted physical activity

Other

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

Classic physical activities

Other

Daily physical activities based on a standard guide

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Acronym: CAPADOGE

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Sep 12, 2011
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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