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

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.

Study Overview

• Status: Completed
• Conditions: Cancer; Elderly Population
• Intervention / Treatment: 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
• Enrollment (Actual): 302
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33076
    • Institut Bergonie
  • Bordeaux, France, 33000
    • CHU de Bordeaux - Hopital Saint Andre
  • Dax, France
    • CH de Dax
  • Lille, France, 59000
    • CHRU Lille
  • Lille, France, 59020
    • Centre Oscar Lambret, CLCC Lille
  • Limoges, France, 87042
    • CHU de Limoges, Hopital Dupuytren
  • Mont de Marsan, France
    • CH Mont de Marsan
  • Pessac, France, 33604
    • CHU Bordeaux - hôpital Xavier Arnozan
  • Reims, France, 51056
    • Institut jean Godinot, CLCC Reims
  • Senlis, France, 60309
    • Centre hospitalier de Senlis
  • Vandœuvre-Les-Nancy, France, 54511
    • Centre Alexis Vautrin CLCC Nancy
  • Vandœuvre-Les-Nancy, France, 54511
    • CHU Nancy hôpital adulte du brabois

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.
Other: Standard physical activity; Daily physical activities based on a standard guide	Other: Classic physical activities; Daily physical activities based on a standard guide

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 year
Cognitive skills	MMS test, verbal fluency	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life	IPAQ, QLQ-C30, ADL, performance status (ECOG)	2 years
nutritional status		2 years
Walking distance over 6 minutes		inclusion, 6 months and 1 year
isometric muscle strength measures of upper and lower limbs	microfet2 test	2 years
weight		2 years
SPPB score		2 years

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Investigators: Principal Investigator: Isabelle BOURDEL MARCHASSON, Pr, University Hospital, Bordeaux, France; Study Chair: Adélaïde DOUSSAU, Dr, University Hospital, Bordeaux, France

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2011
• Primary Completion (Actual): June 10, 2016
• Study Completion (Actual): June 10, 2016

Study Registration Dates

• First Submitted: September 8, 2011
• First Submitted That Met QC Criteria: September 9, 2011
• First Posted (Estimate): September 12, 2011

Study Record Updates

• Last Update Posted (Actual): November 8, 2017
• Last Update Submitted That Met QC Criteria: November 7, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: physical activity; cancer; geriatry; curative care
• Other Study ID Numbers: CHUBX 2010/23