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

Not Applicable

Completed

• Conditions: Elderly Population; Cancer
• Interventions: Other: Classic physical activities; Other: Adapted physical activity

• Registration Number: NCT01432067
• Lead Sponsor: University Hospital, Bordeaux

Brief 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 program targeted on the own capacities of each patient.

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 Timeline

• Study First Submitted: 2011-09-08
• Study First Submitted QC: 2011-09-09
• Study First Posted: 2011-09-12
• Study Start: 2011-10-04
• Primary Completion: 2016-06-10
• Study Completion: 2016-06-10
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-07
• Last Update Posted: 2017-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 302

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard physical activity	Classic physical activities	Daily physical activities based on a standard guide
Adaptated physical activity	Adapted physical activity	Physical activity advices adaptated to physical status of patients

Primary Outcome Measures

Name	Time	Method
Cognitive skills	2 years	MMS test, verbal fluency
SPPB Score	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.

Secondary Outcome Measures

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

Trial Locations

Locations (12)

CHU de Limoges, Hôpital Dupuytren; 🇫🇷 Limoges, France

Institut jean Godinot, CLCC Reims; 🇫🇷 Reims, France

CHU Bordeaux - hôpital Xavier Arnozan; 🇫🇷 Pessac, France

CH Mont de Marsan; 🇫🇷 Mont de Marsan, France

Centre Alexis Vautrin CLCC Nancy; 🇫🇷 Vandœuvre-Les-Nancy, France

CHU Nancy hôpital adulte du brabois; 🇫🇷 Vandœuvre-Les-Nancy, France

CH de Dax; 🇫🇷 Dax, France

CHU de Bordeaux - Hôpital Saint André; 🇫🇷 Bordeaux, France

Institut Bergonié; 🇫🇷 Bordeaux, France

CHRU Lille; 🇫🇷 Lille, France

Centre Oscar Lambret, CLCC Lille; 🇫🇷 Lille, France

Centre hospitalier de Senlis; 🇫🇷 Senlis, France