Overview

This trial is active, not recruiting.

Conditions cancer, elderly population
Treatments adapted physical activity, classic physical activities
Sponsor University Hospital, Bordeaux
Start date October 2011
End date January 2016
Trial size 400 participants
Trial identifier NCT01432067, CHUBX 2010/23

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
Arm
(Other)
Physical activity advices adaptated to physical status of patients
adapted physical activity
Physical activity advices according to a program adapted to physical status of the patient.
(Other)
Daily physical activities based on a standard guide
classic physical activities
Daily physical activities based on a standard guide

Primary Outcomes

Measure
SPPB Score
time frame: 1 year
Cognitive skills
time frame: 2 years

Secondary Outcomes

Measure
Quality of life
time frame: 2 years
nutritional status
time frame: 2 years
Walking distance over 6 minutes
time frame: inclusion, 6 months and 1 year
isometric muscle strength measures of upper and lower limbs
time frame: 2 years
weight
time frame: 2 years
SPPB score
time frame: 2 years

Eligibility Criteria

Male or female participants at least 70 years old.

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

Additional Information

Principal investigator Isabelle BOURDEL MARCHASSON, Pr
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2014.
Information provided to ClinicalTrials.gov by University Hospital, Bordeaux.