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.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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
No
Isabelle BOURDEL MARCHASSON, Pr
Principal Investigator
University Hospital, Bordeaux, France
France: Ministry of Health
CHUBX 2010/23
NCT01432067
October 2011
October 2015
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