Clinical trial NCT01432067: Physical Activity Advices to Prevent Loss of Autonomy in Cancer Treated Elderly Patients. An Intervention Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Elderly Population
Keywords: cancer
geriatry
curative care
physical activity
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2011-09-12
Enrollment: 302
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: SPPB Score
timeFrame: 1 year
measure: Cognitive skills
timeFrame: 2 years
Secondary outcomes:
measure: Quality of life
timeFrame: 2 years
measure: nutritional status
timeFrame: 2 years
measure: Walking distance over 6 minutes
timeFrame: inclusion, 6 months and 1 year
measure: isometric muscle strength measures of upper and lower limbs
timeFrame: 2 years
measure: weight
timeFrame: 2 years
measure: SPPB score
timeFrame: 2 years
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux - Hôpital Saint André
city: Bordeaux
country: France
facility: Institut Bergonié
city: Dax
country: France
facility: CH de Dax
city: Lille
country: France
facility: CHRU Lille
city: Lille
country: France
facility: Centre Oscar Lambret, CLCC Lille
city: Limoges
country: France
facility: CHU de Limoges, Hôpital Dupuytren
city: Mont de Marsan
country: France
facility: CH Mont de Marsan
city: Pessac
country: France
facility: CHU Bordeaux - hôpital Xavier Arnozan
city: Reims
country: France
facility: Institut jean Godinot, CLCC Reims
city: Senlis
country: France
facility: Centre hospitalier de Senlis
city: Vandœuvre-Les-Nancy
country: France
facility: Centre Alexis Vautrin CLCC Nancy
city: Vandœuvre-Les-Nancy
country: France
facility: CHU Nancy hôpital adulte du brabois
Study officials:
affiliation: University Hospital, Bordeaux, France
name: Isabelle BOURDEL MARCHASSON, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Bordeaux, France
name: Adélaïde DOUSSAU, Dr
role: STUDY_CHAIR
References: