MedDataX Logo

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

NCT ID: NCT01432067

Last Updated: 2017-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

302 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-04

Study Completion Date

2016-06-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cancer Elderly Population

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

cancer geriatry curative care physical activity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Adaptated physical activity

Physical activity advices adaptated to physical status of patients

Group Type OTHER

Adapted physical activity

Intervention Type OTHER

Physical activity advices according to a program adapted to physical status of the patient.

Standard physical activity

Daily physical activities based on a standard guide

Group Type OTHER

Classic physical activities

Intervention Type OTHER

Daily physical activities based on a standard guide

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Adapted physical activity

Physical activity advices according to a program adapted to physical status of the patient.

Intervention Type OTHER

Classic physical activities

Daily physical activities based on a standard guide

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Bordeaux

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Isabelle BOURDEL MARCHASSON, Pr

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux, France

Adélaïde DOUSSAU, Dr

Role: STUDY_CHAIR

University Hospital, Bordeaux, France

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CHU de Bordeaux - Hôpital Saint André

Bordeaux, , France

Site Status

Institut Bergonié

Bordeaux, , France

Site Status

CH de Dax

Dax, , France

Site Status

CHRU Lille

Lille, , France

Site Status

Centre Oscar Lambret, CLCC Lille

Lille, , France

Site Status

CHU de Limoges, Hôpital Dupuytren

Limoges, , France

Site Status

CH Mont de Marsan

Mont-de-Marsan, , France

Site Status

CHU Bordeaux - hôpital Xavier Arnozan

Pessac, , France

Site Status

Institut jean Godinot, CLCC Reims

Reims, , France

Site Status

Centre hospitalier de Senlis

Senlis, , France

Site Status

Centre Alexis Vautrin CLCC Nancy

Vandœuvre-lès-Nancy, , France

Site Status

CHU Nancy hôpital adulte du brabois

Vandœuvre-lès-Nancy, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CHUBX 2010/23

Identifier Type: -

Identifier Source: org_study_id