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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01432067
Other study ID # CHUBX 2010/23
Secondary ID
Status Completed
Phase N/A
First received September 8, 2011
Last updated November 7, 2017
Start date October 4, 2011
Est. completion date June 10, 2016

Study information

Verified date November 2017
Source University Hospital, Bordeaux
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 302
Est. completion date June 10, 2016
Est. primary completion date June 10, 2016
Accepts healthy volunteers No
Gender All
Age group 70 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Other:
Adapted physical activity
Physical activity advices according to a program adapted to physical status of the patient.
Classic physical activities
Daily physical activities based on a standard guide

Locations

Country Name City State
France CHU de Bordeaux - Hôpital Saint André Bordeaux
France Institut Bergonié Bordeaux
France CH de Dax Dax
France Centre Oscar Lambret, CLCC Lille Lille
France CHRU Lille Lille
France CHU de Limoges, Hôpital Dupuytren Limoges
France CH Mont de Marsan Mont de Marsan
France CHU Bordeaux - hôpital Xavier Arnozan Pessac
France Institut jean Godinot, CLCC Reims Reims
France Centre hospitalier de Senlis Senlis
France Centre Alexis Vautrin CLCC Nancy Vandœuvre-Les-Nancy
France CHU Nancy hôpital adulte du brabois VandÅ“uvre-Les-Nancy

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary Cognitive skills MMS test, verbal fluency 2 years
Secondary Quality of life IPAQ, QLQ-C30, ADL, performance status (ECOG) 2 years
Secondary nutritional status 2 years
Secondary Walking distance over 6 minutes inclusion, 6 months and 1 year
Secondary isometric muscle strength measures of upper and lower limbs microfet2 test 2 years
Secondary weight 2 years
Secondary SPPB score 2 years
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