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

Cancer Clinical Trial

— CAPADOGE  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01432067
• Other study ID #: CHUBX 2010/23
• 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
• 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

Related Conditions & MeSH terms

• Cancer
• Elderly Population

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	Vandœuvre-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