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Clinical Trials/NCT01432067
NCT01432067CompletedNot Applicable

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

University Hospital, Bordeaux23 sites in 1 country302 target enrollmentStarted: October 4, 2011Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
302
Locations
23
Primary Endpoint
SPPB Score

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
70 Years to — (Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Adaptated physical activity

Other

Physical activity advices adaptated to physical status of patients

Intervention: Adapted physical activity (Other)

Standard physical activity

Other

Daily physical activities based on a standard guide

Intervention: Classic physical activities (Other)

Outcomes

Primary Outcomes

SPPB Score

Time Frame: 1 year

The main outcome will be the proportion of subjects with a one-year decreased SPPB score of one point or more in 12.

Cognitive skills

Time Frame: 2 years

MMS test, verbal fluency

Secondary Outcomes

  • Walking distance over 6 minutes(inclusion, 6 months and 1 year)
  • Quality of life(2 years)
  • isometric muscle strength measures of upper and lower limbs(2 years)
  • weight(2 years)
  • SPPB score(2 years)
  • nutritional status(2 years)

Investigators

Sponsor
University Hospital, Bordeaux
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (23)

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