NCT01432067

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
302

participants targeted

Target at P75+ for not_applicable cancer

Timeline
Completed

Started Oct 2011

Longer than P75 for not_applicable cancer

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 8, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2011

Completed
22 days until next milestone

Study Start

First participant enrolled

October 4, 2011

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2016

Completed
Last Updated

November 8, 2017

Status Verified

November 1, 2017

Enrollment Period

4.7 years

First QC Date

September 8, 2011

Last Update Submit

November 7, 2017

Conditions

CancerElderly Population

Keywords

cancergeriatrycurative carephysical activity

Outcome Measures

Primary Outcomes (2)

  • 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

  • Cognitive skills

    MMS test, verbal fluency

    2 years

Secondary Outcomes (6)

  • Quality of life

    2 years

  • nutritional status

    2 years

  • Walking distance over 6 minutes

    inclusion, 6 months and 1 year

  • isometric muscle strength measures of upper and lower limbs

    2 years

  • weight

    2 years

  • +1 more secondary outcomes

Study Arms (2)

Adaptated physical activity

OTHER

Physical activity advices adaptated to physical status of patients

Other: Adapted physical activity

Standard physical activity

OTHER

Daily physical activities based on a standard guide

Other: Classic physical activities

Interventions

Adapted physical activityOTHER

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

Adaptated physical activity
Classic physical activitiesOTHER

Daily physical activities based on a standard guide

Standard physical activity

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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)
  • +6 more criteria

You may not qualify if:

  • Palliative cares for cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

CHU de Bordeaux - Hôpital Saint André

Bordeaux, 33000, France

Location

Institut Bergonié

Bordeaux, 33076, France

Location

CH de Dax

Dax, France

Location

CHRU Lille

Lille, 59000, France

Location

Centre Oscar Lambret, CLCC Lille

Lille, 59020, France

Location

CHU de Limoges, Hôpital Dupuytren

Limoges, 87042, France

Location

CH Mont de Marsan

Mont-de-Marsan, France

Location

CHU Bordeaux - hôpital Xavier Arnozan

Pessac, 33604, France

Location

Institut jean Godinot, CLCC Reims

Reims, 51056, France

Location

Centre hospitalier de Senlis

Senlis, 60309, France

Location

Centre Alexis Vautrin CLCC Nancy

Vandœuvre-lès-Nancy, 54511, France

Location

CHU Nancy hôpital adulte du brabois

Vandœuvre-lès-Nancy, 54511, France

Location

MeSH Terms

Conditions

NeoplasmsMotor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Isabelle BOURDEL MARCHASSON, Pr

    University Hospital, Bordeaux, France

    PRINCIPAL INVESTIGATOR

  • Adélaïde DOUSSAU, Dr

    University Hospital, Bordeaux, France

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2011

First Posted

September 12, 2011

Study Start

October 4, 2011

Primary Completion

June 10, 2016

Study Completion

June 10, 2016

Last Updated

November 8, 2017

Record last verified: 2017-11

Locations

FR(12)