NCT05723471

Brief Summary

During the last twenty years, the cancer overall incidence has been increasing in europe and developed countries, while diagnostic and therapeutic progress have contributes to a reduction in mortality. Currently, almost 4 million people are treated or followed for cancer in France. The physical, psychological and social after-effects are significant. Adaptated physical activity plays an important role in the rehabilitation process. Overall, meta-analyses carried-out with most frequent cancers demonstrate that physical activity practiced would allow an improvement in quality of life, tolerance to anticancer treatments and survival.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
350

participants targeted

Target at P75+ for not_applicable cancer

Timeline
32mo left

Started Aug 2024

Longer than P75 for not_applicable cancer

Geographic Reach
1 country

2 active sites

Status
recruiting

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

Study Progress40%
Aug 2024Dec 2028

First Submitted

Initial submission to the registry

November 16, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 10, 2023

Completed
1.6 years until next milestone

Study Start

First participant enrolled

August 30, 2024

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2028

Expected
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

April 10, 2025

Status Verified

April 1, 2025

Enrollment Period

3.7 years

First QC Date

November 16, 2022

Last Update Submit

April 7, 2025

Conditions

Cancer

Keywords

Adaptative physical activityCancerQuality of Life

Outcome Measures

Primary Outcomes (1)

  • Number of physical activity session

    improvement of long-term adhesion to physical activity

    2 years

Study Arms (2)

Adaptative Physical Activity

EXPERIMENTAL
Other: Adaptative Physical Activity

Standard Exercise

NO INTERVENTION

Interventions

Adaptative Physical ActivityOTHER

12 weeks of a collaborative program of customized, adaptative and supervised physical activity by sports instructor

Adaptative Physical Activity

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • newly-diagnosed cancer patient
  • able to start a program of physical activity within the first year follow diagnosis
  • performance status between 0 to 2

You may not qualify if:

  • uncontrolled cardiovascular disease
  • peripheral neuropathy grade 3-4 with risk of falling
  • bone metastasis with risk of bone fracture
  • platelets \<100X109/L
  • hemoglobin \<8g/dL
  • patient under legal protection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHRU de Nancy

Nancy, France, 54511, France

RECRUITING

Stéphanie MOTTON

Toulouse, France, 31059, France

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Stéphanie MOTTON, MD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura BOGDANOVITCH

CONTACT

0561778437bogdanovitch.l@chu-toulouse.fr

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

November 16, 2022

First Posted

February 10, 2023

Study Start

August 30, 2024

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

April 10, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)