CancerPROGRESSNCT05723471
Impact of a Collaborative Program of Physical Activity of Newly-diagnosed Cancer Patients
A study testing Adaptative Physical Activity in people with Cancer, run by University Hospital, Toulouse at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Adaptative Physical Activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 2 sitesFrance
- Study dates
- 30 Aug 2024to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- newly-diagnosed cancer patient
- able to start a program of physical activity within the first year follow diagnosis
- performance status between 0 to 2
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
CHRU de Nancy
Nancy, France, 54511
Mathias POUSSEL, MD, PhD, 0383155520 ext. 33, m.poussel@chru-nancy.fr
- Recruiting
Stéphanie MOTTON
Toulouse, France, 31059
Stéphanie MOTTON, MD, 0531155385 ext. 33, motton.stephanie@iuct-oncopole.fr
About this study
Official title: Impact of a Collaborative Program of Customized, Adaptive and Supervised Physical Activity on Adherence, Fitness, Quality of Life and Resilience of Newly-diagnosed Cancer Patients
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.
Read the detailed description
This is a multicenter, two-arm parallel-group randomizes (in a 1:1 ratio), open-label, controlled intervention clinical trial of the comparison of long term adherence to physical activity between an adaptative, customized and collaborative exercise program and standard exercise prescription in patients with newly diagnosed cancer.
- Conditions
- Cancer
- Being tested
- Adaptative Physical Activity
- Keywords
- Adaptative physical activity, Cancer, Quality of Life
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adaptative Physical ActivityOther
12 weeks of a collaborative program of customized, adaptative and supervised physical activity by sports instructor
| Study group | Role | What they receive |
|---|---|---|
| Adaptative Physical Activity | Experimental | Not described Receives: Other: Adaptative Physical Activity |
| Standard Exercise | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of physical activity session
improvement of long-term adhesion to physical activity
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2023
- Study start30 Aug 2024
- Primary completion1 May 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stéphanie MOTTON, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05723471
- Sponsor's protocol ID
- RC31/21/0600
- Acronym
- PROGRESS
- Status last verified
- Apr 2025
- First submitted
- 16 Nov 2022
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Collaborative Program of Customized, Adaptive and Supervised Physical Activity on Adherence, Fitness, Quality of Life and Resilience of Newly-diagnosed Cancer Patients
- ClinicalTrials.gov ID
- NCT05723471
- Acronym / sponsor ID
- PROGRESS / RC31/21/0600
- Conditions
- Cancer
- Keywords
- Adaptative physical activity, Cancer, Quality of Life
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 30 Aug 2024 (actual)
- Primary completion
- 1 May 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 10 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a multicenter, two-arm parallel-group randomizes (in a 1:1 ratio), open-label, controlled intervention clinical trial of the comparison of long term adherence to physical activity between an adaptative, customized and collaborative exercise program and standard exercise prescription in patients with newly diagnosed cancer.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adaptative Physical Activity | Experimental | Other: Adaptative Physical Activity |
| Standard Exercise | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- newly-diagnosed cancer patient
- able to start a program of physical activity within the first year follow diagnosis
- performance status between 0 to 2
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adaptative Physical Activity12 weeks of a collaborative program of customized, adaptative and supervised physical activity by sports instructor | Other | Adaptative Physical Activity |
Primary outcome
Number of physical activity session
Time frame: 2 years
improvement of long-term adhesion to physical activity
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stéphanie MOTTON, MD principal investigator
University Hospital, Toulouse
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adaptative Physical Activity in people with Cancer, run by University Hospital, Toulouse at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura BOGDANOVITCH (0561778437 ext. 33, bogdanovitch.l@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of physical activity session (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2025.