Impact of a Collaborative Program of Physical Activity of Newly-diagnosed Cancer Patients (PROGRESS)

Toulouse University Hospital

Status: Enrolling

Conditions: Cancer

Treatments: Other: Adaptative Physical Activity

Study type: Interventional

Funder types: Other

Identifiers

NCT05723471

RC31/21/0600

Details and patient eligibility

About

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.

Full 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.

Enrollment: 350 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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 design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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350 participants in 2 patient groups

Adaptative Physical Activity

Experimental group

Treatment:

Other: Adaptative Physical Activity

Standard Exercise

No Intervention group