Precision Physical Exercise for Personalized Onco-Hematology.

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Salamanca

About this trial

Physical exercise, particularly strength training, has become an effective strategy to improve physical function, muscle mass, and quality of life in cancer patients. However, the biological mechanisms underlying these benefits remain poorly understood, especially during active treatment. The PEPOH project (Precision physical Exercise for Personalized Onco-Hematology) proposes a single-center clinical trial conducted at the Fundación del Instituto de Investigación Biomédica de Salamanca (FIBSAL) including five different patient cohorts: lung, colorectal (CRC), and breast cancer, chronic lymphocytic leukemia, and multiple myeloma. Participants will be randomly assigned to either an in-person intervention group, performing a supervised strength training program twice a week for 12 weeks combined with a home-based exercise program, or a control group performing only the home-based program. Biological samples will be collected before and after the intervention for multi-dimensional characterization (Genomics, Transcriptomics, Proteomics and Metabolomics) and systematic integration with parameters of functional capacity, quality of life, psychological well-being, frailty, and body composition. The main objective of the project is to determine biological parameters associated with strength exercise and their relationship with clinical parameters related to prognosis, therapy response and survival. This multi-dimensional approach will enable the detection of exercise adaptation biomarkers and generate knowledge about the mechanisms linking exercise with improved health outcomes in individuals with cancer. PEPOH will contribute to biomedical science and will enhance the comprehensive care of oncohematologic patients by integrating multi-omic and clinical data into a precision exercise model. This project will also contribute to society by offering a cost-effective, safe, and transferable intervention, which increases the overall quality of life.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients (≥18 years), capable of signing the informed consent and willing to participate in the study.

Performance status (ECOG) 0-2.

Disqualifiers

Presence of unstable bone metastases or extensive bone involvement associated with a high risk of fracture.

Uncontrolled cardiovascular, respiratory, musculoskeletal, or metabolic diseases that contraindicate physical exercise at the investigator's discretion.

Explicit medical contraindication to exercise training.

Documented poor adherence (<80%).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Supervised Intervention

    Other intervention

    A strength training programme conducted twice per week for 12 weeks under professional supervision, complemented by a home-based exercise programme.

  • Home-based Intervention

    Other intervention

    A home-based exercise programme following the same recommendations and guidelines as a supervised group but without supervised in-person sessions.

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Supervised Intervention Grou'pExperimental treatment 2 interventions
Group B: Control GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Functional physical condition

Dynamometry and Short Physical Performance Battery scale

Time frame
36 months

Secondary outcomes

1

Psychological well-being and mental health

Mensured using Hospital anxiety and depression scale

Time frame
36 months
2

Determination of body composition

Body composition will be me asures using Tamita BC-418

Time frame
36 months
3

Sleep quality

Atenas scale will be used

Time frame
36 months
4

Overall Quality of life

European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire will be used

Time frame
36 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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