Precision Physical Exercise for Personalized Onco-Hematology.

NCT07286539 | Not Yet Recruiting DMC

• 1 other identifier: PEPOH
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Hematologic Cancer; Colon Cancer; Breast Cancer; Lymphoma; Chronic Lymphocytic Leukemia (CLL); Lung Cancer

Keywords

Exercise; Cancer; Well-being

Outcome Measures

Primary Outcomes (1)

• Functional physical condition

  Dynamometry and Short Physical Performance Battery scale

  36 months

Secondary Outcomes (7)

• Psychological well-being and mental health

  36 months

• Determination of body composition

  36 months

• Sleep quality

  36 months

• Overall Quality of life

  36 months

• Genomics profiling

  36 months

Study Arms (2)

Supervised Intervention Grou'p

EXPERIMENTAL

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

Other: Supervised Intervention; Other: Home-based Intervention

Control Group

EXPERIMENTAL

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

Other: Home-based Intervention

Interventions

Supervised Intervention OTHER

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

Supervised Intervention Grou'p

Home-based Intervention OTHER

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

Control Group; Supervised Intervention Grou'p

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Lung cancer: Patients diagnosed with non-small cell lung carcinoma in metastatic stage, eligible for combined immunotherapy and chemotherapy, with active treatment.
• Colorectal cancer: Patients with stage II, III, or IV resected colorectal cancer undergoing adjuvant chemotherapy.
• Breast cancer: Female patients with histologically confirmed hormone receptor-positive/HER2-negative breast cancer, receiving active hormonal therapy (tamoxifen, aromatase inhibitor, or fulvestrant) in either adjuvant or stable metastatic phase.
• Chronic lymphocytic leukemia (CLL): Patients diagnosed with CLL who have not received and are not in need of pharmacological treatment.
• Multiple myeloma (MM): Patients with a confirmed new diagnosis of MM under active first line treatment and non-candidates to autologous transplantation.

You may not qualify if:

• 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%).
• Treatment discontinuation, disease progression, intolerance, or any other medical, personal, or logistical circumstance that, in the opinion of the investigators, may compromise participant safety or the integrity of the study.

Sponsors & Collaborators

• University of Salamanca: lead

MeSH Terms

Conditions

Hematologic Neoplasms; Colonic Neoplasms; Breast Neoplasms; Lymphoma; Leukemia, Lymphocytic, Chronic, B-Cell; Lung Neoplasms; Motor Activity; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Hematologic Diseases; Hemic and Lymphatic Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Behavior

Central Study Contacts

Carlos Martin-Sanchez, PhD

CONTACT

+34646774655; carlos_ms@usal.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: Population The trial will include five patient cohorts corresponding to the following diagnoses: lung cancer, colorectal cancer, breast cancer, chronic lymphocytic leukemia, and multiple myeloma. Each cohort will consist of 50 patients, resulting in a total sample of 250 patients. After a baseline assessment, patients will be randomly assigned (1:1) to one of two study groups: Supervised intervention group: a strength training programme conducted twice per week for 12 weeks under professional supervision, complemented by a home-based exercise programme. Control group: a home-based exercise programme following the same recommendations and guidelines as a supervised group but without supervised in-person sessions. Assessments will be performed at baseline and after the 12-week intervention, with an additional follow-up at 6 months to analyze the persistence of clinical and molecular effects in the medium term.

Study Record Dates

• First Submitted: November 16, 2025
• First Posted: December 16, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2030
• Last Updated: December 16, 2025

Record last verified: 2025-12