NCT07286539Toborzás még nem indult
Precision Physical Exercise for Personalized Onco-Hematology.
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. dec. 16.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toborzás még nem indult
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 150 (tervezett)
- Első benyújtás
- 2025. nov. 16.
- Kezdés
- 2026. ápr. 1.
- Elsődleges befejezés
- 2026. dec. 31.
- Fő szponzor
- University of Salamanca
- Betegségek
- Vastagbélrák, Krónikus limfoid leukémia (CLL), Tüdőrák
- NCT-szám
- NCT07286539
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 150
- 2026. ápr. 1. és az elsődleges befejezés (2026. dec. 31.) között
- Nincs megadott helyszín, ország nélkül
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
Ki nem vehet részt
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Más betegség
- Uncontrolled cardiovascular, respiratory, musculoskeletal, or metabolic diseases that contraindicate physical exercise at the investigator's discretion.
- 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.
Egyéb
- Presence of unstable bone metastases or extensive bone involvement associated with a high risk of fracture.
- Explicit medical contraindication to exercise training.
- Documented poor adherence (<80%).
A regiszterben nem jelölt feltételek
- Inclusión criteria:
- Adult patients (≥18 years), capable of signing the informed consent and willing to participate in the study.
- Performance status (ECOG) 0-2.
- Specific inclusion criteria are defined for each cohort involved in the study as follows:
- 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.
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
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