Impact of Hypertrophy-oriented Resistance Training on Muscle Mass and Quality of Life in Patients With Unresectable Pancreatic Cancer

Brief summary public domain (ClinicalTrials.gov)

To determine the efficacy of a 12-week supervised, hypertrophy-oriented strength training program in preserving skeletal muscle mass, physical function, and quality of life in patients with unresectable pancreatic cancer compared to standard care.

Detailed description public domain (ClinicalTrials.gov)

Two-arm randomized controlled trial will recruit patients with unresectable pancreatic cancer undergoing chemotherapy. Participants will be randomized (1:1) to an Intervention Group (resistance training twice weekly) or a Control Group (standard care). The primary outcome is the change in total lean body mass (assessed by DXA) at week 12. Secondary outcomes include maximal strength, peak power, cardiorespiratory capacity, and patient-reported measures.

Intervention public domain (ClinicalTrials.gov)

Other: supervised, hypertrophy-oriented strength training program. 12-week supervised, hypertrophy-oriented strength training program in preserving skeletal muscle mass

Arm public domain (ClinicalTrials.gov)

Intervention Group (experimental): 12 weeks of hypertrophy training in patients with advanced, unresectable PC receiving chemotherapy and/or immunotherapy

Arm public domain (ClinicalTrials.gov)

Control Group (no intervention): Participants in the control group will receive standard oncological treatment. No restrictions on physical activity will be imposed. Furthermore, they will be offered the opportunity to follow the exercise program used in the intervention group if the expected benefits proposed in the study hypothesis are confirmed.

Primary outcome public domain (ClinicalTrials.gov)

Body Composition. The main objective of this study is to evaluate the effect on body composition (primarily lean mass) through 12 weeks of hypertrophy training in patients with advanced, non-operable pancreatic cancer undergoing treatment Time frame: Through study completion, an average of 1 year.

Secondary outcome public domain (ClinicalTrials.gov)

VO2peak. Time frame: Through study completion, an average of 1 year.

Secondary outcome public domain (ClinicalTrials.gov)

Patient-reported outcome measures. Time frame: Through study completion, an average of 1 year.

Secondary outcome public domain (ClinicalTrials.gov)

Anxiety and Depression. Time frame: Through study completion, an average of 1 year.

Eligibility public domain (ClinicalTrials.gov)

Inclusion Criteria: * Diagnosis of locally advanced or metastatic unresectable pancreatic cancer * Undergoing chemotherapy or immunotherapy treatment * Age ≥ 18 years * ECOG score ≤ 2 Exclusion Criteria: * Any relative or absolute contraindication that prevents the performance of training or physical tests. * Diagnosis of other types of primary cancer * Inability to understand Spanish for proper comprehension of the informed consent and questionnaires

Enrollment public domain (ClinicalTrials.gov)

Enrollment: 10 participants (estimated).