Pancreatic Cancer
Conditions
Keywords
physical activity, physical function, body composition, lean mass, chemotherapy
Brief summary
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
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.
Interventions
OTHERsupervised, hypertrophy-oriented strength training program
12-week supervised, hypertrophy-oriented strength training program in preserving skeletal muscle mass
Sponsors
Universidad Europea de Madrid
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body Composition | Through study completion, an average of 1 year | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| VO2peak | Through study completion, an average of 1 year | • To analyze whether 12 weeks of hypertrophy training in patients with advanced, unresectable pancreatic cancer receiving chemotherapy and/or immunotherapy has an impact on cardiorespiratory capacity. |
| Patient-reported outcome measures | Through study completion, an average of 1 year | • To identify whether 12 weeks of hypertrophy training in patients with advanced, unresectable pancreatic cancer receiving chemotherapy and/or immunotherapy impacts on quality of life. To assess quality of life, the European Organisation for Research and Treatment of Cancer quality of life Questionnaire C30 (EORTC QLQ-C30), version 3.0 will be used. The questionnaire consists of 30 questions grouped into several scales, with higher scores (0-100) indicating better functioning or higher symptom burden. |
| Anxiety and Depression | Through study completion, an average of 1 year | • To determine whether 12 weeks of hypertrophy training in patients with advanced, unresectable pancreatic cancer receiving chemotherapy and/or immunotherapy has an impact on anxiety and depression. It will be assesed through the validated questionnaire for assessing anxiety and depression in cancer patients, the Hospital Anxiety and Depression Scale (HADS). It is a 14-item, self-report screening tool used to identify and monitor emotional distress (anxiety and depression) in patients with physical health conditions. It consists of two subscales (7 questions each for anxiety and depression) and is commonly used in hospital settings. |
Countries
Spain
Outcome results
None listed