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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | 12 weeks of hypertrophy training in patients with advanced, unresectable PC receiving chemotherapy and/or immunotherapy |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| supervised, hypertrophy-oriented strength training program | Other | 12-week supervised, hypertrophy-oriented strength training program in preserving skeletal muscle mass |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| VO2peak | • 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. | Through study completion, an average of 1 year |
| Patient-reported outcome measures |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidad Europea de Madrid | Madrid | Madrid | 28670 | Spain |
Data will be available, including de-identified individual participant data, data dictionaries, and study protocols.
Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.
Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact investigacion@universidadeuropea.es
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• 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. |
| Through study completion, an average of 1 year |
| Anxiety and Depression | • 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. | Through study completion, an average of 1 year |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D001519 | Behavior |
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