Resistance exercise combined with protein supplementation for skeletal muscle mass in people with pancreatic cancer undergoing neoadjuvant chemotherapy: Study protocol for the REBUILD trial.
<h4>Background</h4>Pancreatic cancer patients' prognosis may be limited by two conditions, cachexia and sarcopenia. Resistance exercise and protein supplementation are safe non-pharmacological strategies that may increase or preserve skeletal muscle mass within this population. Ther...
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Public Library of Science (PLoS)
2025-01-01
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| Series: | PLoS ONE |
| Online Access: | https://doi.org/10.1371/journal.pone.0322192 |
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| author | Paola Gonzalo-Encabo John Gardiner Mary K Norris Rebekah L Wilson Amber J Normann Danny Nguyen Nathan Parker Darryl Tjogas Lauren K Brais Jeffrey A Meyerhardt Michael H Rosenthal Brian M Wolpin Hajime Uno Christina M Dieli-Conwright |
| author_facet | Paola Gonzalo-Encabo John Gardiner Mary K Norris Rebekah L Wilson Amber J Normann Danny Nguyen Nathan Parker Darryl Tjogas Lauren K Brais Jeffrey A Meyerhardt Michael H Rosenthal Brian M Wolpin Hajime Uno Christina M Dieli-Conwright |
| author_sort | Paola Gonzalo-Encabo |
| collection | DOAJ |
| description | <h4>Background</h4>Pancreatic cancer patients' prognosis may be limited by two conditions, cachexia and sarcopenia. Resistance exercise and protein supplementation are safe non-pharmacological strategies that may increase or preserve skeletal muscle mass within this population. Therefore, the primary aim of this study is to examine the feasibility of a home-based virtually supervised resistance exercise intervention, with or without protein supplementation in pancreatic cancer patients initiating neoadjuvant chemotherapy. This intervention may also maintain skeletal muscle mass and improve plasma biomarkers associated with muscle tissue wasting, physical function and psychological measures.<h4>Methods</h4>We aim to recruit 45 patients with locally advanced pancreatic cancer initiating neoadjuvant chemotherapy. Patients will be randomized to receive either Resistance Exercise (RE) (n = 15), Resistance Exercise and Protein Supplementation (RE + PS) (n = 15), or Attention Control (AC) (n = 15). Patients randomized to RE or RE + PS will receive 16-weeks of home-based virtually supervised resistance exercise. The AC will receive a 16-week stretching program. Primary and secondary outcomes will be measured at baseline and after 16 weeks during study visits.<h4>Discussion</h4>The REBUILD trial is the first randomized controlled trial that combines resistance exercise with daily protein supplementation during neoadjuvant chemotherapy in pancreatic cancer patients. Our novel home-based virtually supervised exercise intervention seeks to mitigate barriers to participation in this vulnerable population. Furthermore, results of this trial will address important research gaps associated with pancreatic cancer-related cachexia, a condition closely connected with poor prognosis and mortality. |
| format | Article |
| id | doaj-art-2c1725224ea7477f8c072ab9291cd0ca |
| institution | OA Journals |
| issn | 1932-6203 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | Public Library of Science (PLoS) |
| record_format | Article |
| series | PLoS ONE |
| spelling | doaj-art-2c1725224ea7477f8c072ab9291cd0ca2025-08-20T02:16:09ZengPublic Library of Science (PLoS)PLoS ONE1932-62032025-01-01205e032219210.1371/journal.pone.0322192Resistance exercise combined with protein supplementation for skeletal muscle mass in people with pancreatic cancer undergoing neoadjuvant chemotherapy: Study protocol for the REBUILD trial.Paola Gonzalo-EncaboJohn GardinerMary K NorrisRebekah L WilsonAmber J NormannDanny NguyenNathan ParkerDarryl TjogasLauren K BraisJeffrey A MeyerhardtMichael H RosenthalBrian M WolpinHajime UnoChristina M Dieli-Conwright<h4>Background</h4>Pancreatic cancer patients' prognosis may be limited by two conditions, cachexia and sarcopenia. Resistance exercise and protein supplementation are safe non-pharmacological strategies that may increase or preserve skeletal muscle mass within this population. Therefore, the primary aim of this study is to examine the feasibility of a home-based virtually supervised resistance exercise intervention, with or without protein supplementation in pancreatic cancer patients initiating neoadjuvant chemotherapy. This intervention may also maintain skeletal muscle mass and improve plasma biomarkers associated with muscle tissue wasting, physical function and psychological measures.<h4>Methods</h4>We aim to recruit 45 patients with locally advanced pancreatic cancer initiating neoadjuvant chemotherapy. Patients will be randomized to receive either Resistance Exercise (RE) (n = 15), Resistance Exercise and Protein Supplementation (RE + PS) (n = 15), or Attention Control (AC) (n = 15). Patients randomized to RE or RE + PS will receive 16-weeks of home-based virtually supervised resistance exercise. The AC will receive a 16-week stretching program. Primary and secondary outcomes will be measured at baseline and after 16 weeks during study visits.<h4>Discussion</h4>The REBUILD trial is the first randomized controlled trial that combines resistance exercise with daily protein supplementation during neoadjuvant chemotherapy in pancreatic cancer patients. Our novel home-based virtually supervised exercise intervention seeks to mitigate barriers to participation in this vulnerable population. Furthermore, results of this trial will address important research gaps associated with pancreatic cancer-related cachexia, a condition closely connected with poor prognosis and mortality.https://doi.org/10.1371/journal.pone.0322192 |
| spellingShingle | Paola Gonzalo-Encabo John Gardiner Mary K Norris Rebekah L Wilson Amber J Normann Danny Nguyen Nathan Parker Darryl Tjogas Lauren K Brais Jeffrey A Meyerhardt Michael H Rosenthal Brian M Wolpin Hajime Uno Christina M Dieli-Conwright Resistance exercise combined with protein supplementation for skeletal muscle mass in people with pancreatic cancer undergoing neoadjuvant chemotherapy: Study protocol for the REBUILD trial. PLoS ONE |
| title | Resistance exercise combined with protein supplementation for skeletal muscle mass in people with pancreatic cancer undergoing neoadjuvant chemotherapy: Study protocol for the REBUILD trial. |
| title_full | Resistance exercise combined with protein supplementation for skeletal muscle mass in people with pancreatic cancer undergoing neoadjuvant chemotherapy: Study protocol for the REBUILD trial. |
| title_fullStr | Resistance exercise combined with protein supplementation for skeletal muscle mass in people with pancreatic cancer undergoing neoadjuvant chemotherapy: Study protocol for the REBUILD trial. |
| title_full_unstemmed | Resistance exercise combined with protein supplementation for skeletal muscle mass in people with pancreatic cancer undergoing neoadjuvant chemotherapy: Study protocol for the REBUILD trial. |
| title_short | Resistance exercise combined with protein supplementation for skeletal muscle mass in people with pancreatic cancer undergoing neoadjuvant chemotherapy: Study protocol for the REBUILD trial. |
| title_sort | resistance exercise combined with protein supplementation for skeletal muscle mass in people with pancreatic cancer undergoing neoadjuvant chemotherapy study protocol for the rebuild trial |
| url | https://doi.org/10.1371/journal.pone.0322192 |
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