Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06323135 |
| Other study ID # |
2019-725 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 17, 2019 |
| Est. completion date |
September 11, 2023 |
Study information
| Verified date |
March 2024 |
| Source |
West China Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The goal of this retrospective observational study is to evaluate the prognostic value of
nutrition assessment tool in advanced cancers. We aim to evaluate the clinical utility of
nutrition assessment tool in predicting the clinical outcomes of cancer patients, which would
help the clinicians to make tailored decision for this population.
Description:
To date, cancer is the leading cause of disability and death globally. Cancer-related
mortality rate differs significantly across the world, reflecting varying patterns of
inherent genetic heterogeneity and medical resources available factors. Considerable
proportions of patients remained diagnosed with advanced-stage cancers at the initial visit,
given the differences between demographic geographical and socioeconomic regions, and
inadequate resources of China. For this reason, how to make adequate clinical management and
prognostic prediction for advanced-stage cancers are still challenged. Malnutrition is
prevalent in cancer patients, accounting for approximately 20% to 80% of the cancer
population, which plays a key role in the short-and long-term clinical outcomes. Providing
more real-world clinical evidence for supporting the beneficial role of nutritional screening
in advanced-stage cancers can help to improve clinical nursing care for advanced-stage
patients, especially in developing countries.
The malnutrition status of cancer patients is often accompanied by symptoms of poor nutrient
intake, weight loss, progress of systemic inflammatory disorders, and upregulated immune
responses. Emerging evidence has determined that the systemic pro-inflammation status was
positively associated with elevated malnutritional scores and consistently predicted the
worse survival probabilities of cancer patients. Notably, the European Society for Clinical
Nutrition and Metabolism (ESPEN) expert consensus regarding the action against cancer-related
malnutrition recommended that nutritionists were encouraged to use additional biomarkers to
assess the severity of cancer-related systemic inflammation burdens, which might enhance the
predictive value of existing malnutritional screening tools in clinical practice. Although
the PG-SGA criteria, the nutrition assessment tool, has been widely interpreted and validated
to be a simple and easily available tool for the prognosis prediction for varied cancers in
recent years, the criteria of the PG-SGA lacked the calculation of systemic inflammatory
burdens. Whether the inflammatory indicators could be the surrogate biomarkers for enhancing
the prediction ability of PG-SGA for advanced-stage cancer patients remains less studied.
Therefore, we aim to fill the mentioned research gaps to conduct this observational study.
