Nutrition assessment reports in oncology clinical trials.

Authors

null

Ye Myint Aung

Department of Supportive Oncology, Levine Cancer Institute, Atrium Health, Charlotte, NC

Ye Myint Aung , Aynur Aktas , Vishal Shroff , Kunal C. Kadakia , Jake Waldman , Declan Walsh

Organizations

Department of Supportive Oncology, Levine Cancer Institute, Atrium Health, Charlotte, NC, Department of Internal Medicine at Atrium Health Carolinas Medical Center, Charlotte, NC, Department of Solid Tumor Oncology and Supportive Oncology, Levine Cancer Institute, Atrium Health, Charlotte, NC

Research Funding

No funding received
None.

Background: Malnutrition is common in cancer and associated with greater treatment toxicity and poor clinical outcomes. Validated screening tools can identify individuals at risk; however, they are underutilized in clinical practice. It is also unclear how nutrition status is assessed and reported in oncology clinical trials. We analyzed nutrition assessment protocols in clinical trials published in major US oncology journals. Methods: Three researchers (YA, AA, VS) identified studies published in the Journal of Clinical Oncology, JAMA Oncology, and the New England Journal of Medicine under the “original reports”, “original articles”, or “’ research” categories, respectively (1/1/2022-12/31/2022). We selected studies that reported outcomes of systemic therapeutic interventions in any Phase clinical trial. This included chemotherapy, hormone therapy, and immunotherapy alone or combined with radiation therapy or surgical procedures. Systematic reviews, meta-analyses, commentaries, retrospective studies, and secondary analyses of pooled data from completed trials were excluded. Descriptive statistics summarized how malnutrition risk was assessed and nutrition data reported. Results: 521 articles were reviewed; 153 (29%) studies met eligibility criteria. Most were randomized trials (103/153, 67%) and Phase II or III (126/153, 82%). Malnutrition risk assessment was absent from all studies. Overall, 15/153 (10%) reported either baseline Body Mass Index or pre-treatment weight changes. These variables were included in the survival analysis of 5/15 studies. The primary cancer sites studied were breast (5/15), gynecologic (3/15), hematologic (3/15), multiple sites (2/15), prostate (1/15), and pancreatic (1/15). Conclusions: Most oncology clinical trials ignore and/or underreport nutrition status. Only 10% of the studies reported nutrition status data, and not all cancer sites were represented. There is a need to routinely assess nutrition status and (given the major prognostic value) investigate its potential uses for patient selection and stratification in clinical trials.

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Abstract Details

Meeting

2023 ASCO Annual Meeting

Session Type

Publication Only

Session Title

Publication Only: Symptoms and Survivorship

Track

Symptom Science and Palliative Care

Sub Track

Palliative Care and Symptom Management

Citation

J Clin Oncol 41, 2023 (suppl 16; abstr e24142)

DOI

10.1200/JCO.2023.41.16_suppl.e24142

Abstract #

e24142

Abstract Disclosures