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Malnutrition, Physical Inactivity Negatively Affect Cancer Care and Outcomes
PHILADELPHIA (November 22, 2019) – A number of patients involved in clinical trials for drugs being developed to treat cancer may be malnourished and sedentary, a factor that may result in inaccurate results for the trials, according to a new study from researchers at Fox Chase Cancer Center.
“We found that patients who were malnourished had higher rates of side effects from therapy, hospitalizations, lower response rates, and a shortened survival. While we suspected that patients with malnutrition may have worse outcomes, the magnitude of this effect was alarming,” said Rishi Jain, MD, MS, DABOM, an assistant professor in the Department of Hematology/Oncology at Fox Chase, and a member of the Cancer Prevention and Control Program.
Jain has an MS in nutrition and is board certified in obesity medicine; his primary research focuses on the intersections between nutrition and cancer. He conducted the research with colleagues from the Fox Chase Biostatistics and Bioinformatics Facility and the Department of Clinical Genetics.
Previous research has shown that malnutrition and physical inactivity are common in patients with advanced cancer and are also associated with poor treatment outcomes. In addition, data from various studies have shown that changes in body composition due to malnutrition affect how cancer drugs move into, through, and out of the body, something that may affect clinical trials.
The researchers sought to understand the relationships between baseline nutrition and exercise status with trial endpoints such as toxicity and survival. Baseline assessments of nutrition and exercise status were conducted in patients prior to initiation of Phase I and II oncology clinical trials. One hundred patients were recruited, 87 of whom were beginning a Phase I trial. Sixty percent were beginning trials studying immunotherapeutic agents.
“We found that 39 percent of patients enrolling in a Phase I or II clinical trial were severely malnourished at the time of study initiation. We also found that 52 percent of patients were sedentary, with minimal physical activity,” Jain said. “There was around a two-fold increased risk of hospitalizations and severe side effects in those who were malnourished. Also, patients who were malnourished were only able to stay on the clinical trial study for half as long.”
Jain added that the findings contribute to the growing literature showing that compromised nutritional status and physical performance negatively affect cancer care and outcomes. Given how important Phase I and II clinical trials are to the identification of future cancer therapies, there is an urgent need to understand the specific reasons why malnutrition may interfere with the effectiveness of these novel treatments, including immunotherapies, Jain said.
He and his colleagues are now conducting research to better understand how dietary habits change during cancer treatment to identify ways to prevent malnutrition in patients with advanced cancer. They are also exploring enhanced screening efforts to identify malnutrition early and intervene aggressively. Lastly, they are also looking into the relationship between nutritional status and other related measures such as changes in taste, muscle loss, and quality of life.
The study, “Impact of Baseline Nutrition and Exercise Status on Toxicity and Outcomes in Phase I and II Oncology Clinical Trial Participants,” was published in The Oncologist.
Fox Chase Cancer Center (Fox Chase), which includes the Institute for Cancer Research and the American Oncologic Hospital and is a part of Temple Health, is one of the leading comprehensive cancer centers in the United States. Founded in 1904 in Philadelphia as one of the nation’s first cancer hospitals, Fox Chase was also among the first institutions to be designated a National Cancer Institute Comprehensive Cancer Center in 1974. Fox Chase is also one of just 10 members of the Alliance of Dedicated Cancer Centers. Fox Chase researchers have won the highest awards in their fields, including two Nobel Prizes. Fox Chase physicians are also routinely recognized in national rankings, and the Center’s nursing program has received the Magnet recognition for excellence five consecutive times. Today, Fox Chase conducts a broad array of nationally competitive basic, translational, and clinical research, with special programs in cancer prevention, detection, survivorship, and community outreach. It is the policy of Fox Chase Cancer Center that there shall be no exclusion from, or participation in, and no one denied the benefits of, the delivery of quality medical care on the basis of race, ethnicity, religion, sexual orientation, gender, gender identity/expression, disability, age, ancestry, color, national origin, physical ability, level of education, or source of payment.
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