Nav: Home

BU: Obese patients underrepresented in cancer clinical trials

April 25, 2018

Obesity is a risk factor for a number of cancer types and can influence cancer treatment outcomes. In 2014, cancer types associated with being overweight or obese represented about 40 percent of all cancers diagnosed in the United States.

But a new review by Boston University School of Public Health (BUSPH) researchers found that less than one-fifth of participants in cancer-related clinical trials are obese.

The study was published in Annals of Oncology.

"Randomized trials are essential to assess the efficacy and safety of new cancer treatments," says senior author Ludovic Trinquart, assistant professor of biostatistics at BUSPH. "However, randomized trials may lack representation of the true clinical populations that will receive the treatment."

Between 2013 and 2014, 35 percent of men and 40 percent of women fell under the BMI "obese" category; since then, the global prevalence of obesity has increased dramatically. Obesity may be associated with an increased risk of progression, recurrence, and death for specific cancer types.

"If obese people are poorly represented, cancer randomized controlled trials (RCTs) may fail to provide adequate information to judge the effect of treatments and dosing in real world settings," the authors wrote. "Our objective was to assess the reporting of information about eligibility and enrollment of obese participants in obesity-related cancer RCTs."

The researchers reviewed 76 clinical trials between the years of 2013 and 2016. For each trial, they assessed the proportion of obese participants, if the eligibility criteria limited the enrollment of obese participants, and whether an analysis according to obesity status was conducted. The researchers also contacted the authors of the trials and asked for more information about the eligibility of obese participants and the proportion of obese participants.

From data obtained from 22 trials, the researchers determined the median proportion of obese participants to be just 18 percent. While obesity was not listed as an exclusion criterion for any of the trials, whether obese participants were eligible to participate or not was unclear in 93 percent of trials. The researchers also found that 95 percent of trials did not initially report on the proportion of obese participants enrolled.

The authors cautioned that underrepresentation of obese patients in obesity-related cancer randomized controlled trials may affect generalizability of results and treatment outcomes.

"The lack of information regarding enrollment of obese participants stands in sharp contrast with the expanding real-world concern of obesity in cancer and ongoing reflections about improving the assessment drugs' safety and efficacy in patients who will ultimately receive them," they wrote. "Given the role of obesity in shaping cancer risks and outcomes, our results highlight the critical need to improve the reporting of obesity status information."

BUSPH alumna Ella Pestine, now a senior research assistant at Harvard Pilgrim Health Care Institute, was lead author on the study. Andrew Stokes, assistant professor of global health at BUSPH, was co-author.
-end-
About Boston University School of Public Health:

Boston University School of Public Health, founded in 1976, offers master's- and doctoral-level education in public health. The faculty in six departments (biostatistics; community health sciences; environmental health; epidemiology; global health; and health law, policy & management) conduct policy-changing public health research around the world, with the mission of improving the health of populations--especially the disadvantaged, underserved, and vulnerable--locally, nationally, and internationally.

Boston University School of Medicine

Related Obesity Articles:

How much do obesity and addictions overlap?
A large analysis of personality studies has found that people with obesity behave somewhat like people with addictions to alcohol or drugs.
Should obesity be recognized as a disease?
With obesity now affecting almost a third (29%) of the population in England, and expected to rise to 35% by 2030, should we now recognize it as a disease?
Is obesity associated with risk of pediatric MS?
A single-center study of 453 children in Germany with multiple sclerosis (MS) investigated the association of obesity with pediatric MS risk and with the response of first-line therapy in children with MS.
Women with obesity prior to conception are more likely to have children with obesity
A systematic review and meta-analysis identified significantly increased odds of child obesity when mothers have obesity before conception, according to a study published June 11, 2019 in the open-access journal PLOS Medicine by Nicola Heslehurst of Newcastle University in the UK, and colleagues.
Obesity medicine association announces major updates to its adult obesity algorithm
The Obesity Medicine Association (OMA) announced the immediate availability of the 2019 OMA Adult Obesity Algorithm, with new information for clinicians including the relationship between Obesity and Cardiovascular Disease, Diabetes Mellitus, Dyslipidemia, and Cancer; information on investigational Anti-Obesity Pharmacotherapy; treatments for Lipodystrophy; and Pharmacokinetics and Obesity.
Systematic review shows risk of a child developing overweight or obesity is more than trebled by maternal obesity prior to pregnancy
New research presented at this year's European Congress on Obesity (ECO) in Glasgow, Scotland (April 28- May 1) reveals that the risk of a child becoming overweight or obese is more than trebled by maternal obesity prior to getting pregnant.
Eating later in the day may be associated with obesity
Eating later in the day may contribute to weight gain, according to a new study to be presented Saturday at ENDO 2019, the Endocrine Society's annual meeting in New Orleans, La.
How obesity affects vitamin D metabolism
A new Journal of Bone and Mineral Research study confirms that vitamin D supplementation is less effective in the presence of obesity, and it uncovers a biological mechanism to explain this observation.
Wired for obesity
In a multi-center collaboration, scientists at Children's Hospital Los Angeles and University of Cambridge discover a set of genes that help to establish brain connections governing body weight.
Sarcopenic obesity: The ignored phenotype
A new condition, that occurs in the presence of both sarcopenia and obesity and termed as ''sarcopenic obesity'', and that describes under the same phenotype the increase in body fat mass deposition, and the reduction in lean mass and muscle strength.
More Obesity News and Obesity Current Events

Top Science Podcasts

We have hand picked the top science podcasts of 2019.
Now Playing: TED Radio Hour

Risk
Why do we revere risk-takers, even when their actions terrify us? Why are some better at taking risks than others? This hour, TED speakers explore the alluring, dangerous, and calculated sides of risk. Guests include professional rock climber Alex Honnold, economist Mariana Mazzucato, psychology researcher Kashfia Rahman, structural engineer and bridge designer Ian Firth, and risk intelligence expert Dylan Evans.
Now Playing: Science for the People

#540 Specialize? Or Generalize?
Ever been called a "jack of all trades, master of none"? The world loves to elevate specialists, people who drill deep into a single topic. Those people are great. But there's a place for generalists too, argues David Epstein. Jacks of all trades are often more successful than specialists. And he's got science to back it up. We talk with Epstein about his latest book, "Range: Why Generalists Triumph in a Specialized World".
Now Playing: Radiolab

Dolly Parton's America: Neon Moss
Today on Radiolab, we're bringing you the fourth episode of Jad's special series, Dolly Parton's America. In this episode, Jad goes back up the mountain to visit Dolly's actual Tennessee mountain home, where she tells stories about her first trips out of the holler. Back on the mountaintop, standing under the rain by the Little Pigeon River, the trip triggers memories of Jad's first visit to his father's childhood home, and opens the gateway to dizzying stories of music and migration. Support Radiolab today at Radiolab.org/donate.