At some point during treatment, an estimated 70% of lung cancer patients will experience malnourishment, which can negatively affect quality of life, reduce the efficacy of treatment, and lead to worse outcomes. The ongoing NutriCare study, which just finished phase II accrual, tests an evidence-based nutrition intervention to see if food can effectively improve patients’ nutrition status, reduce treatment-related toxicities, and improve their quality of life.
Investigator Carolyn Presley, MD, MPH, an Associate Professor in the Division of Medical Oncology/Department of Internal Medicine at the Ohio State University Comprehensive Cancer Center and the James Cancer Hospital/Solove Research Institute, recently spoke with ILCN about the study and about the importance of food as medicine, particularly in the era of immunotherapy.
Participants in the NutriCare study were randomized to either the intervention—or NutriCare—arm or the enhanced control—or NutriTool—arm. Patients in the intervention arm receive meals and snacks delivered to their homes as well as regular one-on-one counseling with a registered dietitian. Patients in the enhanced control arm receive a nutrition toolkit with printed education materials, but do not receive meals or nutrition counseling.
To be included in the study, patients had to have increased risk for malnourishment or food insecurity. This includes patients who are:
- economically disadvantaged (at or below 130% of the US federal poverty level);
- members of a racial and ethnic minority population;
- age 65 years old or older;
- residing in rural areas (counties with fewer than 50,000 people); or
- without health insurance.
ILCN: The NutriCare study has multiple goals. For those unfamiliar with the project, tell us a little about why you are studying food as a medical intervention?
Dr. Presley: The nice thing about nutrition is that it is something patients and families have control over. I think it is one of the best untapped, modifiable interventions we have to help patients and families. Families want to do things to help; this is one of those areas where we can provide education and recommendations, and they can have control over it.
Our study really focuses on our most vulnerable patients; those who may not have access to nutritious food. We know highly processed foods are not good for you, so how do you get fresh food to people who lack transportation because they’re older or in a rural area? How do you ensure people on fixed incomes have enough food?
ILCN: In December, you presented some of the phase I data from the NutriCare study? What are some of the highlights from that initial data?
Dr. Presley: In our phase I, we randomized 127 patients who met one of our vulnerability criteria and the majority had non-small cell histology, as you would expect. Yet more than half were older than 65 years of age, which is more reflective of what I would consider the non-clinical trial patient population. About 20% were low income, about 30% resided in rural areas, about 16% were from a racial or ethnic minority group, and 14% had no health insurance. Additionally, more than 70% had stage III or IV disease. So this was a really diverse representation.
We found that diet quality as measured by the Healthy Eating Index significantly improved in the NutriCare group. We delivered more than 10,000 meals and snacks and provided one-on-one counseling with a dietitian on a regular basis for patients in the NutriCare group. We believe it was a combination of the food, the motivational interviewing, and the counseling with the dietitian that led to this significant Improvement.
We also found—and again, this is just in our first 127 patients—that though we didn’t decrease the number of hospital visits, we were able to decrease the length of hospitalizations. These are patients with lung cancer, the majority with stage III or IV. We know these patients are going to be in and out of the hospital. We know they have a lot of symptoms that could be due to disease progression or side effects. If we can shave 2 days off those hospitalizations, that’s great. If we can get them home sooner, that’s what we want to do.
ILCN: In addition to the quantitative data you are collecting, I know you have also been collecting a lot of qualitative data as well. What is that data telling you about how access to healthful food impacts a patient’s quality of life?
Dr. Presley: Using the EORTC QLQ-C30 (the European Organization for the Research and Treatment of Cancer Quality of Life Group Core Questionnaire), when we look at that total score, the change was non-significant. But it was much higher at 3 and 8 months in the NutriCare group compared to the NutriTool group, though quality of life scores did improve in both groups. That could be, in part, because they were getting cancer treatment, and they were starting to feel better.
The sub-scores of the quality-of-life metrics are particularly interesting. Even though the overall score didn’t change significantly, we did see significant improvements in areas such as appetite and emotional functioning. That could be attributable to the nutrition counseling and meals. We are also seeing Improvement in insomnia and fatigue in the NutriCare group versus the enhanced control. These are bothersome symptoms, so if we can make them better, that’s great.
ILCN: Looking at food as medicine in general, we know diet plays a role in the microbiome, and we also know the microbiome influences immune response and the efficacy of immunotherapy treatment. What do we know about how food could potentially be used to improve response and/or outcomes for patients receiving immunotherapy?
Dr. Presley: Yes, we know that there is an immune relationship with the microbiome, particularly in the gut. And we know there are things that we can do to potentially help our treatments work better. Diet could have a direct treatment effect.
So this is a really hot area of ongoing research right now. How do you either change the diet or supplement the diet? We hear a lot about probiotics, but they can be difficult to use as supplements because of the variability in their purity. However, we do think a diet high in fiber really feeds the good organisms in the gut, and it also helps reduce constipation and diarrhea. Should we be recommending diets high in fiber? And what type of fiber should we be giving? Certain amino acid supplements may also help to enrich certain types of bacteria.
These are all things that we are actively working on because we know that not only is the microbiome different from person to person, it changes with age. We also know the immune system changes with age, and that really affects how our immune checkpoint inhibitors work.
We are working in collaboration with our translational science colleagues to try to understand which good bacteria we should be trying to enrich and how to do that in a safe way, either through diet or a supplement—whether that’s a nutraceutical or an amino acid. What building blocks do these good bacteria need?
And then you throw in antibiotic use or proton pump inhibitor use, which we know disrupts the microbiome. We know that these medications can harm the bacteria that we want and can allow overgrowth of bacteria that we don’t want. How many patients with lung cancer get multiple rounds of antibiotics before they’re finally diagnosed because what was initially thought to be an infection is actually cancer.? They’re almost set up for failure.
ILCN: What else should those in the lung cancer community—clinicians and patients alike—know about the importance of food in cancer care?
The No. 1 thing is sugar does not cause cancer. That is the No. 1 takeaway.
I also really discourage patients from going on restrictive diets while they’re going through cancer treatment. One of my main messages to my patients is don’t lose weight during this time. Weight loss is a bad prognostic sign, and many times when patients come in, they have already lost a significant amount of weight, so going on fad diets is not going to be helpful. I really want them to maintain or even increase their weight—particularly if it leads to more muscle mass.
I encourage patients to eat small, frequent meals, particularly if they’re losing weight. Small, frequent meals and snacking can help to increase the total number of calories one consumes. If you stop eating, it often makes symptoms like nausea and upset stomach worse.
We want patients to build muscle mass and exercise, and that I think is the next study—combining a nutritional intervention with increased physical activity. This is something that we are working on because it’s counterintuitive. Patients are tired and think they should rest, but the opposite—activity—can really help cancer-related fatigue.
