The Effects of an Nutritional Intervention on PD-1 ICI in NSCLC
Status:
Recruiting
Trial end date:
2024-01-01
Target enrollment:
Participant gender:
Summary
Over 65% of all lung cancer patients experience significant weight loss fuelled by a
catabolic state that is represented by enhanced protein breakdown. The metabolic state of
patients is a key effector of protein clearance, and the increased albumin as well as
monoclonal antibodies clearance that is observed in patients with progressive cancer disease
inversely correlates with treatment response and may well be consequential to changes in the
metabolic state of cancer patients. Interestingly, several studies in cancer patients
receiving chemotherapy, amongst which are NSCLC patients, have shown that weight loss and
catabolism can be prevented or improved by intake of high energy/high protein Oral
Nutritional Supplements (ONS). An increased clearance of anti-PD-1 ICI may also represent a
general dysfunctioning of the immune system, because immune cell activation, proliferation,
migration and tumor cell killing may all be influenced by cachexia. Enrichment of nutritional
supplements with specific nutrients known to have immune-modulating properties, may further
balance immune responses supportive of ICI efficacy.
The investigators hypothesize that high energy/high protein nutritional supplements decrease
protein clearance including drug clearance in NSCLC patients receiving anti-PD-1 ICIs, which
on its turn would positively affect anti-PD-1 drug bioavailability, leading to activation of
the immune system and thereby an increased response to PD-1 ICIs.
The primary aim is to investigate the variability of clearance during a 12-weeks nutritional
intervention period. The secondary aim is to investigate the feasibility for the subjects to
comply with the study protocol. Lastly, the investigators aim to study the feasibility of
gathering data on a number of exploratory parameters that may link nutritional intake to
clinically relevant outcomes.