Efficacy of nutritional supplement on efficacy of immunotherapy in lung cancer
Conditions
Interventions
Patients will start with 2 times daily nutritional intervention preferably 5
days (with a minum of 3 days) prior to start the first infusion of
immunotherapy, and remain on treatment and nutritional
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Participants are eligible to be included in the study if the following criteria apply: • Age > 18 years • Patient must be willing and capable of giving written Informed Consent, and meeting all study requirements • Capable of oral intake and digestion of the nutritional test product • Subjects with cytologically confirmed Stage IV or recurrent NSCLC, who have not received prior systemic therapy treatment for their advanced NSCLC. Completion of treatment with cytotoxic chemotherapy, biological therapy, and/or radiation as part of neoadjuvant/adjuvant therapy is allowed as long as therapy was completed at least 6 months prior to the diagnosis of metastatic disease.
Exclusion criteria
Exclusion criteria: • Subject with an active auto-immune disease requiring systemic treatment • Lung disease requiring systemic steroids in doses of >10 mg prednisolone (or equivalent dose of other steroid) • Previous allogeneic or organ transplant • Serious concomitant systemic disorders (for example active infection, unstable cardiovascular disease) which in the opinion of the investigator would compromise the patient's ability to complete the study, or would interfere with the evaluation of the efficacy and safety of the study treatment • Known positive test for hepatitis B virus or hepatitis C virus or human immunodeficiency virus (HIV) indicating acute or chronic infection • Allergy to cow*s milk protein, soy or fish, requiring a fibre-free diet or suffering galactosemia or lactose intolerance • Moderate to severe hypercalcemia, i.e. total calcium level corrected for albumin >=142.0 mg/dL (3.05 mmol/L ) • Patient has had other malignancies within the past 3 years , except for stable non-melanoma skin cancer, fully treated and stable early stage prostate cancer or carcinoma in situ of the cervix or breast without need of treatment • Simultaneous participation in other clinical trial • Pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main endpoint is the recruitment rate: how many patients can be recruited in 1 year? Secundary endpoints are the rate of compliance to the study procedures including the intake of the nutritional intervention and the rate of data collection (blood samples, fecal samples, diaries). In order to study feasibility of an nutritional intervention study in NSCLC patients receiving anti PDL-1 treatment, the primary objective is to assess whether it is possible to recruit 50 patients in 1.5 year for this study. The secondary objective is to assess whether it is feasible for the subjects to comply with the study protocol (i.e. undergo study assessments and collect blood and faecal samples at the indicated time points). Lastly, exploratory objectives are to study the effect of the nutritional intervention on anti-PD-1 drug clearance, immune activation status, nutritional status, microbiome status, and clinical response. | — |
Countries
Netherlands
Outcome results
None listed