Patients with bronchial and oesophageal/gastric carcinoma with indication for immunotherapy
Conditions
Interventions
Group 1: 60 patients with histologically confirmed EGA or lung adenocarcinoma with indication for immunotherapy.
Sponsors
Universitätsklinikum Hamburg Eppendorf (UKE)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Histologically confirmed EGA or lung adenocarcinoma with indication for immunotherapy or immunochemotherapy. - The participant gives his/her written consent for the study. - The participant is at least 18 years old on the day of signing the consent form. - No prior systemic anticancer therapy for (metastatic) disease (e.g. cytotoxic or targeted agents). - ECOG (Eastern Cooperative Oncology Group) performance status score of = 2.
Exclusion criteria
Exclusion criteria: - Major surgery within 2 weeks of the start of the study intervention or patients who have not fully recovered from the effects of previous surgery. - Malnutrition risk: weight loss of more than 10% of body weight in the last 6 weeks, NRS score > 3, a BMI < 18.5, an albumin value < 20 mg/dl or if 50% of daily energy is provided by enteral/parenteral nutrition. - Short bowel syndrome, enterostomy. - Previous intestinal obstruction or risk of intestinal obstruction. - Participants:in with diagnosed immunodeficiency or those receiving chronic systemic steroid therapy (at a dosage greater than 10 mg daily prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug. - Participants:in with an active infection requiring systemic therapy. - Participants:in with a known history of human immunodeficiency virus (HIV) or hepatitis infection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Achievement of an average dietary fibre intake of 25 g per day of the intervention in at least 70% of patients with lung or oesophago-gastric adenocarcinoma | — |
Secondary
| Measure | Time frame |
|---|---|
| - Determination of the subgroups that particularly benefit from the nutritional intervention to be tested (parameters: therapy response, overall survival, progression-free survival). For this purpose, patient-specific parameters such as age and gender, tumour-specific parameters such as metastasis site and histology as well as clinical parameters such as blood count and inflammation markers are used. - Examination of the effectiveness of the intervention depending on the level of fibre intake. - Comparison of the survival of the overall cohort with historical cohorts in terms of overall response rate, progression-free survival and overall survival. - Measurement of the increase in short-chain fatty acids (SCFAs) in the patients' faeces and serum on day 0 and day 4 of each cycle. - Investigation of the direct effect of SCFAs and other microbiota-derived metabolites such as 3-IAA on the formation of antitumour immune responses and on therapy response using preclinical models. | — |
Countries
Germany
Contacts
Public ContactMarianne Sinn Hamburg
UCC Hamburg- Universitäres Cancer Centrum Hamburg
Outcome results
None listed