Charcoal in Lung Cancer Patients Undergoing TEMLA

Masonic Cancer Center, University of Minnesota

Overview

This proof-of-concept study serves as the preliminary step to prove safety of oral activated charcoal (OAC) in patients with solid tumors before moving to a hematologic malignancy patient population.

TEMLA (Transcervical Extended Mediastinal Lymphadenectomy) is a procedure for mediastinal lymph node sampling to stage patients with lung cancer. All patients receive a dose of IV antibiotic pre-procedure to prevent infection. The concept of the proposed study is to protect the gut microbiome against detrimental effects of the antibiotic using oral activated charcoal as a potent adsorbent with no absorption. Oral activated charcoal (OAC) binds to the fraction of IV antibiotic that reaches the lumen of the gut without interfering with its desired systemic effects. The conceptual goal is to prevent dysbiosis by protecting the gut microbiome. Dysbiosis is the leading cause of C. difficile infection and a number of other adverse clinical outcomes such as antibiotic resistance.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Conditions

Lung Cancer

Interventions

Activated charcoalDRUG

Activated Charcoal, Powder, USP is carbon that has been treated to create low-volume pores that increase the area available for chemical reactions and adsorption. The most common pharmaceutical uses of activated charcoal is as a purification agent and antitoxin. All Spectrum Chemical USP products are manufactured, packaged and stored under current Good Manufacturing Practices (cGMP) per 21CFR part 211 in FDA registered and inspected facilities.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Suspected or confirmed diagnosis of lung cancer (non-small cell lung cancer, small-cell lung cancer or neuroendocrine tumor) for which a standard of care Transcervical Extended Mediastinal Lymphadenectomy (TEMLA) is planned * Planned pre-procedural IV antibiotic. The choice of antibiotic type is up to the treatment physician(s) * Able to safely hold all oral medications on the day of surgery and the day after to ensure the absorption of such drugs is not affected due to charcoal ingestion the night before surgery * 18 years of age or older * Able to provide written consent prior to any research related activities Exclusion Criteria: * Current pregnancy or breastfeeding (SOC pre-TEMLA testing/assessment) * Any current diagnosed disease with known involvement of the gastrointestinal tract * Known allergy to oral activated charcoal * CTCAE v 5 Dysphagia Grade 2 (symptomatic and altered eating/swallowing) or greater * Known risk of aspiration based on history or current complaints * Gastrointestinal procedures within 2 weeks before or (planned) after TEMLA * Systemic antibiotic use within 8 weeks before planned TEMLA

Outcomes

Primary Outcomes

Number of patients who are free from analgesics within 3 days of TEMLA

The duration of analgesic medication use after a standard of care Transcervical Extended Mediastinal Lymphadenectomy (TEMLA) is observed and the number of patients who are free from analgesics is reported

Time frame: 3 days after surgery

Secondary Outcomes

Number of patients experiencing gastrointestinal adverse events

Incidence of gastrointestinal AEs (nausea, vomiting, abdominal pain, bloating) within 5 days after ingesting charcoal

Time frame: 5 days after surgery

Number of patients with C. difficile infection

Incidence of C. difficile infection within 4 weeks after TEMLA

Time frame: 4 weeks after surgery

Characterization of changes in microbiome diversity

Stool microbiome diversity will be determined by 16S rRNA gene sequencing of samples. Analyses will include alpha and beta diversity, descriptive microbiota composition at the genus level, and comparing these indices between pre- and post- samples.

Time frame: pre-surgery and through study completion, 21-35 days after surgery

Characterization of changes in microbiome composition

Stool microbiome composition will be determined by 16S rRNA gene sequencing of samples.

Time frame: pre-surgery and through study completion , 21-35 days after surgery

Data from ClinicalTrials.gov

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