Charcoal in Lung Cancer Patients Undergoing TEMLA

Safety of Oral Activated Charcoal and Its Effect on the Gut Microbiome In Patients With Lung Cancer Undergoing Transcervical Extended Mediastinal Lymphadenectomy (TEMLA)

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.

Study Overview

• Status: Withdrawn
• Conditions: Lung Cancer
• Intervention / Treatment: Drug: Activated charcoal

Detailed Description

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
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Adults undergoing TEMLA; Adults undergoing TEMLA (Transcervical Extended Mediastinal Lymphadenectomy) take Oral Activated Charcoal (OAC) dissolved in apple juice a night before the surgery

Drug: Activated charcoal; 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.; Other Names: Medical grade AC, "Activated Charcoal Powder, USP", activated carbon

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients experiencing gastrointestinal adverse events	Incidence of gastrointestinal AEs (nausea, vomiting, abdominal pain, bloating) within 5 days after ingesting charcoal	5 days after surgery
Number of patients with C. difficile infection	Incidence of C. difficile infection within 4 weeks after TEMLA	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.	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.	pre-surgery and through study completion , 21-35 days after surgery

Collaborators and Investigators

• Sponsor: Masonic Cancer Center, University of Minnesota
• Investigators: Principal Investigator: Armin J Rashidi, MD, PhD, Masonic Cancer Center, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2022
• Primary Completion (Anticipated): January 1, 2025
• Study Completion (Anticipated): January 1, 2025

Study Registration Dates

• First Submitted: June 4, 2021
• First Submitted That Met QC Criteria: June 9, 2021
• First Posted (Actual): June 16, 2021

Study Record Updates

• Last Update Posted (Actual): February 9, 2022
• Last Update Submitted That Met QC Criteria: January 26, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Lung cancer; Gut microbiome; Activated charcoal; TEMLA
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Physiological Effects of Drugs; Protective Agents; Antidotes; Charcoal
• Other Study ID Numbers: 2021LS022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No