Charcoal in Lung Cancer Patients Undergoing TEMLA

Phase 2

Withdrawn

• Conditions: Lung Cancer
• Interventions: Drug: Activated charcoal

• Registration Number: NCT04928950
• Lead Sponsor: Masonic Cancer Center, University of Minnesota

Brief Summary

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.

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 Timeline

• Study First Submitted: 2021-06-04
• Study First Submitted QC: 2021-06-09
• Study First Posted: 2021-06-16
• Status Verified: 2022-01
• Study Start: 2022-01-26
• Last Update Submitted: 2022-01-26
• Last Update Posted: 2022-02-09
• Primary Completion: 2025-01
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Adults undergoing TEMLA	Activated charcoal	Adults undergoing TEMLA (Transcervical Extended Mediastinal Lymphadenectomy) take Oral Activated Charcoal (OAC) dissolved in apple juice a night before the surgery

Primary Outcome Measures

Name	Time	Method
Number of patients who are free from analgesics within 3 days of TEMLA	3 days after surgery	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

Secondary Outcome Measures

Name	Time	Method
Number of patients with C. difficile infection	4 weeks after surgery	Incidence of C. difficile infection within 4 weeks after TEMLA
Characterization of changes in microbiome composition	pre-surgery and through study completion , 21-35 days after surgery	Stool microbiome composition will be determined by 16S rRNA gene sequencing of samples.
Number of patients experiencing gastrointestinal adverse events	5 days after surgery	Incidence of gastrointestinal AEs (nausea, vomiting, abdominal pain, bloating) within 5 days after ingesting charcoal
Characterization of changes in microbiome diversity	pre-surgery and through study completion, 21-35 days after surgery	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.