Charcoal in Lung Cancer Patients Undergoing TEMLA

University of Minnesota (UMN)

Status and phase: Withdrawn; Phase 2

Conditions: Lung Cancer

Treatments: Drug: Activated charcoal

Study type: Interventional

Funder types: Other

Identifiers

NCT04928950

2021LS022

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Adults undergoing TEMLA

Experimental group

Description:

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

Treatment:

Drug: Activated charcoal