Charcoal in Lung Cancer Patients Undergoing TEMLA

NCT04928950 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: 2021LS022
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Lung Cancer

Keywords

Lung cancer; Activated charcoal; Gut microbiome; TEMLA

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Number of patients experiencing gastrointestinal adverse events

  5 days after surgery

• Number of patients with C. difficile infection

  4 weeks after surgery

• Characterization of changes in microbiome diversity

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

• Characterization of changes in microbiome composition

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

Study Arms (1)

Adults undergoing TEMLA

EXPERIMENTAL

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

Drug: Activated charcoal

Interventions

Activated charcoal DRUG

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.

Also known as: Medical grade AC, "Activated Charcoal Powder, USP", activated carbon

Adults undergoing TEMLA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years of age or older
• Able to provide written consent prior to any research related activities

You may not qualify if:

• 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

Sponsors & Collaborators

• Masonic Cancer Center, University of Minnesota: lead

MeSH Terms

Conditions

Lung Neoplasms; Anthrax

Interventions

Charcoal

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Bacillaceae Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Carbon; Elements; Inorganic Chemicals

Study Officials

• Armin J Rashidi, MD, PhD

  Masonic Cancer Center, University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 15 adults undergoing TEMLA enrolled in a 12-month period.

Study Record Dates

• First Submitted: June 4, 2021
• First Posted: June 16, 2021
• Study Start: January 26, 2022
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: February 9, 2022

Record last verified: 2022-01