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Charcoal in Lung Cancer Patients Undergoing TEMLA

Primary Purpose

Lung Cancer

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Activated charcoal
Sponsored by
Masonic Cancer Center, University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Lung Cancer focused on measuring Lung cancer, Activated charcoal, Gut microbiome, TEMLA

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Adults undergoing TEMLA

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Number of patients experiencing gastrointestinal adverse events
    Incidence of gastrointestinal AEs (nausea, vomiting, abdominal pain, bloating) within 5 days after ingesting charcoal
    Number of patients with C. difficile infection
    Incidence of C. difficile infection within 4 weeks after TEMLA
    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.
    Characterization of changes in microbiome composition
    Stool microbiome composition will be determined by 16S rRNA gene sequencing of samples.

    Full Information

    First Posted
    June 4, 2021
    Last Updated
    January 26, 2022
    Sponsor
    Masonic Cancer Center, University of Minnesota
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04928950
    Brief Title
    Charcoal in Lung Cancer Patients Undergoing TEMLA
    Official Title
    Safety of Oral Activated Charcoal and Its Effect on the Gut Microbiome In Patients With Lung Cancer Undergoing Transcervical Extended Mediastinal Lymphadenectomy (TEMLA)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2022
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Because of logistic challenges and lack of product among other factors, we decided to completely withdrawn this study.
    Study Start Date
    January 26, 2022 (Actual)
    Primary Completion Date
    January 2025 (Anticipated)
    Study Completion Date
    January 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Masonic Cancer Center, University of Minnesota

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lung Cancer
    Keywords
    Lung cancer, Activated charcoal, Gut microbiome, TEMLA

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Model Description
    15 adults undergoing TEMLA enrolled in a 12-month period.
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Adults undergoing TEMLA
    Arm Type
    Experimental
    Arm Description
    Adults undergoing TEMLA (Transcervical Extended Mediastinal Lymphadenectomy) take Oral Activated Charcoal (OAC) dissolved in apple juice a night before the surgery
    Intervention Type
    Drug
    Intervention Name(s)
    Activated charcoal
    Other Intervention Name(s)
    Medical grade AC, "Activated Charcoal Powder, USP", activated carbon
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Number of patients who are free from analgesics within 3 days of TEMLA
    Description
    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 Outcome Measure Information:
    Title
    Number of patients experiencing gastrointestinal adverse events
    Description
    Incidence of gastrointestinal AEs (nausea, vomiting, abdominal pain, bloating) within 5 days after ingesting charcoal
    Time Frame
    5 days after surgery
    Title
    Number of patients with C. difficile infection
    Description
    Incidence of C. difficile infection within 4 weeks after TEMLA
    Time Frame
    4 weeks after surgery
    Title
    Characterization of changes in microbiome diversity
    Description
    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
    Title
    Characterization of changes in microbiome composition
    Description
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Armin J Rashidi, MD, PhD
    Organizational Affiliation
    Masonic Cancer Center, University of Minnesota
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Charcoal in Lung Cancer Patients Undergoing TEMLA

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