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Withdrawn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
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
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
NCT ID
NCT04928950
First Posted
June 4, 2021
Last Updated
January 26, 2022
Sponsor
Masonic Cancer Center, University of Minnesota
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
Learn more about this trial
Charcoal in Lung Cancer Patients Undergoing TEMLA
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