Lung CancerPhase 2NCT04928950
Charcoal in Lung Cancer Patients Undergoing TEMLA
A Phase 2 study testing Activated charcoal in people with Lung Cancer, run by Masonic Cancer Center, University of Minnesota.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Activated charcoal
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 26 Jan 2022to Jan 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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)
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.
Read the 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.
- Conditions
- Lung Cancer
- Being tested
- Activated charcoal
- Keywords
- Lung cancer, Activated charcoal, Gut microbiome, TEMLA
- Medical subject headings
- Lung Neoplasms, Anthrax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activated charcoalDrug
Also called Medical grade AC, "Activated Charcoal Powder, USP", activated carbon
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Activated charcoal |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 days after surgery
Secondary outcomes (4)
Number of patients experiencing gastrointestinal adverse events
Incidence of gastrointestinal AEs (nausea, vomiting, abdominal pain, bloating) within 5 days after ingesting charcoal
Measured: 5 days after surgery
Number of patients with C. difficile infection
Incidence of C. difficile infection within 4 weeks after TEMLA
Measured: 4 weeks after surgery
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.
Measured: pre-surgery and through study completion, 21-35 days after surgery
Characterization of changes in microbiome composition
Stool microbiome composition will be determined by 16S rRNA gene sequencing of samples.
Measured: pre-surgery and through study completion , 21-35 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2021
- Study start26 Jan 2022
- Primary completionJan 2025 (estimated)
- Study completionJan 2025 (estimated)
Why it stopped: Because of logistic challenges and lack of product among other factors, we decided to completely withdrawn this study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Masonic Cancer Center, University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 15 adults undergoing TEMLA enrolled in a 12-month period.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Armin J Rashidi, MD, PhD, Principal investigator, Masonic Cancer Center, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04928950
- Sponsor's protocol ID
- 2021LS022
- Status last verified
- Jan 2022
- First submitted
- 4 Jun 2021
- Last updated
- 9 Feb 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04928950
- Acronym / sponsor ID
- 2021LS022
- Conditions
- Lung Cancer
- Keywords
- Lung cancer, Activated charcoal, Gut microbiome, TEMLA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Because of logistic challenges and lack of product among other factors, we decided to completely withdrawn this study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Study start
- 26 Jan 2022 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 16 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 15 adults undergoing TEMLA enrolled in a 12-month period.
| Arm | Type | Receives |
|---|---|---|
| Adults undergoing TEMLA | Experimental | Drug: Activated charcoalAdults undergoing TEMLA (Transcervical Extended Mediastinal Lymphadenectomy) take Oral Activated Charcoal (OAC) dissolved in apple juice a night before the surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Activated charcoalAlso: Medical grade AC, "Activated Charcoal Powder, USP", activated carbonActivated 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. | Drug | Adults undergoing TEMLA |
Primary outcome
Number of patients who are free from analgesics within 3 days of TEMLA
Time frame: 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
4 secondary outcomes
Number of patients experiencing gastrointestinal adverse events
Time frame: 5 days after surgery
Number of patients with C. difficile infection
Time frame: 4 weeks after surgery
Characterization of changes in microbiome diversity
Time frame: pre-surgery and through study completion, 21-35 days after surgery
Characterization of changes in microbiome composition
Time frame: pre-surgery and through study completion , 21-35 days after surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Armin J Rashidi, MD, PhD principal investigator
Masonic Cancer Center, University of Minnesota
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Activated charcoal in people with Lung Cancer, run by Masonic Cancer Center, University of Minnesota.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients who are free from analgesics within 3 days of TEMLA (time frame: 3 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2022.