Clinical trial NCT04928950: 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
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Lung Cancer
Keywords: Lung cancer
Activated charcoal
Gut microbiome
TEMLA
Lead sponsor: Masonic Cancer Center, University of Minnesota
Sponsor class: OTHER
First posted: 2021-06-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 15 adults undergoing TEMLA enrolled in a 12-month period.
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Number of patients who are free from analgesics within 3 days of TEMLA
timeFrame: 3 days after surgery
Secondary outcomes:
measure: Number of patients experiencing gastrointestinal adverse events
timeFrame: 5 days after surgery
measure: Number of patients with C. difficile infection
timeFrame: 4 weeks after surgery
measure: Characterization of changes in microbiome diversity
timeFrame: pre-surgery and through study completion, 21-35 days after surgery
measure: Characterization of changes in microbiome composition
timeFrame: pre-surgery and through study completion , 21-35 days after surgery
Other outcomes:
Locations:
Study officials:
affiliation: Masonic Cancer Center, University of Minnesota
name: Armin J Rashidi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: