Effect of N-Acetyl Cysteine (NAC) on the Oral Microbiome

• Status: Withdrawn
• Trial end date: 2023-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase II treatment, randomized 3:1 ratio, open label clinical trial to study the effect of short duration administration of N-acetyl cysteine on oral microbiome and on mucositis caused by concurrent chemotherapy and radiotherapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wake Forest University Health Sciences
• Collaborator: National Cancer Institute (NCI)
• Treatments: Acetylcysteine; N-monoacetylcystine

Criteria

Inclusion Criteria:

• Patients must have histologically or cytologically confirmed HNSCC.

• Patients must be scheduled for definitive or adjuvant concurrent drug therapy and radiotherapy to include the oral cavity in the field and have a window of at least 14 days between the treatment decision and beginning of treatment.

• Patients must be ≥ 18 years old.

• Willing to provide consent for collection of samples of blood and saliva as scheduled through the treatment.

• Subject is willing and able to comply with the protocol for the duration of the study.

• Ability to understand and the willingness to sign an IRB-approved informed consent document.

Exclusion Criteria:

• Patients who have used NAC as a supplement or as a treatment within the last 6 months.

• Patients who have participated in another clinical study with an investigational product during the last 8 weeks.

• Receipt of anti-cancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies, other investigational agent) within the last 8 weeks.

• Patients who are unable to swallow pills.

• Patients Patient is on medications that need to be continued and that might interact with NAC.

• Uncontrolled pre-existent illness of the digestive tract such as PUD, GERD.

• Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results