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

NCT03982537 | Withdrawn Phase 2 DMC FDA Drug

• 3 other identifiers: IRB00058729WFBCCC 97119P30CA012197
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Head and Neck Cancer

Keywords

Head and neck squamous cell cancer

Outcome Measures

Primary Outcomes (1)

• Reduction in Severe Mucositis with Pre-treatment N-acetyl cysteine

  Severe mucositis will be defined as Grade III or IV mucositis as per WHO OM classification.

  3 months post treatment

Secondary Outcomes (10)

• Effects of N-acetyl cysteine on oral microbiome

  At baseline and one year post treatment

• Effects of standard of care chemoradiotherapy on oral microbiome

  At baseline and one year post treatment

• Number of Incidences of Severe Mucositis on N-acetyl cysteine

  One year post treatment

• Number of Incidences of Severe Mucositis with Standard of Care Chemoradiotherapy

  One year post treatment

• Number of Participants with Change in Saliva Biomarkers - N-acetyl cysteine

  At baseline and one year post treatment

Study Arms (2)

Nature's Blend N-Acetyl-L-Cysteine 600 mg with Chemotherapy

EXPERIMENTAL

The treatment with NAC will be given twice daily for at least 10 days with the goal to cover the window of opportunity time between the treatment decision for CRT and the beginning of treatment (usually 14-21 days).

Drug: N-Acetyl-L-Cysteine dietary supplement; Radiation: Chemotherapy and Radiation

Standard of Care Chemotherapy (CONTROL)

OTHER

Patients will receive definitive or adjuvant concurrent chemotherapy and radiotherapy as per standard of care

Radiation: Chemotherapy and Radiation

Interventions

N-Acetyl-L-Cysteine dietary supplement DRUG

Treatment will be administered on an outpatient basis, either twice daily or 48 hours prior to starting chemotherapy radiation. Eligible participants will start NAC at least 9 days before definitive or adjuvant radiation therapy.

Also known as: N-Acetyl-L-Cysteine

Nature's Blend N-Acetyl-L-Cysteine 600 mg with Chemotherapy

Chemotherapy and Radiation RADIATION

Participants will receive definitive or adjuvant concurrent chemotherapy and radiotherapy s per standard of care.

Nature's Blend N-Acetyl-L-Cysteine 600 mg with Chemotherapy; Standard of Care Chemotherapy (CONTROL)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Acetylcysteine; Drug Therapy; Radiation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Therapeutics; Physical Phenomena

Study Officials

• Mercedes Porosnicu, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2019
• First Posted: June 11, 2019
• Study Start: June 18, 2020
• Primary Completion: June 18, 2020
• Study Completion: June 18, 2020
• Last Updated: December 19, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share