Effect of N-Acetyl Cysteine (NAC) on the Oral Microbiome and on the Degree of Mucositis Developed in Response to Concurrent Chemotherapy and Radiotherapy in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck
Trial Snapshot
- Phase
- Phase 2
- Status
- Withdrawn
- Primary Endpoint
- Reduction in Severe Mucositis with Pre-treatment N-acetyl cysteine
Study Overview
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.
Detailed Description
Primary Objective(s) I. To determine whether short duration pre-treatment with N-acetyl cysteine reduces the rate of severe mucositis that develops during the standard concurrent chemoradiotherapy in patients with locally advanced Head and Neck Squamous Cell Cancer.
Secondary Objective(s) I. Identify the effect of N-acetyl cysteine on the oral microbiome.
II. Identify the effect of short duration pre-treatment with N-acetyl cysteine on the duration and delay onset of severe radiation-induced mucositis developed during the standard concurrent chemoradiotherapy in patients with locally advanced Head and Neck Squamous Cell Cancer.
III. Bank saliva and blood for future studies of biomarkers that will be correlated with changes in the oral microbiome and the duration of mucositis.
IV. Determine if there is any effect of short duration pre-treatment with N-acetyl cysteine on tumor response to standard CRT as measured within the first year of treatment.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Nature's Blend N-Acetyl-L-Cysteine 600 mg with Chemotherapy
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).
Intervention: N-Acetyl-L-Cysteine dietary supplement (Drug)
Nature's Blend N-Acetyl-L-Cysteine 600 mg with Chemotherapy
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).
Intervention: Chemotherapy and Radiation (Radiation)
Standard of Care Chemotherapy (CONTROL)
Patients will receive definitive or adjuvant concurrent chemotherapy and radiotherapy as per standard of care
Intervention: Chemotherapy and Radiation (Radiation)
Outcomes
Primary Outcomes
Reduction in Severe Mucositis with Pre-treatment N-acetyl cysteine
Time Frame: 3 months post treatment
Severe mucositis will be defined as Grade III or IV mucositis as per WHO OM classification.
Secondary Outcomes
- Number of Participants with Change in Blood Biomarkers - Standard of Care Chemoradiotherapy(At baseline and one year post treatment)
- Tumor Response(One year post treatment)
- Probability in Structure Changes of Microbiomes in Relation to Human Papillomavirus and Smoking Statuses and N-acetyl cysteine(One year post treatment)
- 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)
- Number of Participants with Change in Saliva Biomarkers - Standard of Care Chemoradiotherapy(At baseline and one year post treatment)
- Number of Participants with Change in Blood Biomarkers - N-acetyl cysteine(At baseline and one year post treatment)