Clinical trial · Interventional
Effect of N-Acetyl Cysteine (NAC) on the Oral Microbiome
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Concept is withdrawn and a different concept will be submitted the near future.
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemotherapy and Radiation | Radiation | — | UNRESOLVED |
| N-Acetyl-L-Cysteine dietary supplement | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Nature's Blend N-Acetyl-L-Cysteine 600 mg with Chemotherapy
- description
- 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).
- interventionNames
- Drug: N-Acetyl-L-Cysteine dietary supplement
- Radiation: Chemotherapy and Radiation
- type
- OTHER
- label
- Standard of Care Chemotherapy (CONTROL)
- description
- Patients will receive definitive or adjuvant concurrent chemotherapy and radiotherapy as per standard of care
- interventionNames
- Radiation: Chemotherapy and Radiation
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
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