NCT03982537|WithdrawnPhase 2DMCFDA Drug
Study Stopped
Concept is withdrawn and a different concept will be submitted the near future.
Loading search results
Concept is withdrawn and a different concept will be submitted the near future.
Sponsor study identifier
Secondary identifiers
OTHER · Wake Forest Baptist Comprehensive Cancer Center
NIH
interventional
0
0 countries
N/A
Study Start
June 18, 2020
Actual (reported)Primary Completion
June 18, 2020
Actual (reported)Study Completion
June 18, 2020
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 18, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 5, 2019
Actual (reported)June 11, 2019
Actual (reported)June 18, 2020
Actual (reported)June 18, 2020
Actual (reported)June 18, 2020
Actual (reported)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
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
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).
Patients will receive definitive or adjuvant concurrent chemotherapy and radiotherapy as per standard of care
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.
Mercedes Porosnicu, MD
Wake Forest University Health Sciences
0 participants (actual enrollment reported by the registry).
First Submitted
June 5, 2019
First Posted
June 11, 2019
Study Start
June 18, 2020
Actual (reported)Primary Completion
S9715, Chemotherapy and Radiation Therapy in Treating Patients With Advanced Cancer of the Nasopharynx
Participants will receive definitive or adjuvant concurrent chemotherapy and radiotherapy s per standard of care.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
June 18, 2020
Actual (reported)Study Completion
June 18, 2020
Actual (reported)Last Updated
December 19, 2022
Record last verified: 2022-12
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: