Acetylcysteine Rinse in Reducing Saliva Thickness and Mucositis in Patients With Head and Neck Cancer Undergoing Radiation Therapy
A Randomized, Double-Blind Pilot Study of N-Acetylcysteine Mucoadherent Rinse Versus Placebo for Thickened Secretions and Mucositis Secondary to Chemoradiotherapy in the Management of Head and Neck Malignancies
4 other identifiers
interventional
34
1 country
5
Brief Summary
This randomized pilot clinical trial studies whether acetylcysteine oral rinse will lessen saliva thickness and painful mouth sores in patients with head and neck cancer undergoing radiation therapy. Side effects from radiation therapy to the head and neck, such as thickened saliva and mouth sores, may interfere with activities of daily living such as eating and drinking, and may also cause treatment to be stopped or delayed. Acetylcysteine rinse may reduce saliva thickness and mouth sores, and improve quality of life in patients with head and neck cancer undergoing radiation therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Apr 2014
Typical duration for phase_2
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 23, 2014
CompletedFirst Posted
Study publicly available on registry
April 25, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 22, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 2, 2018
CompletedResults Posted
Study results publicly available
April 5, 2019
CompletedApril 30, 2019
December 1, 2018
2 years
April 23, 2014
December 17, 2018
April 22, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Groningen Radiotherapy-Induced Xerostomia (GRIX) Sticky Saliva Total Score Area Under the Curve (AUC)
Groningen Radiotherapy-Induced Xerostomia (GRIX) sticky saliva total score Area under the curve (AUC).The GRIX questionnaire is a 14-item questionnaire with four subscales on 0-100 scales with higher scores representing worse symptoms. The aAUCpa for each subscale is calculated as the average of each AUC between each sequential assessment from treatment-initiation to the end of radiotherapy. For example; for each patient and each subscale, the subscale values at treatment-initiation and assessment-1 are used to calculate an Area Under the Curve (AUC) for that assessment time-period. Then these AUCs for all available assessment time-periods up to the end of their radiotherapy are averaged to yield the aAUCpa per patient per subscale. AUC will be calculated for each patient from baseline to two weeks following radiotherapy. The AUC values will be compared between the two arms using t-test (equal variance).
Up to 2 weeks following radiotherapy
Secondary Outcomes (9)
Groningen Radiotherapy-Induced Xerostomia (GRIX) Sticky Saliva Daytime Area Under the Curve (AUC)
Up to 90 days after completion of radiation therapy
Groningen Radiotherapy-Induced Xerostomia (GRIX) Sticky Saliva Nighttime Area Under the Curve (AUC).
Up to 90 days after completion of radiation therapy
GRIX Xerostomia Daytime AUC
Up to 90 days after completion of radiation therapy
GRIX Xerostomia Nighttime AUC
Up to 90 days after completion of radiation therapy
GRIX Xerostiomia Total Score AUC
Up to 90 days after completion of radiation therapy
- +4 more secondary outcomes
Study Arms (2)
Arm I (acetylcysteine)
EXPERIMENTALPatients receive acetylcysteine oral rinse and gargle or swish for 60 seconds then spit 5 times per day beginning within 3 days of the initiation of radiotherapy to 14 days following completion of radiotherapy.
Arm II (placebo)
PLACEBO COMPARATORPatients receive a placebo oral rinse and gargle or swish for 60 seconds and then spit 5 times per day beginning within 3 days of the initiation of radiotherapy to 14 days following completion of radiotherapy.
Interventions
Oral rinse
Ancillary studies
Eligibility Criteria
You may qualify if:
- Histological confirmation of tumor of the oral cavity, oropharynx, supraglottic larynx, or nasopharynx
- Receiving concurrent chemoradiotherapy/chemobiotherapy to a minimum dose equivalent to 60 Gy in 30 fractions in the adjuvant or definitive setting
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
- Initiation of investigational agent =\< 3 days after initiation of radiotherapy
- Negative pregnancy test done =\< 7 days prior to registration, for women of childbearing potential only
- Ability to complete questionnaire(s) by themselves or with assistance
- Provide informed written consent
- Willing to return mail-in questionnaires during the observation phase of the study
You may not qualify if:
- Any of the following:
- Pregnant women
- Nursing women
- Men or women of childbearing potential who are unwilling to employ adequate contraception
- Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
- Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy; NOTE: patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
- History of myocardial infarction =\< 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
- Receipt of induction chemotherapy
- Previous receipt of head and neck irradiation
- Utilization of amifostine during radiotherapy
- Greater than or equal to grade 2 dry mouth prior to chemoradiotherapy or greater than or equal to grade 2 mucositis
- Previous intolerance/adverse effect/allergy to any component of the placebo or active agent
- History of Sjogren's, lupus or scleroderma
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
- National Cancer Institute (NCI)collaborator
Study Sites (5)
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
State University of New York Upstate Medical University
Syracuse, New York, 13210, United States
Bismarck Cancer Center
Bismarck, North Dakota, 58501, United States
Altru Cancer Center
Grand Forks, North Dakota, 58201, United States
Related Publications (1)
Sio TT, Blanchard MJ, Novotny PJ, Patel SH, Rwigema JM, Pederson LD, McGee LA, Gamez ME, Seeger GR, Martenson JA, Grover Y, Neben Wittich MA, Garces YI, Foote RL, Miller RC, Halyard MY. N-Acetylcysteine Rinse for Thick Secretion and Mucositis of Head and Neck Chemoradiotherapy (Alliance MC13C2): A Double-Blind Randomized Clinical Trial. Mayo Clin Proc. 2019 Sep;94(9):1814-1824. doi: 10.1016/j.mayocp.2019.03.031. Epub 2019 Aug 9.
PMID: 31405750DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Michele Halyard, M.D.; Robert Foote, M.D.
- Organization
- Mayo Clinic
Study Officials
- PRINCIPAL INVESTIGATOR
Michele Halyard
Mayo Clinic
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 23, 2014
First Posted
April 25, 2014
Study Start
April 1, 2014
Primary Completion
March 22, 2016
Study Completion
July 2, 2018
Last Updated
April 30, 2019
Results First Posted
April 5, 2019
Record last verified: 2018-12