Phase 2
N=34
Acetylcysteine Rinse in Reducing Saliva Thickness and Mucositis in Patients With Head and Neck Cancer Undergoing Radiation Therapy
Mucositis · Oral Complications · Recurrent Adenoid Cystic Carcinoma of the Oral Cavity · Recurrent Basal Cell Carcinoma of the Lip · Recurrent Lymphoepithelioma of the Nasopharynx
Bottom Line
View on ClinicalTrials.gov: NCT02123511 ↗Enrolled (actual)
34
Serious AEs
15.2%
Results posted
Apr 2019
Primary outcome: Primary: Groningen Radiotherapy-Induced Xerostomia (GRIX) Sticky Saliva Total Score Area Under the Curve (AUC) — 40.9; 27.2 score on a scale — p=0.1232
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- acetylcysteine (Drug); placebo (Other); quality-of-life assessment (Other); questionnaire administration (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Mar 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Groningen Radiotherapy-Induced Xerostomia (GRIX) Sticky Saliva Total Score Area Under the Curve (AUC) |
40.9; 27.2 | 0.1232 |
| SECONDARY Groningen Radiotherapy-Induced Xerostomia (GRIX) Sticky Saliva Daytime Area Under the Curve (AUC) |
45.2; 26.1 | 0.0422 sig |
| SECONDARY Groningen Radiotherapy-Induced Xerostomia (GRIX) Sticky Saliva Nighttime Area Under the Curve (AUC). |
34.5; 29.1 | 0.5634 |
| SECONDARY GRIX Xerostomia Daytime AUC |
44.1; 27.3 | 0.02 sig |
| SECONDARY GRIX Xerostomia Nighttime AUC |
39.8; 31.3 | 0.22 |
| SECONDARY GRIX Xerostiomia Total Score AUC |
43.8; 28.5 | 0.02 sig |
| SECONDARY EORTC Quality of Life Questionnaire (QLQ) H&N Pain AUC |
32.4; 32.0 | 0.95 |
| SECONDARY EORTC Quality of Life Questionnaire (QLQ) Swallowing |
34.7; 22.3 | 0.17 |
| SECONDARY EORTC Quality of Life Questionnaire (QLQ) H&N Sticky Saliva AUC |
46.3; 37.9 | 0.48 |
| SECONDARY Adverse Event, as Measured by the Number of Patients With a Maximum Grade of Any Adverse Event |
0; 1; 2; 0; 3; 5 | 0.3824 |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02123511). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.