Acetylcysteine Rinse in Reducing Saliva Thickness and Mucositis in Patients With Head and Neck Cancer Undergoing Radiation Therapy
NCT02123511 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 34
Last updated 2019-04-30
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.
Conditions
- Mucositis
- Oral Complications
- Recurrent Adenoid Cystic Carcinoma of the Oral Cavity
- Recurrent Basal Cell Carcinoma of the Lip
- Recurrent Lymphoepithelioma of the Nasopharynx
- Recurrent Lymphoepithelioma of the Oropharynx
- Recurrent Mucoepidermoid Carcinoma of the Oral Cavity
- Recurrent Salivary Gland Cancer
- Recurrent Squamous Cell Carcinoma of the Larynx
- Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity
- Recurrent Squamous Cell Carcinoma of the Nasopharynx
- Recurrent Squamous Cell Carcinoma of the Oropharynx
- Recurrent Verrucous Carcinoma of the Larynx
- Recurrent Verrucous Carcinoma of the Oral Cavity
- Stage I Adenoid Cystic Carcinoma of the Oral Cavity
- Stage I Basal Cell Carcinoma of the Lip
- Stage I Lymphoepithelioma of the Nasopharynx
- Stage I Lymphoepithelioma of the Oropharynx
- Stage I Mucoepidermoid Carcinoma of the Oral Cavity
- Stage I Salivary Gland Cancer
- Stage I Squamous Cell Carcinoma of the Larynx
- Stage I Squamous Cell Carcinoma of the Lip and Oral Cavity
- Stage I Squamous Cell Carcinoma of the Nasopharynx
- Stage I Squamous Cell Carcinoma of the Oropharynx
- Stage I Verrucous Carcinoma of the Larynx
- Stage I Verrucous Carcinoma of the Oral Cavity
- Stage II Adenoid Cystic Carcinoma of the Oral Cavity
- Stage II Basal Cell Carcinoma of the Lip
- Stage II Lymphoepithelioma of the Nasopharynx
- Stage II Lymphoepithelioma of the Oropharynx
- Stage II Mucoepidermoid Carcinoma of the Oral Cavity
- Stage II Salivary Gland Cancer
- Stage II Squamous Cell Carcinoma of the Larynx
- Stage II Squamous Cell Carcinoma of the Lip and Oral Cavity
- Stage II Squamous Cell Carcinoma of the Nasopharynx
- Stage II Squamous Cell Carcinoma of the Oropharynx
- Stage II Verrucous Carcinoma of the Larynx
- Stage II Verrucous Carcinoma of the Oral Cavity
- Stage III Adenoid Cystic Carcinoma of the Oral Cavity
- Stage III Basal Cell Carcinoma of the Lip
- Stage III Lymphoepithelioma of the Nasopharynx
- Stage III Lymphoepithelioma of the Oropharynx
- Stage III Mucoepidermoid Carcinoma of the Oral Cavity
- Stage III Salivary Gland Cancer
- Stage III Squamous Cell Carcinoma of the Larynx
- Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity
- Stage III Squamous Cell Carcinoma of the Nasopharynx
- Stage III Squamous Cell Carcinoma of the Oropharynx
- Stage III Verrucous Carcinoma of the Larynx
- Stage III Verrucous Carcinoma of the Oral Cavity
- Stage IV Lymphoepithelioma of the Nasopharynx
- Stage IV Squamous Cell Carcinoma of the Nasopharynx
- Stage IVA Adenoid Cystic Carcinoma of the Oral Cavity
- Stage IVA Basal Cell Carcinoma of the Lip
- Stage IVA Lymphoepithelioma of the Oropharynx
- Stage IVA Mucoepidermoid Carcinoma of the Oral Cavity
- Stage IVA Salivary Gland Cancer
- Stage IVA Squamous Cell Carcinoma of the Larynx
- Stage IVA Squamous Cell Carcinoma of the Lip and Oral Cavity
- Stage IVA Squamous Cell Carcinoma of the Oropharynx
- Stage IVA Verrucous Carcinoma of the Larynx
- Stage IVA Verrucous Carcinoma of the Oral Cavity
- Stage IVB Adenoid Cystic Carcinoma of the Oral Cavity
- Stage IVB Basal Cell Carcinoma of the Lip
- Stage IVB Lymphoepithelioma of the Oropharynx
- Stage IVB Mucoepidermoid Carcinoma of the Oral Cavity
- Stage IVB Salivary Gland Cancer
- Stage IVB Squamous Cell Carcinoma of the Larynx
- Stage IVB Squamous Cell Carcinoma of the Lip and Oral Cavity
- Stage IVB Squamous Cell Carcinoma of the Oropharynx
- Stage IVB Verrucous Carcinoma of the Larynx
- Stage IVB Verrucous Carcinoma of the Oral Cavity
- Stage IVC Adenoid Cystic Carcinoma of the Oral Cavity
- Stage IVC Basal Cell Carcinoma of the Lip
- Stage IVC Lymphoepithelioma of the Oropharynx
- Stage IVC Mucoepidermoid Carcinoma of the Oral Cavity
- Stage IVC Salivary Gland Cancer
- Stage IVC Squamous Cell Carcinoma of the Larynx
- Stage IVC Squamous Cell Carcinoma of the Lip and Oral Cavity
- Stage IVC Squamous Cell Carcinoma of the Oropharynx
- Stage IVC Verrucous Carcinoma of the Larynx
- Stage IVC Verrucous Carcinoma of the Oral Cavity
- Tongue Cancer
Interventions
- DRUG
-
acetylcysteine
Oral rinse
- OTHER
-
placebo
Oral rinse
- OTHER
-
quality-of-life assessment
Ancillary studies
- OTHER
-
questionnaire administration
Ancillary studies
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH - lead OTHER
Principal Investigators
-
Michele Halyard · Mayo Clinic
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-04-30
- Primary Completion
- 2016-03-22
- Completion
- 2018-07-02
Countries
- United States
Study Locations
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