Clinical trial NCT02123511
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
Sponsor: Mayo Clinic
Start date: 2014-04-01; Completion date: 2018-07-02
Enrollment: 34 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

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.

Detailed description:
PRIMARY OBJECTIVES:

I. To determine the effectiveness of N-acetylcysteine (acetylcysteine) in improving saliva viscosity (as measured by the Groningen Radiotherapy-Induced Xerostomia \[GRIX\]) in patients undergoing chemotherapy and radiotherapy for head and neck cancer.

SECONDARY OBJECTIVES:

I. To determine whether N-acetylcysteine (NAC) can improve other GRIX subscale for patients undergoing chemotherapy and radiotherapy for head and neck cancer.

II. To determine whether NAC can improve patient reported quality of life as measured by the European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire (QLQ) Head \& Neck (H\&N)35.

III. To assess the adverse event profile of NAC as measured by the Common Terminology Criteria for Adverse Events (CTCAE) every week during radiation.

IV. To determine patient adherence to N-acetylcysteine mucoadherent rinse using patient reported surveys.

V. To determine the long-term benefits of N-acetylcysteine as measured by the GRIX questionnaire at 45 days and 90 days post treatment.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients 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: Patients 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.

After completion of study treatment, patients are followed up at 45 and 90 days.

Arms: arm 1: Patients 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 2: Patients 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: intervention 1: acetylcysteine intervention 2: placebo intervention 3: quality-of-life assessment intervention 4: questionnaire administration
Intervention descriptions: intervention 1: Oral rinse intervention 2: Oral rinse intervention 3: Ancillary studies intervention 4: Ancillary studies

Protocol documents: