Clinical Trial: Acetylcysteine Rinse in Reducing Saliva Thickness and Mucositis in Patients With Head and Neck Cancer Undergoing Radiation Therapy

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: 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 Ma

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 Summary:

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 beginn
Sponsor: Mayo Clinic

Current Primary Outcome: Area under the curve (AUC) of the GRIX sticky saliva total score [ Time Frame: Up to 2 weeks following radiotherapy ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Scores for sticky saliva during the day, assessed using the GRIX subscale [ Time Frame: Up to 90 days after completion of radiation therapy ]
  AUCs will be compared using either t-tests (equal variance or unequal variance) or Wilcoxon nonparametric tests. Linear regression and repeated measures analyses will be done to adjust for confounding factors. Mean scores and 95% confidence intervals will be plotted over time by arm.
• Scores for sticky saliva during the night, assessed using the GRIX subscale [ Time Frame: Up to 90 days after completion of radiation therapy ]
  AUCs will be compared using either t-tests (equal variance or unequal variance) or Wilcoxon nonparametric tests. Linear regression and repeated measures analyses will be done to adjust for confounding factors. Mean scores and 95% confidence intervals will be plotted over time by arm.
• Scores for xerostomia during the day, assessed using the GRIX subscale [ Time Frame: Up to 90 days after completion of radiation therapy ]
  AUCs will be compared using either t-tests (equal variance or unequal variance) or Wilcoxon nonparametric tests. Linear regression and repeated measures analyses will be done to adjust for confounding factors. Mean scores and 95% confidence intervals will be plotted over time by arm.
• Scores for xerostomia during the night, assessed using the GRIX subscale [ Time Frame: Up to 90 days after completion of radiation therapy ]
  AUCs will be compared using either t-tests (equal variance or unequal variance) or Wilcoxon nonparametric tests. Linear regression and repeated measures analyses will be done to adjust for confounding factors. Mean scores and 95% confidence intervals will be plotted over time by arm.
• Xerostomia total scores, assessed using the GRIX subscale [ Time Frame: Up to 90 days after completion of radiation therapy ]
  AUCs will be compared using either t-tests (equal variance or unequal variance) or Wilcoxon nonparametric tests. Linear regression and repeated measures analyses will be done to adjust for confounding factors. Mean scores and 95% confidence intervals will be plotted over time by arm.
• QLQ-H&N35 scores [ Time Frame: Up to 90 days after completion of radiation therapy ]
  Scores will be compared between the two arms
• Adverse event profile of NAC [ Time Frame: Up to 90 days after completion of radiation therapy ]
  The adverse event profile of NAC will be summarized by looking at the incidence and maximum severity of each adverse event.

Original Secondary Outcome:

• Scores for sticky saliva during the day, assessed using the GRIX subscale [ Time Frame: Up to 90 days after completion of radiation therapy ]
  AUCs will be compared using either t-tests (equal variance or unequal variance) or Wilcoxon nonparametric tests. Linear regression and repeated measures analyses will be done to adjust for confounding factors. Mean scores and 95% confidence intervals will be plotted over time by arm.
• Scores for sticky saliva during the night, assessed using the GRIX subscale [ Time Frame: Up to 90 days after completion of radiation therapy ]
  AUCs will be compared using either t-tests (equal variance or unequal variance) or Wilcoxon nonparametric tests. Linear regression and repeated measures analyses will be done to adjust for confounding factors. Mean scores and 95% confidence intervals will be plotted over time by arm.
• Scores for xerostomia during the day, assessed using the GRIX subscale [ Time Frame: Up to 90 days after completion of radiation therapy ]
  AUCs will be compared using either t-tests (equal variance or unequal variance) or Wilcoxon nonparametric tests. Linear regression and repeated measures analyses will be done to adjust for confounding factors. Mean scores and 95% confidence intervals will be plotted over time by arm.
• Scores for xerostomia during the night, assessed using the GRIX subscale [ Time Frame: Up to 90 days after completion of radiation therapy ]
  AUCs will be compared using either t-tests (equal variance or unequal variance) or Wilcoxon nonparametric tests. Linear regression and repeated measures analyses will be done to adjust for confounding factors. Mean scores and 95% confidence intervals will be plotted over time by arm.
• Xerostomia total scores, assessed using the GRIX subscale [ Time Frame: Up to 90 days after completion of radiation therapy ]
  AUCs will be compared using either t-tests (equal variance or unequal variance) or Wilcoxon nonparametric tests. Linear regression and repeated measures analyses will be done to adjust for confounding factors. Mean scores and 95% confidence intervals will be plotted over time by arm.
• QLQ-H&N35 scores [ Time Frame: Up to 90 days after completion of radiation therapy ]
  Scores will be compared between the two arms

Dates:
Date Received: April 23, 2014
Date Started: April 2014
Date Completion: April 2018
Last Updated: March 21, 2017
Last Verified: March 2017