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NCT02123511 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study, sponsored by Mayo Clinic.

Completed
Registry status
Phase 2
Development phase
34
Enrollment target

NCT02123511: Completed Phase 2 study, sponsored by Mayo Clinic.

NCT02123511 is a Phase 2 study that has completed, run by Mayo Clinic. The registered enrollment target is 34 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT02123511, a Phase 2 study, has completed, sponsored by Mayo Clinic.

COMPLETED
Registry status
Phase 2
Development phase
34 participants
Enrollment target

Study 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.

Primary Outcome

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 assessme

Interventions

  • OTHER placebo
  • OTHER questionnaire administration
  • OTHER quality-of-life assessment
  • DRUG acetylcysteine

Trial Details

FieldValue
Enrollment Target 34 participants
Start Date 2014-04
Est. Completion 2018-07-02
Phase Phase 2
Mayo Clinic

2,844 total trials

What the finished NCT02123511 record still lists

NCT02123511 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower).

The record links to 0 conditions, and to 4 interventions - of which placebo is the first listed.

NCT02123511 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02123511 about?

NCT02123511 is a clinical study titled "Acetylcysteine Rinse in Reducing Saliva Thickness and Mucositis in Patients With Head and Neck Cancer Undergoing Radiation Therapy". 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, ...

What is the current status of trial NCT02123511?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 34 participants. The study started on 2014-04. Estimated completion is 2018-07-02.

What interventions are being tested in trial NCT02123511?

The interventions under investigation include: placebo (OTHER), questionnaire administration (OTHER), quality-of-life assessment (OTHER), acetylcysteine (DRUG).

Who is sponsoring clinical trial NCT02123511?

This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02123511's enrollment target sits among peer trials

34 1539th of 2000 higher than 448 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02123511, the US trial registry maintained by the National Library of Medicine. NCT02123511 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.