Study of Personalized Sterile Humidification Device for Mucositis in Head and Neck Cancer Patients

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2014-08-31

Brief Summary

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This is a single arm study of the use of a personalized sterile humidification device for 12 weeks for head and neck cancer patients undergoing radiation therapy to determine if the usage of this humidification system will result in a decrease in severity in head and neck related quality of life as measured by the MDASI HN subscale following radiation therapy as compared with historical experience. In addition, we are exploring correlative measures using CRP, IL-1, IL-6, and TNF-alpha level measurements as these are directly related to mucositis and presumably related to quality of life as indicated by the patient.

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Detailed Description

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The patients complete MDASI at baseline, 6 weeks, and 12 weeks. The MDASI is a validated instrument that measures symptom burden and we measure a subscale (HN) as our primary endpoint. The patients are asked to use a personal humidifier daily and complete a weekly diary showing compliance with the humidifier use.

Conditions

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Head and Neck Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

humidification feasibility and efficacy

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Sterile Humidification Device, MyPurMist

Sterile Humidification Device Twice a day, 15 minutes each 12 weeks

Group Type EXPERIMENTAL

Sterile Humidification Device

Intervention Type DEVICE

This is a personal humidification device. It is hand held and produces sterile warm vapor.

Interventions

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Sterile Humidification Device

This is a personal humidification device. It is hand held and produces sterile warm vapor.

Intervention Type DEVICE

Other Intervention Names

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MyPurMist

Eligibility Criteria

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Inclusion Criteria

* Receiving a dose of radiation therapy greater than or equal to 6000 cGy to one third of the oral cavity.
* Receiving definitive or post-operative adjuvant radiotherapy.
* Receiving radiotherapy or chemoradiation.
* Of age greater than 18 years.
* Life expectancy greater than 6 months.
* Able to provide informed consent.
* Participation of patients on other clinical trial protocols permitted, if not prohibited by trial guidelines.

Exclusion Criteria

* Undergoing induction or neoadjuvant chemotherapy prior to radiotherapy.
* Treatment with amifostine or palifermin (keratinocyte growth factor) during radiotherapy.
* High risk for poor compliance with radiotherapy, humidification, or follow-up as assessed by the investigator.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No