Radiotherapy With Humidification in Head And Neck Cancer

NCT01917942 | Completed Phase 3 DMC

• 1 other identifier: TROG 07.03
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

This is a two arm randomised phase III trial which will evaluate prospectively the benefits of humidification in patients receiving radiotherapy / chemoradiation for head and neck cancer. The intent of humidification is to moisturise the mucosa. The rationale for the use of humidification with radiotherapy can be considered an extension of the general principle of moist wound care in wound management.

Conditions

Cancer of the Head and Neck

Keywords

Radiotherapy; Humidification; Mucositis

Outcome Measures

Primary Outcomes (1)

• Intensity of mucositis as a function of time for CTCAE grade > 1 mucositis (e.g. grade 2 or higher) measured as the area under the time curve (AUC) of the plot expressing grade of acute reactions vs weeks for observed CTCAE mucosal reactions > 1.

  week 12

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR

Standard of Care

Other: Standard of Care

Humidification

EXPERIMENTAL

Humidification

Device: Humidification

Interventions

Humidification DEVICE

Fisher and Paykel Healthcare MR880 humidifier + HC211 flow source. 37/44 Humidification (37oC at 100% relative humidity, 44 mg of water per litre of air, 25 litres per min initial flow rate). The patients will be instructed to use humidification from day 1 of the radiotherapy course as much as is practical; the preference is for continuous overnight humidification plus maximal use throughout the day.Humidification will continue throughout treatment until at least week 8 after the commencement of radiotherapy and will cease when the CTCAE mucositis (clinical exam) score becomes less than grade 2, or at the week 16 assessment, whichever is earliest.

Humidification

Standard of Care OTHER

SOC: institutional standard of care for the management of mucositis. SOC will be defined by each participating institution and be kept consistent at that institution for the duration of the study. In general, SOC will consist of rinsing with 50:50 salt bicarbonate of soda mouthwash; benzydamine mouthwash; appropriate analgesic, antimicrobial and antifungal protocols etc.

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who meet the following criteria will be eligible:
• Pathologically confirmed diagnosis of cancer involving the Nasopharynx, Oropharynx, Oral Cavity, Larynx, or Hypopharynx
• Regional nodal irradiation included in PTV1 (as a minimum ipsilateral levels II-III)
• Prescribed dose of radiotherapy is at least 60 Gy
• Receiving definitive or post-operative adjuvant Radiotherapy
• Receiving Radiotherapy as sole modality or Chemoradiation
• Patient \> 18 years old
• Available for follow-up for up to 2 years
• Life expectancy greater than 6 months
• Written informed consent
• Participation of patients on other clinical trial protocols permitted

You may not qualify if:

• Patients who meet the following criteria will be excluded:
• Presence of tracheostomy or stoma
• Diagnosis of T1 / T2 glottic carcinoma
• Undergoing CPAP therapy -Treatment with Amifostine or Palifermin (keratinocyte growth factor) during radiotherapy
• History of previous radiotherapy to the head and neck region, excluding superficial radiotherapy to cutaneous squamous cell carcinoma or basal cell carcinoma
• High risk for poor compliance with radiotherapy, humidification, or follow-up as assessed by the investigator

Sponsors & Collaborators

• Trans Tasman Radiation Oncology Group: lead
• Auckland City Hospital: collaborator
• Fisher and Paykel Healthcare: collaborator

Study Sites (1)

Auckland Hospital

Auckland, 1001, New Zealand

Location

Related Links

• Click here for more information about this study on the TROG official website

MeSH Terms

Conditions

Head and Neck Neoplasms; Mucositis

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Andrew Macann

  Auckland Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2013
• First Posted: August 7, 2013
• Study Start: June 1, 2008
• Primary Completion: November 1, 2011
• Study Completion: August 1, 2013
• Last Updated: July 12, 2017

Record last verified: 2017-07

Locations

NZ (1)