Pilot Study of Pulmozyme (rhDNase) in Patients With Head and Neck Cancers Treated With Radiation Therapy + Chemotherapy
RATIONALE: Nebulized dornase alfa inhalation solution may decrease the thickness of saliva in the mouth and improve quality of life in patients undergoing radiation therapy and chemotherapy for head and neck cancer. It is not yet known whether dornase alfa inhalation solution is more effective than a placebo in lessening the discomfort of treatment in these patients.
PURPOSE: This randomized clinical trial is studying how well dornase alfa inhalation solution works compared with a placebo in treating patients with stage III or stage IV head and neck cancer undergoing radiation therapy and chemotherapy.
Head and Neck Cancer
Radiation: Radiation Therapy
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
|Official Title:||A Pilot Study of Pulmozyme (rhDNase) in Patients With Head and Neck Cancers Treated With Radiation and Chemotherapy|
- Treatment-related symptoms as assessed daily by the Head and Neck Symptom Inventory Scale (MD Anderson Symptom Inventory) [ Time Frame: 5 times per week during study treatment and once per month up to 3 months post-treatment ] [ Designated as safety issue: No ]
- Quality of life as assessed weekly by the Functional Assessment of Cancer Therapy - Head & Neck Neck questionnaire [ Time Frame: Weekly during study treatment and once per month up to 3 months post-treatment. ] [ Designated as safety issue: No ]
- Patient comfort and/or disturbance during radiotherapy treatment as assessed daily by Radiation Treatment Disturbance Disturbance Measures questionnaire [ Time Frame: Daily during radiation treatment ] [ Designated as safety issue: No ]
- Reduction in amount of thick oropharyngeal secretions associated with cancer therapy. [ Time Frame: At baseline, prior to radiation and study treatment, and after radiation. ] [ Designated as safety issue: No ]
- Incidence of mucositis, infections, and aspiration pneumonia [ Time Frame: Weekly during study treatment. ] [ Designated as safety issue: Yes ]
|Study Start Date:||February 2008|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||October 2014 (Final data collection date for primary outcome measure)|
Experimental: Arm 1
Pulmozyme 2.5 mL ampules (2.5 mg) will be nebulized and inhaled once daily using a recommended nebulizer
Other Name: dornase alfa inhalation solutionRadiation: Radiation Therapy
5 days per week for 4 weeks
Placebo Comparator: Arm 2
Placebo 2.5 mL ampules (2.5 mg) will be nebulized and inhaled once daily using a recommended nebulizerRadiation: Radiation Therapy
5 days per week for 4 weeks
- To determine if use of nebulized dornase alfa inhalation solution can improve the overall daily symptom and quality of life as well as reduce treatment discomfort during radiotherapy and chemotherapy in patients with stage III or IV squamous cell carcinoma of the head and neck.
- To determine if once daily nebulized dornase alfa inhalation solution given prior to radiotherapy can reduce thick oropharyngeal secretions associated with curative radiotherapy and chemotherapy in these patients.
- To determine if reduction in thick oropharyngeal secretions with the use of nebulized dornase alfa inhalation solution can decrease the incidence of mucositis, infections, and aspiration pneumonia.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive nebulized dornase alfa inhalation solution via oral inhalation approximately 30 minutes prior to radiation therapy on days 1-5. Treatment continues for up to 4 weeks (weeks 3-6 of radiation therapy) in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive nebulized placebo via oral inhalation approximately 30 minutes prior to radiation therapy on days 1-5. Treatment continues for up to 4 weeks as in arm I.
All patients are assessed for treatment-related symptoms and treatment disturbance daily during radiation therapy. Patients are assessed for quality of life weekly during radiation therapy and then monthly during follow-up for 3 months. Clinical symptoms (i.e., mucositis, bacterial and fungal infections, and aspiration pneumonia) are also assessed weekly during radiation therapy.
Sputum samples are collected prior to initiating radiation therapy (at baseline) and periodically during week 3 of radiation treatment and evaluated for salivary DNA levels.
After completion of study therapy, patients are followed monthly for 3 months and then every 3-4 months for a minimum of 2 years.
|United States, Illinois|
|Robert H. Lurie Comprehensive Cancer Center at Northwestern University|
|Chicago, Illinois, United States, 60611-3013|
|Study Chair:||Bharat B. Mittal, MD||Robert H. Lurie Cancer Center|