Overview

This trial is active, not recruiting.

Condition head and neck cancer
Treatments pulmozyme, placebo, radiation therapy
Phase phase 0
Sponsor Northwestern University
Collaborator Genentech
Start date February 2008
End date October 2014
Trial size 36 participants
Trial identifier NCT00536952, GENENTECH-NU-06N2, NU 06N2, STU00001045

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose supportive care
Arm
(Experimental)
Pulmozyme
pulmozyme dornase alfa inhalation solution
Pulmozyme 2.5 mL ampules (2.5 mg) will be nebulized and inhaled once daily using a recommended nebulizer
radiation therapy
5 days per week for 4 weeks
(Placebo Comparator)
Placebo
placebo
Placebo 2.5 mL ampules (2.5 mg) will be nebulized and inhaled once daily using a recommended nebulizer
radiation therapy
5 days per week for 4 weeks

Primary Outcomes

Measure
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
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.
Patient comfort and/or disturbance during radiotherapy treatment as assessed daily by Radiation Treatment Disturbance Disturbance Measures questionnaire
time frame: Daily during radiation treatment

Secondary Outcomes

Measure
Reduction in amount of thick oropharyngeal secretions associated with cancer therapy.
time frame: At baseline, prior to radiation and study treatment, and after radiation.
Incidence of mucositis, infections, and aspiration pneumonia
time frame: Weekly during study treatment.

Eligibility Criteria

Male or female participants at least 18 years old.

DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed squamous cell carcinoma of the oral cavity, nasopharynx, oropharynx, hypopharynx, or larynx - Stage III or IV disease - Confirmation from primary site and/or lymph nodes - Patients with a history of head and neck cancer allowed provided they have not received prior radiotherapy - Prior localized radiotherapy for skin cancer arising in the head and neck region is allowed - Planning to receive radiation therapy and chemotherapy to the head and neck regions with a minimum expected radiation dose of 60 Gy over 6 weeks - Chemotherapy may include but is not limited to, cisplatin or carboplatin, fluorouracil, hydroxyurea, docetaxel, and/or cetuximab - Induction chemotherapy allowed PATIENT CHARACTERISTICS: - Karnofsky performance status 50-100% - No prior allergic reaction or known sensitivity to dornase alfa inhalation solution - No significant active infection or other severe complicating medical illness - Not pregnant or nursing - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: - See Disease Characteristics - No concurrent amifostine - No mouth wash 1 hour before or after dornase alfa inhalation solution administration

Additional Information

Official title A Pilot Study of Pulmozyme (rhDNase) in Patients With Head and Neck Cancers Treated With Radiation and Chemotherapy
Description OBJECTIVES: - 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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2013.
Information provided to ClinicalTrials.gov by Northwestern University.