Clinical trial · Interventional
Pilot Study of Pulmozyme (rhDNase) in Patients With Head and Neck Cancers Treated With Radiation Therapy + Chemotherapy
A Pilot Study of Pulmozyme (rhDNase) in Patients With Head and Neck Cancers Treated With Radiation and Chemotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Drug | — | UNRESOLVED |
| Pulmozyme | Drug | — | UNRESOLVED |
| Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm 1
- description
- Pulmozyme
- interventionNames
- Drug: Pulmozyme
- Radiation: Radiation Therapy
- type
- PLACEBO_COMPARATOR
- label
- Arm 2
- description
- Placebo
- interventionNames
- Drug: Placebo
- Radiation: Radiation Therapy
Primary outcomes (3)
- measure
- Treatment-related symptoms as assessed daily by the Head and Neck Symptom Inventory Scale (MD Anderson Symptom Inventory)
- timeFrame
- 5 times per week during study treatment and once per month up to 3 months post-treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 administrationReferences
Publications (0)
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