Phase 2 N=49 Supportive Care

Salivary Gland Surgery Before Radiation Therapy in Preventing Radiation-Caused Xerostomia in Patients With Head and Neck Cancer

Head and Neck Cancer · Radiation Toxicity · Xerostomia

Bottom Line

View on ClinicalTrials.gov: NCT00068237 ↗

Enrolled (actual)

Serious AEs

4.6%

Results posted

Jan 2014

Primary outcome: Primary: Number of Patients Scored as Having the Surgical Technique of Submandibular Salivary Gland Transfer Performed "Per Protocol" — 34 participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: salivary gland transfer (Procedure); Post-operative radiation therapy (Radiation)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Radiation Therapy Oncology Group
Primary completion: Jan 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Patients Scored as Having the Surgical Technique of Submandibular Salivary Gland Transfer Performed "Per Protocol"	34	—
SECONDARY Percentage of Patients With Acute Xerostomia	25.6	—
SECONDARY Percentage of Patients With Normal Functioning Transferred Submandibular Gland	70.3; 16.7; 0.0	—
SECONDARY Change From Baseline to One Year in Total Score on the Modified University of Washington Head and Neck Symptom Questionnaire	13.6	—
SECONDARY Percentage of Patients Experiencing Facial Edema Following Surgery	13.6	—
SECONDARY Percentage of Patients Experiencing Acute Grade 3-4 Toxicity Definitely, Probably, or Possibly Related to Radiation Therapy or Chemotherapy	34.9	—
SECONDARY Percentage of Patients Experiencing Late Grade 3-4 Toxicity Definitely, Probably, or Possibly Related to Radiation Therapy	7.9	—
SECONDARY Disease-free Survival Rate at 2 Years	71.7	—
SECONDARY Overall Survival Rate at 2 Years	76.4	—

Summary

RATIONALE: Moving a salivary gland out of the area that will undergo radiation therapy may protect the gland from side effects of radiation therapy and may prevent xerostomia (dry mouth). PURPOSE: Phase II trial to study the effectiveness of salivary gland surgery in preventing xerostomia in patients who are undergoing radiation therapy for head and neck cancer.

Eligibility Criteria

DISEASE CHARACTERISTICS:

One of the following diagnoses:
Histologically confirmed, previously untreated squamous cell carcinoma of the oropharynx, hypopharynx, or larynx
Head and neck cancer of unknown primary with unilateral metastases to the neck nodes
No N3 disease
No carcinoma of the oral cavity or nasopharynx
No bilateral neck node involvement
No suspicious neck node on the contralateral neck or the side chosen for salivary gland transfer by CT scan or MRI
No pre-epiglottic space involvement
No involvement of level 1 nodes on either side of the neck
No salivary gland malignancy
No recurrent disease

PATIENT CHARACTERISTICS:

Age

At least 18 years old

Performance status

Zubrod 0-1

Life expectancy

Not specified

Hematopoietic

Hemoglobin at least 10 g/dL

Hepatic

Not specified

Renal

Not specified

Other

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No salivary gland disease (e.g., Sjögren's syndrome)
No other malignancy within the past 3 years except basal cell or squamous cell skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

More than 3 years since prior chemotherapy
No prior or concurrent neoadjuvant chemotherapy
Concurrent adjuvant chemoradiotherapy (in addition to study radiotherapy) allowed

Endocrine therapy

Not specified

Radiotherapy

See Chemotherapy
No prior radiotherapy to the head and neck
No concurrent intensity-modulated radiotherapy

Surgery

Not specified

Other

No concurrent cholinergic drugs
No concurrent anti-cholinergic drugs
No concurrent tricyclic drugs
No concurrent prophylactic amifostine or pilocarpine during and for at least 3 months after completion of study radiotherapy

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00068237). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.