Study Using Intensity-modulated Radiation Therapy in Patients With Nasopharynx Cancer to Permit Sparing of Contralateral Parotid Gland Function

NCT00123864 | Completed Phase 1

• 1 other identifier: HN-4-0003
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

One of the side effects of standard radiation therapy for cancer of the nasopharynx is a permanent lessening of normal mouth moisture (saliva). This reduction in saliva is important because it causes a feeling of dry mouth, and has been shown to increase the risk of dental cavities and infections; change or decrease the ability to taste certain foods; and make chewing and swallowing food more difficult. Recent technical advances in radiation therapy offer the possibility of shielding a portion of one of the major salivary glands (parotid gland) from receiving a dose of radiation that would eliminate its ability to produce saliva, while still treating all sites of known cancer effectively. Recently, cancer researchers in Ann Arbor, Michigan used this new treatment technique to treat patients with head and neck cancers (but none with nasopharyngeal cancer), and found that patients treated in this manner still had significant saliva production from the spared gland. This study will try to use the treatment planning technique called intensity-modulated radiation therapy to protect a portion of one parotid gland while treating all known and suspected areas of cancer to full radiation doses.

Conditions

Nasopharyngeal Neoplasms

Keywords

intensity modulated radiation therapy; parotid; nasopharyngeal carcinoma

Outcome Measures

Primary Outcomes (1)

• rate of grade 2 xerostomia

Secondary Outcomes (1)

• feasibility

Interventions

Intensity-modulated radiation therapy PROCEDURE

Eligibility Criteria

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

You may qualify if:

• Epithelial carcinoma of the nasopharynx, oral cavity, oropharynx, larynx, or hypopharynx

You may not qualify if:

• Previous therapy for carcinoma of head/neck

Sponsors & Collaborators

• Alberta Health services: lead

Study Sites (1)

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

Related Publications (1)

• Parliament MB, Scrimger RA, Anderson SG, Kurien EC, Thompson HK, Field GC, Hanson J. Preservation of oral health-related quality of life and salivary flow rates after inverse-planned intensity- modulated radiotherapy (IMRT) for head-and-neck cancer. Int J Radiat Oncol Biol Phys. 2004 Mar 1;58(3):663-73. doi: 10.1016/S0360-3016(03)01571-2.

  PMID: 14967418 BACKGROUND

MeSH Terms

Conditions

Nasopharyngeal Neoplasms; Nasopharyngeal Carcinoma

Interventions

Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Study Officials

• Matthew Parliament, MD

  Cross Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 22, 2005
• First Posted: July 26, 2005
• Study Start: January 1, 2000
• Last Updated: February 9, 2010

Record last verified: 2005-07

Locations

CA (1)