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Xerostomia in Head and Neck Cancer Patients Receiving Radiation as the Primary Treatment Versus Patients Who Will Not Have Such a Procedure

A

AHS Cancer Control Alberta

Status and phase

Completed
Phase 2

Conditions

Head and Neck Cancer

Treatments

Procedure: radiation alone
Procedure: radiation treatment and surgery

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

The purpose of this study is to compare the side effects of radiation treatment and surgery versus radiation alone, where no surgery is done to move the salivary gland and place it under the chin region where it can be shielded from radiation.

Enrollment

42 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients with a histological diagnosis of squamous cell carcinoma
  • Patients with unilateral or no neck involvement of the nasopharynx
  • The submandibular transfer will be done on the uninvolved side of the neck.
  • Karnofsky score greater than or equal to 70
  • Expected survival greater than one year
  • A signed informed consent

Exclusion criteria

  • Bilateral neck nodes involvement. Involvement of level 1 lymph nodes on the side of the proposed procedure.

Trial design

Primary purpose

Prevention

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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