Comparing Over-the-counter Dry Mouth Remedies After Radiation

NCT00595933 | Completed Phase 1

• 2 other identifiers: Dry Mouth_KremplIRB # 12518
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the effectiveness of over-the-counter remedies for dry mouth.

Conditions

Xerostomia

Keywords

Head and Neck cancer; Radiation therapy; Dry mouth remedies; Dry Mouth; Xerostomia

Outcome Measures

Primary Outcomes (1)

• The effectiveness of seven over-the-counter remedies for dry mouth as determined by amount of saliva output and a brief questionaire.

  8-10 weeks

Study Arms (1)

1

EXPERIMENTAL

Each participant will receive an unidentified product to use for a one week period. This will continue until all 7 dry-mouth products have been evaluated.

Other: sugar-free chewing gum; Other: chewing gum; Other: mouth rinse; Drug: mouth spray

Interventions

sugar-free chewing gum OTHER

Chew gum 4 times a day with additional allowances for as needed. Fill out daily questionaire and an end of week.

Also known as: Freedent chewing gum

1

chewing gum OTHER

Chew gum 4 times a day with additional allowances for as needed. Fill out daily questionaire and an end of week.

Also known as: Biotene chewing gum

1

mouth rinse OTHER

Rinse mouth 4 times a day with additional allowances for as needed. Fill out daily questionaire and an end of week questionaire

Also known as: Flavored water

1

mouth spray DRUG

Spray mouth with mouth spray 4 times a day with additional allowances for as needed. Fill out daily questionaire and an end of week

Also known as: Salivart

1

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Suffers from Xerostomia
• Surviver of head and neck cancer that received \>5000 cGy radiation therapy \>1 year prior to study entry.
• Able to chew, rinse and swallow.
• Ages 13-99 years of age

You may not qualify if:

• Currently using the following medications: anorexiants, antiacne agents, Anticholinergic agents, tricyclic antidepressants, chemotherapy agents.
• Unable to complete questionnaires

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Conditions

Xerostomia; Head and Neck Neoplasms

Interventions

Chewing Gum; Mouthwashes

Condition Hierarchy (Ancestors)

Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Plant Gums; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Plant Exudates; Biological Products; Complex Mixtures; Candy; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Biomedical and Dental Materials; Specialty Uses of Chemicals; Chemical Actions and Uses; Cosmetics; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Greg Krempl, MD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2007
• First Posted: January 16, 2008
• Study Start: March 1, 2005
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: September 7, 2022

Record last verified: 2022-09

Locations

US (1)