The Use of Chewing Gum for Xerostomia and Hyposalivation After Radiotherapy for Oral and Oropharyngeal Tumors

NCT03302676 | Completed DMC

• 1 other identifier: S-20160053
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the possible benefits of a tasteless and sugar free chewing gum as a salivary stimulant for head and neck cancer patients treated with curative intended radiotherapy.

Conditions

Head and Neck Cancer; Radiation Therapy Complication; Xerostomia; Hyposalivation

Keywords

Saliva substitute

Outcome Measures

Primary Outcomes (1)

• Salivary flow (intervention arm)

  Patients in the intervention arm will experience increase in stimulated salivary flow at follow up as compared to unstimulated salivary flow at baseline.

  1 month

Secondary Outcomes (1)

• Salivary flow (both groups of patients)

  1 month

Study Arms (2)

Intervention

ACTIVE COMPARATOR

Patients use tasteless and sugar free chewing gum up to 5 times a day for 1 month. Daily registrations in a patient dairy.

Dietary Supplement: Chewing gum

Control

NO INTERVENTION

Patients continue with daily routine to relieve oral discomfort. No chewing gum allowed.

Interventions

Chewing gum DIETARY_SUPPLEMENT

Intervention

Eligibility Criteria

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

You may qualify if:

• Over 18 years of age
• Diagnosed with oral or oropharyngeal carcinoma
• Received curative intended radiation therapy (primary or postoperative), 60-66Gy including concurrent chemotherapy
• Within 6 to 60 months after radiation therapy
• Complains of xerostomia level 1 (according to Danish Head and Neck Cancer group)
• Written informed consent

You may not qualify if:

• Poor teeth condition or full set of dentures
• Recurrence of cancer or palliative treatment

Sponsors & Collaborators

• Odense University Hospital: lead
• Danish Cancer Society: collaborator
• Odense Patient Data Explorative Network: collaborator

Study Sites (1)

Odense University Hospital

Odense, Danmark, 5000, Denmark

Location

Related Publications (1)

• Kaae JK, Stenfeldt L, Hyrup B, Brink C, Eriksen JG. A randomized phase III trial for alleviating radiation-induced xerostomia with chewing gum. Radiother Oncol. 2020 Jan;142:72-78. doi: 10.1016/j.radonc.2019.09.013. Epub 2019 Oct 9.

  PMID: 31606226 DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms; Xerostomia

Interventions

Chewing Gum

Condition Hierarchy (Ancestors)

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

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

Study Officials

• Julie K Kaae, MD

  Odense University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Model Details: 2:1 randomization in favor of chewing gum (intervention)

Study Record Dates

• First Submitted: October 2, 2017
• First Posted: October 5, 2017
• Study Start: September 1, 2016
• Primary Completion: September 1, 2018
• Study Completion: January 1, 2019
• Last Updated: March 14, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)