Evaluation of an Oral Care Programme for Head and Neck Cancer Patients

NCT03481647 | Recruiting

• 1 other identifier: 831-16
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

Brief Summary

This study will evaluate the effect of an intensified oral care programme on prevalence, severity and duration of mucositis in patients undergoing treatment for cancer in the head and neck region. Patients in the control group get professional oral care once a week.

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (6)

• Oral mucositis

  Reduced incidence of clinical mucositis assessed using Oral Mucositis Assessment Scale (9 areas in the mouth are examined and signs of ulceration are scored; 0=no lesion,1= lesion \<1cm2, 2=lesion 1-3 cm2, 3=lesion \> 3 cm2 as well as erythema, which is scored as follows: 0=no erythema, 1= mild erythema and 2=severe erythema. Total score for ulceration can vary from 0-27 and for erythema from 0-18. Mucositis is present at scores ≥ 1.)

  First week of RT (mucositis score at one time-point)

• Oral mucositis

  Reduced incidence of clinical mucositis assessed using Oral Mucositis Assessment Scale (9 areas in the mouth are examined and signs of ulceration are scored; 0=no lesion,1= lesion \<1cm2, 2=lesion 1-3 cm2, 3=lesion \> 3 cm2 as well as erythema, which is scored as follows: 0=no erythema, 1= mild erythema and 2=severe erythema. Total score for ulceration can vary from 0-27 and for erythema from 0-18. Mucositis is present at scores ≥ 1.)

  Second week of RT (mucositis score at one time-point)

• Oral mucositis

  Reduced incidence of clinical mucositis assessed using Oral Mucositis Assessment Scale (9 areas in the mouth are examined and signs of ulceration are scored; 0=no lesion,1= lesion \<1cm2, 2=lesion 1-3 cm2, 3=lesion \> 3 cm2 as well as erythema, which is scored as follows: 0=no erythema, 1= mild erythema and 2=severe erythema. Total score for ulceration can vary from 0-27 and for erythema from 0-18. Mucositis is present at scores ≥ 1.)

  Third week of RT (mucositis score at one time-point)

• Oral mucositis

  Reduced incidence of clinical mucositis assessed using Oral Mucositis Assessment Scale (9 areas in the mouth are examined and signs of ulceration are scored; 0=no lesion,1= lesion \<1cm2, 2=lesion 1-3 cm2, 3=lesion \> 3 cm2 as well as erythema, which is scored as follows: 0=no erythema, 1= mild erythema and 2=severe erythema. Total score for ulceration can vary from 0-27 and for erythema from 0-18. Mucositis is present at scores ≥ 1.)

  Fourth week of RT (mucositis score at one time-point)

• Oral mucositis

  Reduced incidence of clinical mucositis assessed using Oral Mucositis Assessment Scale (9 areas in the mouth are examined and signs of ulceration are scored; 0=no lesion,1= lesion \<1cm2, 2=lesion 1-3 cm2, 3=lesion \> 3 cm2 as well as erythema, which is scored as follows: 0=no erythema, 1= mild erythema and 2=severe erythema. Total score for ulceration can vary from 0-27 and for erythema from 0-18. Mucositis is present at scores ≥ 1.)

  Fifth week of RT (mucositis score at one time-point)

• Oral mucositis

  Reduced incidence of clinical mucositis assessed using Oral Mucositis Assessment Scale (9 areas in the mouth are examined and signs of ulceration are scored; 0=no lesion,1= lesion \<1cm2, 2=lesion 1-3 cm2, 3=lesion \> 3 cm2 as well as erythema, which is scored as follows: 0=no erythema, 1= mild erythema and 2=severe erythema. Total score for ulceration can vary from 0-27 and for erythema from 0-18. Mucositis is present at scores ≥ 1.)

  Sixth week of RT (mucositis score at one time-point)

Study Arms (2)

Intervention

ACTIVE COMPARATOR

The intervention consists of professional oral care and swabbing of the mucosal membranes with a saline and bicarbonate solution, five daily rinses with a saline and bicarbonate solution, a diary to register oral care measures and rinses

Procedure: Oral care programme

Control

NO INTERVENTION

Professional oral care once a week according to existing routine

Interventions

Oral care programme PROCEDURE

Professional oral care (dental hygienist), intensified oral care measures by the patient

Intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled to receive full dose of curative RT including major salivary glands in the radiation field

You may not qualify if:

• Patients with recurrent cancer
• Patients with severe cognitive impairment.

Sponsors & Collaborators

• Göteborg University: lead
• Ryhov County Hospital: collaborator
• Region Jönköping County: collaborator
• Swedish Cancer Foundation: collaborator
• Kalmar County Hospital: collaborator
• Norrlands University Hospital: collaborator
• The Sjöberg Foundation: collaborator
• TUA research funding: The Sahlgrenska Academy/Region Västra Götaland: collaborator
• Malmö University: collaborator

Study Sites (2)

Institute of odontology

Gothenburg, 41390, Sweden

ACTIVE NOT RECRUITING

Länssjukhuset Ryhov

Jönköping, Sweden

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Annica Almståhl, Assoc.prof

  Göteborg University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Annica Almståhl, Assoc.prof

CONTACT

+46317863208; annica.almstahl@odontologi.gu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participants will not be aware of the care/treatment given to the other group
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Intervention group: intensified oral care programme Control group: conventional oral care

Study Record Dates

• First Submitted: January 16, 2018
• First Posted: March 29, 2018
• Study Start: January 8, 2018
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 20, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)