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Clinical Trials in Sweden / NCT03481647
Recruiting Not applicable

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

NCT03481647 · tracked via the Priya Life Science Sweden tracker
Sponsor
Göteborg University
Phase
Not applicable
Started
2018-01-08
Last updated
2025-04-20

Condition(s) studied

Head and Neck Cancer

Investigational drug(s) / intervention(s)

Oral care programme

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: * Patients scheduled to receive full dose of curative RT including major salivary glands in the radiation field Exclusion Criteria: * Patients with recurrent cancer * Patients with severe cognitive impairment.

Primary outcome measure(s)

  • Oral mucositis — First week of RT (mucositis score at one time-point)
    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.)
  • Oral mucositis — Second week of RT (mucositis score at one time-point)
    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.)
  • Oral mucositis — Third week of RT (mucositis score at one time-point)
    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.)
  • Oral mucositis — Fourth week of RT (mucositis score at one time-point)
    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.)
  • Oral mucositis — Fifth week of RT (mucositis score at one time-point)
    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.)
  • Oral mucositis — Sixth week of RT (mucositis score at one time-point)
    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.)

Trial sites (2)

FacilityCityRegionStatus
Institute of odontology Gothenburg Sweden Active Not Recruiting
Länssjukhuset Ryhov Jönköping Sweden Recruiting

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Other trials for the same condition

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03481647 on ClinicalTrials.gov ↗ ← All trials in Sweden