ClinicalTrials.gg
RecruitingNCT03481647Updated Apr 20, 2025

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

An interventional study of Oral care programme in Head and Neck Cancer, sponsored by Göteborg University. Recruiting at 2 sites in Sweden. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-04-20.

Sponsored by Göteborg University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Started Jan 2018; still recruiting 8 years 10 months later.

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Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 34 studies in Head and Neck Neoplasms with a site in Sweden — 10 open to participants now, 13 under way, 2 of them phase 3. Head and Neck Neoplasms · Sweden.

Planned enrollment
14th of 26
150 · median 187
Started
2018
with 1 other
No phase
9 of 34
3 open now
Primary completion
2026-12
later than 5 of 12 live
Registered
13th of 34
by date

Among the 34 studies in Head and Neck Neoplasms with a site in Sweden, this one is the 14th largest by planned enrollment of the 26 interventional ones that give a count, is one of 2 that started in 2018, is one of 9 with no phase, reaches primary completion later than 5 of the 12 other live ones, and was the 13th registered.

Head and Neck Neoplasms

2,713 studies on the registry are indexed under Head and Neck Neoplasms; 596 are open to participants now.

Browse Head and Neck Neoplasms studies →

Open to participants now

10 of the 34 studies in Head and Neck Neoplasms with a site in Sweden are open now. Recruiting first, the newest first:

4 more — sign in →

All 10 open studies →

A study can be open while its sites in Sweden have not opened yet or have stopped. Only those recruiting at a site in Sweden →

Who these studies take

Of the 453 Head and Neck Neoplasms studies recruiting now, 345 (76%) set no upper age limit and 51 (11%) stop at 75 or younger; 21 take children under 18; 27 take healthy volunteers.

This study: 18 Years to 80 Years · all sexes · no healthy volunteers.

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02

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.

Read the detailed description

This study will evaluate the effect of an oral care programme on prevalence, severity and duration of mucositis in patients undergoing treatment for cancer in the head and neck region. The oral care programme consists of professional oral care and swabbing of the mucosal membranes with a saline/bicarbonate solution once a week. The patients are instructed to rinse with a saline/bicarbonate solution 5 times per day. They are given an oral care diary to help them keep track of their daily oral hygiene measures and rinses. Repeated oral hygiene instructions are given if needed.

Patients in the control group get professional oral care once a week.

03

Conditions studied

  • Head and Neck Cancer
04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Patients with recurrent cancer
  • Patients with severe cognitive impairment.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
150 participants (estimated)

Study arms

  • Active comparator
    Intervention

    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

  • No intervention
    Control

    Professional oral care once a week according to existing routine

Interventions

  • ProcedureOral care programme

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

06

What researchers measure

Primary outcomes

  1. 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.)

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

  2. 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.)

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

  3. 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.)

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

  4. 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.)

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

  5. 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.)

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

  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.)

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

07

Study locations

1 of 2 sites recruiting
  • Institute of odontology
    Gothenburg, 41390, Sweden
    Active, not recruiting

    Not enrolling at this site.

  • Länssjukhuset Ryhov
    Jönköping, Sweden
    Recruiting
08

References and documents

Individual participant data

Plan to share: No — We are not planning to make IPD available to researchers not involved in the project

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2018 (actual). Primary completion is estimated for Dec 2026, 107 months after the start.

Of 437 non-industry interventional studies with no phase under Head and Neck Neoplasms, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 71. This study's planned 107 months is above that.

Counting every sponsor, half of 455 studies reached it within 33 months; a quarter within 18 and three quarters within 70.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 16, 2018
First posted
Mar 29, 2018
StartActual
Jan 8, 2018
Primary completionEst.
Dec 31, 2026
CompletionEst.
Dec 31, 2026
Last update
Apr 20, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 20, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03481647
Collaborators
Ryhov County Hospital, Region Jönköping County, Swedish Cancer Foundation, Kalmar County Hospital, Norrlands University Hospital, The Sjöberg Foundation, TUA research funding: The Sahlgrenska Academy/Region Västra Götaland, Malmö University
Responsible party
Sponsor
First posted
Mar 29, 2018
Start date
Jan 8, 2018
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Apr 20, 2025

Study contacts

Annica Almståhl, Assoc.prof
Contact
annica.almstahl@odontologi.gu.se
+46317863208
Annica Almståhl, Assoc.prof
principal investigator · Göteborg University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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