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Trial record 47 of 1256 for:    Recruiting, Not yet recruiting, Available Studies | "Head and Neck Neoplasms"

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

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ClinicalTrials.gov Identifier: NCT03481647
Recruitment Status : Recruiting
First Posted : March 29, 2018
Last Update Posted : March 29, 2018
Sponsor:
Collaborators:
Ryhov County Hospital
FUTURUM, Academy of Health and Science
Swedish Cancer Foundation
Information provided by (Responsible Party):
Göteborg University

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.


Condition or disease Intervention/treatment Phase
Head and Neck Cancer Procedure: Oral care programme Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Intervention group: intensified oral care programme Control group: conventional oral care
Masking: Single (Participant)
Masking Description: The participants will not be aware of the care/treatment given to the other group
Primary Purpose: Prevention
Official Title: Evaluation of an Oral Care Programme for Patients Undergoing Treatment for Head and Neck Cancer Regarding Mucositis, Oral Health, Epigenetic Modifications, Patient-related Factors, Quality of Life and Health Economy
Actual Study Start Date : January 8, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Professional oral care (dental hygienist), intensified oral care measures by the patient

No Intervention: Control
Professional oral care once a week according to existing routine



Primary Outcome Measures :
  1. Oral mucositis [ Time Frame: 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.)

  2. Oral mucositis [ Time Frame: 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.)

  3. Oral mucositis [ Time Frame: 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.)

  4. Oral mucositis [ Time Frame: 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.)

  5. Oral mucositis [ Time Frame: 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.)

  6. Oral mucositis [ Time Frame: 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.)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with ≥ 16 own teeth and no removable dentures,
  • Patients scheduled to receive full dose of RT including the major salivary glands in the radiation field

Exclusion Criteria:

  • Patients who get surgery to remove their tumor
  • Patients with recurrent cancer
  • Patients with severe cognitive impairment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03481647


Contacts
Contact: Annica Almståhl, Assoc.prof +46317863208 annica.almstahl@odontologi.gu.se

Locations
Sweden
Institute of odontology Active, not recruiting
Gothenburg, Sweden, 41390
Länssjukhuset Ryhov Recruiting
Jönköping, Sweden
Contact: Charlott Karlsson, RDH    +4636326000    charlott.karlsson@rjl.se   
Sponsors and Collaborators
Göteborg University
Ryhov County Hospital
FUTURUM, Academy of Health and Science
Swedish Cancer Foundation
Investigators
Principal Investigator: Annica Almståhl, Assoc.prof Göteborg University

Responsible Party: Göteborg University
ClinicalTrials.gov Identifier: NCT03481647     History of Changes
Other Study ID Numbers: 831-16
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We are not planning to make IPD available to researchers not involved in the project

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms