Oral care program for patients with head and neck cancer
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
NA · Göteborg University · NCT03481647
This study tests if a special oral care program can help people with head and neck cancer have less mouth soreness during their treatment compared to standard care.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Göteborg University (other) |
| Drugs / interventions | radiation |
| Locations | 2 sites (Gothenburg and 1 other locations) |
| Trial ID | NCT03481647 on ClinicalTrials.gov |
What this trial studies
This study evaluates the impact of an intensified oral care program on the prevalence, severity, and duration of mucositis in patients undergoing treatment for head and neck cancer. Participants will receive professional oral care and will be instructed to perform daily rinses with a saline/bicarbonate solution. The program includes weekly professional care and the use of an oral care diary to track hygiene practices. A control group will receive standard oral care once a week for comparison.
Who should consider this trial
Good fit: Ideal candidates are patients scheduled to receive full-dose curative radiation therapy that includes major salivary glands in the radiation field.
Not a fit: Patients with recurrent cancer or severe cognitive impairment may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly reduce the incidence and severity of mucositis, improving the quality of life for head and neck cancer patients during treatment.
How similar studies have performed: Other studies have shown that improved oral care can positively impact mucositis in cancer patients, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Gothenburg and 1 other locations
- Institute of odontology — Gothenburg, Sweden (ACTIVE_NOT_RECRUITING)
- Länssjukhuset Ryhov — Jönköping, Sweden (RECRUITING)
Study contacts
- Principal investigator: Annica Almståhl, Assoc.prof — Göteborg University
- Study coordinator: Annica Almståhl, Assoc.prof
- Email: annica.almstahl@odontologi.gu.se
- Phone: +46317863208
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Head and Neck Cancer