Patients with solid or hematological malignancies receiving outpatient systemic anticancer therapy (e.g., chemotherapy, immunotherapy, targeted therapies) for the assessment and longitudinal observation of therapy-associated oral symptoms.
Conditions
Interventions
Group 1: Patients receiving outpatient systemic cancer therapy at the UCT Frankfurt are surveyed within the first 1–2 weeks after the start of treatment. Subjective oral symptoms are assessed using a
Sponsors
Medizinische Klinik 1
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Participants must be starting a systemic cancer therapy (e.g., immune checkpoint inhibitors, chemotherapy, or other targeted therapies). At the time of the initial assessment, participants must be within the first 1–2 weeks after the start of treatment. Since oral symptoms are to be recorded over time up to a third examination after 8-9 weeks, a planned treatment duration of at least nine weeks is required. Furthermore, participants must be able to provide informed consent and be capable of completing the patient-reported questionnaires either orally or in writing. In addition, they must be physically able to tolerate the scheduled clinical examinations.
Exclusion criteria
Exclusion criteria: Patients with pre-existing, severe oral mucosal diseases that do not allow for a clear attribution of therapy-associated oral symptoms. Furthermore, patients who have received systemic cancer therapy within the last 12 months are excluded, as any occurring oral symptoms in these cases cannot be unequivocally attributed to the current treatment. Additional exclusion criteria include planned or ongoing radiotherapy in the head and neck region, severe cognitive impairment or psychiatric disorders that preclude a valid completion of the questionnaires or the ability to provide informed consent, as well as a generally reduced state of health that does not permit the performance of the scheduled clinical examinations.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoints are the individual scores of the following five subjectively perceived oral symptoms: xerostomia, dysgeusia, mucositis, dysphagia, and lingual changes. These data are collected via questionnaires at two time points: initially (1–2 weeks after the start of therapy) and at a 4–5 week follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints include the severity of the five above-mentioned subjectively perceived oral symptoms in the extended longitudinal course after an additional 4–5 weeks of follow-up (a total of 8–9 weeks after treatment initiation), as well as further subjectively perceived symptoms, which are also assessed using specific questionnaires. Additionally, clinically assessed findings and the extent of subjectively experienced reductions in quality of life due to oral symptoms will be evaluated, as measured by the validates OHIP-G-14. | — |
Countries
Germany
Contacts
Public ContactChristine Koch
Medizinische Klinik 1
Outcome results
None listed