Patients receiving high dose chemotherapy
Conditions
Interventions
Group 1: Application of photobiomodulation therapy with the begin of high dose chemotherapie until resolution of oral mucositis or until neutrophil engraftment.
Group 2: Application of crytherapy with
Sponsors
UCCSH Universitäres Cancer Center Schleswig-Holstein
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Written informed consent in accordance with federal, local, and institutional guidelines. The patient must provide informed consent prior to the first screening procedure. 2. Age = 18 years 3. Eastern Cooperative Oncology Group (ECOG) performance status of = 3 4. Indication to receive high-dose chemotherapy with high potential to induce oral mucositis, including the following protocols - HD-M: High dose Melphalan (140 mg/m² for =55 years of age or 200 mg/m² for <55 years) - FTM: Fludarabine (4 x 30 mg/kg BW), Thiotepa (2 x 5 mg/kg body weight), Melphalan (110 mg/m² for =55 years of age or 140 mg/m² for <55 years) - Flu-Mel: Fludarabine (4 x 30 mg/kg BW), Melphalan (110 mg/m² for =55 years of age or 140 mg/m² for <55 years) - BEAM: Carmustine (300 mg/m2), Etoposide (4 x 200 mg/m2), Cytarabine/Ara-C (8 x 200 mg/m2), Melphalan (110 mg/m² for =55 years of age or 140 mg/m² for <55 years) - TEAM: Thiotepa (2 x 5 mg/kg body weight), Etoposide (4 x 200 mg/m2), Cytarabine/Ara-C (8 x 200 mg/m2), Melphalan (110 mg/m² for =55 years of age or 140 mg/m² for <55 years) - HD-MTX: High-dose MTX as defined by an MTX dose equal or greater than 0.5 g/m² body surface area 5. The indication to receive the high-dose chemotherapy and which therapy to apply must be decided on by an independent tumour or transplantation conference. 6. Ability to understand and willingness to sign a written informed consent
Exclusion criteria
Exclusion criteria: 1. Patients with an active autoimmune disease and/or viremia of the human immunodeficiency virus 2. Any degree of oral mucositis prior to the initiation of treatment 3. Individuals unable to apply photobiomodulation therapy or cryotherapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of severe oral mucositis as assessed by the treating or investigating physician. Exploration and clinical assessment are used to determine the grade of oral mucositis according to the World Health Organization mucositis grading scale. Severe oral mucositis is defined as grade 3 or 4 in the WHO mucositis grading scale. Assessment will occur daily for the duration of the inpatient stay, beginning with the first day of the application of photobiomodulation therapy or cryotherapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Duration of oral mucositis of different grades - The total rate of oral mucositis (grades 1-4) - Average grade of oral mucositis - Patient reported pain as evaluated by the Visual Analogue Scale - Number of days with total parenteral nutrition - Total dose of opioid analgesics converted to morphine equivalents - Peak C-reactive Protein - Maximum weight loss, defined as initial value upon admission minus the lowest value - Maximum difference in serum-Albumin, defined as the difference of the initial value upon admission minus the lowest value - number of days in neutropenia, defined as an absolute neutrophil count <0.5 × 10^9 cells/l - length of in-patient admission - cumulative employment of labor by nursing - Overall survival on d100 | — |
Countries
Germany
Contacts
Public ContactLars Fransecky
Klinik für Innere Medizin II, Universitätsklinikum Schleswig-Holstein, Campus Kiel
Outcome results
None listed