Study to pilot-test an oral care self-management support protocol (OrCaSS) regarding feasability and effectiveness in patients with acute myeloid leukemia prior to allogeneic stem cell transplantation to prevent chemotherapy-related oral mucositis: a randomized, controlled pilot study

Study to pilot-test an oral care self-management support protocol (OrCaSS) regarding feasability and effectiveness in patients with acute myeloid leukemia prior to allogeneic stem cell transplantation to prevent chemotherapy-related oral mucositis: a randomized, controlled pilot study - OrCaSS

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00004309

Enrollment

Registered

2012-08-16

Start date

2012-08-20

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

K12.3

Interventions

Group 1: Patients in the control group will receive usual care which is based on a standard operating procedure (SOP) and includes oral cryotherapy for patients who receive Melphalane = 140mg/m2 and s

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Read and speak German, have no oral mucositis at the time of recruitment, are to perform oral care independently in the situation

Exclusion criteria

Exclusion criteria: diagnosed psychiatric disorderor any other disabilities which prevents an adequate communication

Design outcomes

Primary

Measure	Time frame
Duration, severity and incidence of OM OM is measured daily with the WHO toxicity scale from the day of admission until day 20 after transplantation	—

Secondary

Measure	Time frame
Adherence: is measured with the BAASIS and the plaque index on day of admission and at day 8,9 or 10 after transplantation Quality of life: is measured using the EORTC QLQ C30 1 week before transplantation, at the day of admission and at day 8,9 or 10 after transplantation Symptom Experience: is measured using PROVIVO at day 8,9 or 10 after transplantation	—

Countries

Germany

Contacts

Public ContactLynn Leppla

Universitätsklinik Freiburg Abteilung Hämatologie/Onkologie

lynn.leppla@uniklinik-freiburg.de0761-270-34190

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026