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Evaluation of the effect of erythropoetin mouthwash in mucositis

Evaluation of the effect of erythropoetin mouthwash in preventing the incidence and decreasing severity of mucositis in patients undergoing autologous bone marrow transplantation

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2015042518842N8
Enrollment
80
Registered
2015-05-03
Start date
2014-02-20
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Condition 1: multiple myeloma. Condition 2: Non-Hodgkin lymphoma. Condition 3: Hodgkin lymphoma. multiple myeloma Non-Hodgkin lymphoma, unspecified Hodgkin lymphoma, unspecified

Interventions

Intervention 1: erythropoietin mouthwash (50 IU/mL, 15 ml four times a day from starting day of preparing chemotherapy until day +14 after transplantation. Intervention 2: pelacebo mouthwash (50 IU/mL
Prevention
Placebo
erythropoietin mouthwash (50 IU/mL, 15 ml four times a day from starting day of preparing chemotherapy until day +14 after transplantation
pelacebo mouthwash (50 IU/mL, 15 ml four times a day from starting day of preparing chemotherapy until day +14 after transplantation

Sponsors

Hematology, Oncology and Stem Cell Transplantation Research Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: inclusion criteria: age of at least 18 years old; patients with NHL, HD or MM receiving conditioning chemotherapy before autologousHSCT; signing written informed consent. exclusion criteria: Karnofsky performance status <70% or participation in another study; using an unlicensed product.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Incidence, severity and duration of oral mucositis. Timepoint: The starting day of preparing chemotherapy until day +21 after transplantation. Method of measurement: Daily oral examination based on the WHO criteria for grading mucositis.

Secondary

MeasureTime frame
Neutrophil and platelet engraftment. Timepoint: The starting day of preparing chemotherapy until day +21 after transplantation. Method of measurement: CBC test.;Duration of neutropenia. Timepoint: The starting day of preparing chemotherapy until day +21 after transplantation. Method of measurement: CBC test.;Duration of fever due to neutropenia. Timepoint: The starting day of preparing chemotherapy until day +21 after transplantation. Method of measurement: Temperatures measured under the tongue.;Duration of hospitalization. Timepoint: Discharge Time. Method of measurement: The number of hospitalization days.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHesamodin Hosseinjani

School of Pharmacy, Tehran University of Medical Sciences

hosseinjanih@yahoo.com+98 21 6643 5807

Outcome results

None listed

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