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Effect of Oral Cryotherapy and Normal Saline Mouth Rinse on Chemotherapy –Induced Oral Mucositis in Patients with Blood Stem-Cell Transplantation

Effect of Oral Cryotherapy and Normal Saline Mouth Rinse on Chemotherapy –Induced Oral Mucositis in Patients with Autologous Blood Stem-Cell Transplantation: A Randomized clinical Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT201307165665N4
Enrollment
60
Registered
2013-10-15
Start date
2013-10-06
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

oral mucositis. oral mucositis-ulcerative

Interventions

Intervention 1: In intervention group (ice-therapy) the small ice pieces will prepare in plastic freezer disposable formats (casts) with ready clean mineral water in dedicated refrigerator of each pat
Prevention
In intervention group (ice-therapy) the small ice pieces will prepare in plastic freezer disposable formats (casts) with ready clean mineral water in dedicated refrigerator of each patient. During che
In saline rinse group, the participants will be asked to rinse their mouth by a saline solution with the room temperature (23-29 centigrade degree), 30 minutes before chemotherapy to 6 hours after it,

Sponsors

Nursing and Midwifery Faculty- Vice chancellor for research
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Consciousness; Age between 18 to 70 years; To have Hodgkin's, non Hodgkin's lymphoma or Multiple Myeloma with the same grades; To have healthy oral mucous; Isolation of participants from the beginning of the project; To have Similar Chemotherapy properties; To have the same Autologous transplantation protocols Exclusion criteria: Participants’ dissatisfaction; Loss of consciousness; Suffering from other diseases during treatment; use of narcotic analgesics continuously before the study; Combined therapies such as radiation therapy at the time of study; Fever, neutropenia and mucositis before starting treatment; To have respiratory diseases such as asthma and oral infections; Systemic diseases effective on oral tissues, especially periodontal disease; To have chemotherapy two weeks before transplantation; Change in treatment protocol during the study

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Oral Mucositis. Timepoint: before chemotherapy and 3rd, 7th, 14th and21th days folowing end of chemotherapy. Method of measurement: WHO Mucositis Scale.

Secondary

MeasureTime frame
Nausea and Vomiting. Timepoint: During 4 days, every day following end of chemotherapy. Method of measurement: checklist.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMarzieh Askarifar

Tabriz University of Medical Sciences

marzieh.askarifar@yahoo.com+98 41 1477 0648

Outcome results

None listed

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