Oral MucositisSOC-HSCTNCT07809451
Effect of a Standardized Oral Care Program on Oral Mucositis in Children Undergoing Hematopoietic Stem Cell Transplantation: A Randomized Controlled Trial(SOC-HSCT)
A study testing Standardized Oral Care Intervention and Routine Oral Care in people with Oral Mucositis and Hematopoietic Stem Cell Transplantation (HSCT), run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
Oral mucositis is one of the most common and debilitating complications in pediatric patients undergoing hematopoietic stem cell transplantation (HSCT). Severe oral mucositis can lead to pain, nutritional impairment, infection, prolonged hospitalization, and increased healthcare costs. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Oral Mucositis, Hematopoietic Stem Cell Transplantation (HSCT)
- What is being tested?
- Standardized Oral Care Intervention and Routine Oral Care
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2026to 1 Sep 2030
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- -Patients aged 1-18 years who undergo hematopoietic stem cell transplantation.
- Patients scheduled to receive conditioning therapy before hematopoietic stem cell transplantation.
- Patients and/or their legal guardians provide informed consent to participate in the study.
- Patients are able to receive oral care intervention and complete oral mucositis assessments during the study period.
Who cannot join
- Patients with pre-existing oral mucosal diseases or oral ulcers before transplantation.
- Patients with severe systemic conditions that may interfere with oral mucositis assessment.
- Patients who have received interventions specifically targeting oral mucositis prevention before enrollment.
- Patients or guardians who refuse to participate or withdraw informed consent.
- Patients who are unable to complete follow-up assessments during the study period.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515
Ting Chen, PhD, +86-020-62787939, chent@smu.edu.cn
Zhuoting yuan, +86-18279667334, 18279667334@163.com
About this study
Official title: Systematic Oral Hygiene Intervention for the Prevention and Control of Oral Mucositis in Children Undergoing Hematopoietic Stem Cell Transplantation During the Perioperative Period: A Prospective, Randomized Controlled Clinical Trial
Oral mucositis is one of the most common and debilitating complications in pediatric patients undergoing hematopoietic stem cell transplantation (HSCT). Severe oral mucositis can lead to pain, nutritional impairment, infection, prolonged hospitalization, and increased healthcare costs. This randomized controlled trial aims to evaluate whether a standardized oral care program consisting of caregiver education, supervised tooth brushing, sodium bicarbonate mouth rinsing, oral moisturizing, and compliance monitoring can reduce the incidence and severity of oral mucositis compared with routine oral care. A total of 126 pediatric HSCT recipients will be randomly assigned in a 1:1 ratio to the intervention or control group. Clinical outcomes, oral pain, inflammatory biomarkers, oral microbiota, and metabolomic profiles will be evaluated throughout the transplantation period.
Read the detailed description
Oral mucositis is one of the most frequent and clinically significant complications in pediatric patients receiving hematopoietic stem cell transplantation (HSCT). Characterized by painful inflammation and ulceration of the oral mucosa, oral mucositis can substantially impair oral intake, nutritional status, communication, and quality of life. In severe cases, it may increase the risk of bloodstream infections, require opioid analgesia, prolong hospitalization, and affect the overall course of transplantation.
Currently, preventive and supportive strategies for oral mucositis in HSCT patients mainly include oral hygiene maintenance, antimicrobial interventions, pain management, and symptomatic treatment. However, the incidence and severity of oral mucositis remain high, particularly in pediatric HSCT recipients, due to factors including intensive conditioning regimens, immature oral care behaviors, altered immune status, and changes in the oral microbiome. Therefore, effective, standardized, and feasible preventive oral care strategies are still needed.
Emerging evidence suggests that maintenance of oral microbial homeostasis and improvement of oral hygiene may play important roles in reducing mucosal injury and preventing the progression of oral mucositis. However, existing oral care protocols vary considerably among institutions, and the effectiveness of comprehensive standardized oral care programs in pediatric HSCT populations requires further evaluation.
This clinical trial aims to evaluate the effectiveness of a standardized oral care intervention program for preventing and reducing oral mucositis in pediatric patients undergoing HSCT. The intervention integrates structured oral hygiene management, oral care education, adherence monitoring, and supportive oral management throughout the transplantation process.
The study is designed to provide clinical evidence regarding the role of standardized oral care in improving oral health outcomes and reducing oral mucositis-related complications in pediatric HSCT recipients. The results may contribute to establishing evidence-based oral care protocols and improving supportive care strategies for children undergoing hematopoietic stem cell transplantation.
- Being tested
- Standardized Oral Care Intervention, Routine Oral Care
- Keywords
- Oral mucositis, Hematopoietic stem cell transplantation, Pediatric patients, Oral care, Supportive care
- Medical subject headings
- Stomatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized Oral Care InterventionBehavioural
The intervention consists of standardized oral care procedures, including oral hygiene management, oral care education, oral moisturizing, and compliance monitoring throughout the transplantation period.
Routine Oral CareBehavioural
Participants will receive routine oral care provided according to institutional practice.
| Study group | Role | What they receive |
|---|---|---|
| Standardized Oral Care Intervention Group | Experimental | Participants will receive a standardized oral care intervention during the hematopoietic stem cell transplantation period, including structured oral hygiene management, oral care education, and adherence monitoring. Receives: Behavioral: Standardized Oral Care Intervention |
| Routine Oral Care Group | Active comparator | Participants will receive routine oral care according to the current institutional practice during the hematopoietic stem cell transplantation period. Receives: Behavioral: Routine Oral Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Oral Mucositis
The incidence of oral mucositis will be assessed according to the World Health Organization (WHO) oral mucositis grading criteria. The proportion of participants who develop oral mucositis of grade ≥1 at any time during the observation period from the day of hematopoietic stem cell transplantation (Day 0) through day 30 after transplantation (Day +30) will be compared between the intervention group and the control group.
Measured: From Day 0 to Day +30 after hematopoietic stem cell transplantation
Secondary outcomes (1)
Severity of Oral Mucositis
The severity of oral mucositis will be evaluated according to the WHO oral mucositis grading criteria. The maximum mucositis grade and the proportion of participants who develop moderate to severe oral mucositis (grade ≥3) at any time from Day 0 through Day +30 after hematopoietic stem cell transplantation will be recorded and compared between the intervention group and the control group.
Measured: From Day 0 to Day +30 after hematopoietic stem cell transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Sep 2029 (estimated)
- Study completion1 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Oral MucositisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized, controlled, parallel-group clinical trial. Eligible participants will be randomly assigned in a 1:1 ratio to receive either a standardized oral care intervention or routine oral care. Randomization will be performed using a computer-generated block randomization method with allocation concealment.
- Masking
- None (open label)
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ting Chen, PhD, Principal investigator, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07809451
- Sponsor's protocol ID
- NFEC-2026-634
- Other IDs
- 2025CR019
- Acronym
- SOC-HSCT
- Status last verified
- Sep 2026
- First submitted
- 30 Aug 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because this study involves pediatric hematopoietic stem cell transplantation recipients and includes sensitive clinical information and biological sample-related data. To protect participant privacy and confidentiality, data will be managed and stored according to ethical approval requirements and institutional policies.
Publications
Raber-Durlacher JE, Zadik Y, Treister NS, Stempler N, Bruno JS, Epstein JB, Elad S. MASCC/ISOO clinical practice statement: Current understanding on controversies in basic oral care in hemato-oncology and hematopoietic cell transplantation. Support Care Cancer. 2024 Jul 25;32(8):550. doi: 10.1007/s00520-024-08690-1.
PubMed 39048882Potting CMJ, van Leeuwen SJM, Kurstjens MH, Bronkhorst EM, Thomas RZ, Blijlevens NMA, Huysmans MDNJM. A randomized controlled trial of manual versus powered tooth brushing during haematopoietic stem cell transplantation. Oral Dis. 2022 Oct;28(7):1987-1994. doi: 10.1111/odi.13899. Epub 2021 May 20.
PubMed 33964053de Lima Martins JO, Carlos ACAM, Costa GAJ, Ribeiro RS, Malta CEN, Borges MMF, de Moura JFB, de Arruda LM, Costa FWG, de Barros Silva PG. Oral hygiene protocols reduce the severity and incidence of oral mucositis during antineoplastic treatment: a systematic review and meta-analysis of randomized and non-randomized clinical trials. Support Care Cancer. 2023 Jul 21;31(8):480. doi: 10.1007/s00520-023-07858-5.
PubMed 37477721Agholme MB, Dahllof G, Torlen JK, Majorana A, Brennan MT, von Bultzingslowen I, Tan PL, Hu S, Sim YF, Hong C. Incidence, severity, and temporal development of oral complications in pediatric allogeneic hematopoietic stem cell transplant patients - a multicenter study. Support Care Cancer. 2023 Nov 16;31(12):702. doi: 10.1007/s00520-023-08151-1.
PubMed 37971651Alhussain A, Alkhayal Z, Ayas M, Abed H. Prevalence and risk factors of oral mucositis in paediatric patients undergoing haematopoietic stem cell transplantation. Oral Dis. 2022 Apr;28(3):657-669. doi: 10.1111/odi.13777. Epub 2021 Feb 2.
PubMed 33453145Patel P, Robinson PD, Baggott C, Gibson P, Ljungman G, Massey N, Ottaviani G, Phillips R, Revon-Riviere G, Treister N, White M, Cabral S, Dupuis L, Sung L. Clinical practice guideline for the prevention of oral and oropharyngeal mucositis in pediatric cancer and hematopoietic stem cell transplant patients: 2021 update. Eur J Cancer. 2021 Sep;154:92-101. doi: 10.1016/j.ejca.2021.05.013. Epub 2021 Jul 9.
PubMed 34252760