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| ID | Type | Description | Link |
|---|---|---|---|
| IRCT20140818018842N42 | Registry Identifier | Iranian Registry of Clinical Trials |
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| Name | Class |
|---|---|
| Research Institute for Oncology- Hematology and Cell Therapy (RIOHCT), Tehran University of Medical Sciences, Iran | UNKNOWN |
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Oral mucositis (OM) is one of the most frequent complications in patients who undergo HSCT. It not only causes severe discomfort but also affects treatment adherence and increases hospital stays. In this study, we aim to assess whether using N-acetylcysteine mouthwash can safely and effectively prevent OM. The trial is randomized and conducted in the hematology wards of TUMS-affiliated RIOHCT, including both autologous and allogeneic HSCT patients.
This randomized, double-blind, placebo-controlled clinical trial evaluates the safety and efficacy of N-acetylcysteine (NAC) mouthwash in preventing oral mucositis (OM) in patients undergoing hematopoietic stem cell transplantation (HSCT). Oral mucositis is one of the most common and severe complications following HSCT, significantly affecting patient quality of life, treatment adherence, and duration of hospitalization.
A total of 100 patients undergoing autologous or allogeneic HSCT were enrolled and randomly assigned into two parallel groups: an intervention group and a placebo group. The intervention group received 2400 mg of N-acetylcysteine daily as a mouthwash, while the control group received a placebo mouthwash with identical appearance and administration protocol. Both patients and healthcare providers were blinded to group allocation.
The study was conducted at the Research Institute of Oncology, Hematology, and Cell Therapy (RIOHCT), located in Shariati Hospital and affiliated with Tehran University of Medical Sciences. Daily evaluations for the incidence and severity of mucositis were performed using the World Health Organization (WHO) mucositis grading scale.
The primary objective is to assess the efficacy of prophylactic NAC mouthwash in reducing the incidence and severity of OM, particularly grades 3 and 4. Secondary objectives include examining the effect of NAC mouthwash on hospitalization length after engraftment and determining the safety profile of the intervention. Findings from this study may support the introduction of NAC mouthwash as a preventive strategy against mucositis in HSCT patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| N-Acetylcysteine group | Experimental | Participants in this group receive 2400 mg of N-acetylcysteine daily as an oral mouthwash, divided into four doses per day. The intervention starts at the beginning of the conditioning regimen and continues until day 14 after hematopoietic stem cell transplantation. |
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| Placebo group | Placebo Comparator | Participants in this group receive a placebo mouthwash with identical appearance, taste, and administration schedule as the NAC mouthwash. The placebo contains no active pharmaceutical ingredients and is administered four times daily from the start of conditioning until day 14 post-transplantation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| N-Acetylcysteine 600mg/tab | Drug | Each dose consists of one 600 mg effervescent tablet of N-acetylcysteine (NAC) dissolved in 20 mL of sodium carbonate solution. Participants receive this mouthwash four times daily, totaling 2400 mg of NAC per day. The solution is used as an oral rinse (swish and spit) and is not intended to be swallowed. Administration begins with the conditioning regimen and continues until day 14 after HSCT. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of oral mucositis | Oral mucositis is a painful and debilitating complication of hematopoietic stem cell transplantation, characterized by erythema, edema, and ulcerations of the oral mucosa. The incidence of mucositis is assessed daily from the beginning of the conditioning regimen until day +14 post-transplantation. The World Health Organization (WHO) Oral Toxicity Scale is used to grade the severity of mucositis. The presence of grade ≥1 mucositis is recorded as incidence. | From day 1 of conditioning to day +14 post-transplantation. |
| Incidence of N-acetylcysteine-related Adverse Events | Participants are monitored daily for any adverse events potentially related to the use of N-acetylcysteine mouthwash. Adverse events include non-immune anaphylaxis reactions, cardiovascular reactions, dermatologic reactions (such as rash or pruritus), and gastrointestinal reactions (such as nausea or vomiting). | Clinical examination is performed daily from the beginning of the conditioning regimen until day +14 post-transplantation. |
| Incidence of Severe Oral Mucositis | Severe oral mucositis is defined as grade 3 or 4 according to the World Health Organization (WHO) Oral Toxicity Scale. Participants are assessed daily to determine the presence and severity of mucositis. The incidence of severe mucositis (grade ≥3) is recorded during the study period. | From day 1 of conditioning to day +14 post-transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Hospitalization | The number of days from admission for hematopoietic stem cell transplantation until hospital discharge. Data are obtained from the patients' medical records. This outcome reflects overall clinical recovery and is used to evaluate the potential supportive effect of N-acetylcysteine on hospitalization duration. | From hospital admission through hospital discharge, up to Day +60 post-transplantation |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Institute of Oncology, Hematology, and Cell Therapy, Shariati Hospital | Tehran | Iran |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24614837 | Background | Moslehi A, Taghizadeh-Ghehi M, Gholami K, Hadjibabaie M, Jahangard-Rafsanjani Z, Sarayani A, Javadi M, Esfandbod M, Ghavamzadeh A. N-acetyl cysteine for prevention of oral mucositis in hematopoietic SCT: a double-blind, randomized, placebo-controlled trial. Bone Marrow Transplant. 2014 Jun;49(6):818-23. doi: 10.1038/bmt.2014.34. Epub 2014 Mar 10. |
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| ID | Term |
|---|---|
| D013280 | Stomatitis |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D000111 | Acetylcysteine |
| ID | Term |
|---|---|
| D003545 | Cysteine |
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Placebo | Drug | Each dose consists of one placebo effervescent tablet, identical in appearance and packaging to the N-acetylcysteine tablets, dissolved in 20 mL of sodium carbonate solution. Participants use this placebo mouthwash four times daily as an oral rinse (swish and spit), starting from the conditioning regimen and continuing until day 14 post-transplantation. The placebo contains no active pharmaceutical ingredients. |
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| D000596 |
| Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |