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IRCT20260908070968N1 IRCT 2026-10-01 Semnan University of Medical Sciences Evaluating the effect of oxygen therapy during Chemotherapy on the prevention of Chemotherapy-Induced oral sores and Inflammation in patients with colorectal cancer Determining the effect of oxygen therapy during chemotherapy on 5FU-induced oral mucositis in colorectal cancer patients treated with FOLFOX regimen: A double-blind clinical trial 2026-10-23 anticipated 20 Recruiting https://irct.ir/trial/93130 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Diagnostic, Randomization description: Patients will be randomly allocated to the intervention or control group using block randomization with blocks of two, generated through the Sealed Envelope website. Randomization will be stratified by sex, and patients will be equally allocated to the two study groups, Blinding description: In this study, participants and the data analyst will be blinded to group allocation. Participants will receive the intervention individually in separate rooms and will not have the opportunity to observe the intervention received by other participants. Information regarding group allocation and the type of intervention will not be disclosed to the participants. In the intervention group, oxygen therapy will be administered via a simple face mask for 30 minutes, while participants in the control group will remain under usual conditions and breathe room air. The intervention will be administered separately to each participant to minimize the possibility of revealing group allocation through observation of other participants. The personnel responsible for administering the intervention and the outcome assessor will not be blinded due to the nature of the intervention and the assessment process. For blinding of the data analyst, participant data will be coded using non-identifiable group codes (e.g., A and B) before statistical analysis. The code key will be kept by the principal investigator until completion of the statistical analysis. Therefore, the data analyst will not know which code represents the intervention or control group during the analysis. The group allocation codes will be revealed after completion of the statistical analysis. N/A Colorectal cancer. Intervention 1: Intervention group: Patients will receive oxygen therapy via a simple face mask at 2 L/min for 30 minutes concurrently with the 5-FU bolus during each chemotherapy session. Oral mucositis severity will be assessed using the OMAS before the intervention and after every two chemotherapy sessions. Intervention 2: Control group: Patients will breathe room air normally without oxygen therapy or a mask during 5-FU bolus administration. Oral mucositis severity will be assessed using OMAS before treatment and after every two chemotherapy sessions. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information available.
public Elham Sadat Afraz
School of Dentistry, 17 Shahrivar Blvd.
Semnan Iran (Islamic Republic of) 3518794431 +98 23 3332 4700 eafraz@gmail.com Semnan University of Medical Sciences scientific Elham Sadat Afraz
School of Dentistry, 17 Shahrivar Blvd.
Semnan Iran (Islamic Republic of) 3518794431 +98 23 3332 4700 eafraz@gmail.com Semnan University of Medical Sciences Iran (Islamic Republic of) Patients with a confirmed diagnosis of non-metastatic colorectal cancer, (based on medical records and confirmation by an oncologist) Receiving the FOLFOX chemotherapy regimen, including 5-fluorouracil (5-FU) administered as a bolus injection. Normal baseline blood oxygenation, defined as SpO₂ > 92% on room air. Ability to fully cooperate with the research team and attend treatment and follow-up sessions regularly. 18 years 75 years Both History of hypersensitivity or intolerance to oxygen therapy. Presence of severe chronic pulmonary diseases, such as advanced chronic obstructive pulmonary disease (COPD) or uncontrolled asthma. Presence of active oral infection or chronic oral and dental diseases that could affect the assessment of oral mucositis severity. Concurrent receipt of radiotherapy to the head and neck region. Severe renal or hepatic insufficiency. Active psychiatric illness or cognitive impairment that may interfere with adequate understanding of the study procedures and informed consent. Participation in another clinical trial within the previous three months. Voluntary withdrawal from the study at any stage or failure to cooperate with the follow-up procedures. C18 Malignant neoplasm of colon N/A N/A Intervention group: Patients will receive oxygen therapy via a simple face mask at 2 L/min for 30 minutes concurrently with the 5-FU bolus during each chemotherapy session. Oral mucositis severity will be assessed using the OMAS before the intervention and after every two chemotherapy sessions. Control group: Patients will breathe room air normally without oxygen therapy or a mask during 5-FU bolus administration. Oral mucositis severity will be assessed using OMAS before treatment and after every two chemotherapy sessions. Oral Mucositis Severity Score. Timepoint: Before the intervention and after every two chemotherapy sessions. Method of measurement: Oral Mucositis Assessment Scale. Semnan University of Medical Sciences Approved 2026-06-22 Ethics Committees of Semnan University Of Medical Central Headquarters, Semnan University of Medical Sciences, Basij Blvd. Semnan Semnan Iran (Islamic Republic of)