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IRCT20251216068360N1 IRCT 2026-05-06 Iran University of Medical Sciences Evaluation of the effect of injectable vitamin B6 and vitamin C on reducing chemotherapy-induced nausea in solid cancer patients referred to Firoozgar Hospital in 2025. Evaluation of the effect of injectable vitamin B6 and vitamin C on reducing chemotherapy-induced nausea in solid cancer 2026-05-17 anticipated 42 Recruiting https://irct.ir/trial/88143 interventional Randomization: Not randomized, Blinding: Single blinded, Placebo: Used, Assignment: Crossover, Purpose: Supportive, Blinding description: This study is conducted using a single-blind design. The participants are blinded to their allocation into the intervention and control groups, while the investigators are aware of the assigned interventions. Group allocation is carried out using coded labels, and information regarding group assignment is withheld from participants until the completion of outcome assessment. 4 Chemothetrapy induced nausea in solid cancer patients. Intervention 1: Intervention group: Injection of placebo 6 hours before first cycle of chemotherapy beside other usual Antiemetics and evaluation of early and delayed nausea in all patients. Intervention 2: Control group: Injection of 300mg Vitamin B6 and 1gr Vitamin C IV beside other usual antiemetics and evaluation of early and delayed nausea in the same patients. 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 No further information is available.
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Firoozgar Hospital, Beh Afarin St., near Valiasr Square, Tehran
Tehran Iran (Islamic Republic of) ۱۵۹۳۷۴۸۷۱۱ +98 21 8214 1795 anoshiravani.a@iums.ac.ir دانشگاه علوم‌پزشکی ایران scientific Aliarash Anooshiravani
Firoozgar Hospital, Beh Afarin St., near Valiasr Square, Tehran
Tehran Iran (Islamic Republic of) ۱۵۹۳۷۴۸۷۱۱ +98 21 8214 1795 anoshiravani.a@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) patients with solid cancer who are under chemotherapy no limit no limit Both Known hypersensitivity or allergic reaction to Vitamin B6 or Vitamin C Any change in chemotherapy regimen between the first and second cycles Severe renal impairment (eGFR < 30 mL/min/1.73 m²) or history of recurrent nephrolithiasis Severe hepatic impairment Concurrent use of non-standard antiemetic regimens or high-dose vitamin supplements Pregnancy or breastfeeding Symptomatic brain metastases or other causes of nausea and vomiting unrelated to chemotherapy Uncontrolled nausea and vomiting prior to initiation of the study (baseline instability) R11 Nausea and vomiting Placebo Treatment - Drugs Intervention group: Injection of placebo 6 hours before first cycle of chemotherapy beside other usual Antiemetics and evaluation of early and delayed nausea in all patients. Control group: Injection of 300mg Vitamin B6 and 1gr Vitamin C IV beside other usual antiemetics and evaluation of early and delayed nausea in the same patients. Severity of chemotherapy induced nausea on the basis of MAT Questionnaire. Timepoint: 24 hours and 72 hours after intervention. Method of measurement: by the use of The Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool (MAT). Iran University of Medical Sciences Approved 2025-05-27 Research Ethics Committees of School of Medicine Iran University of Medical Sciences (IUMS), Shahid Hemmat Highway, Tehran, IRAN Tehran Tehran Iran (Islamic Republic of)