Evaluation of the effect of injectable vitamin B6 and Vitamin C on the reduction of chemotherapy-induced nausea in patients with solid cancer
Design
Quasi-experimental interventional study
Settings and conduct
This study will be conducted on a single group of 44 patients with solid tumors undergoing chemotherapy at Firoozgar Hospital, all of whom will provide informed consent. In this group, during the first chemotherapy cycle, a placebo will be administered six hours prior to chemotherapy infusion, alongside standard antiemetic medications. Both acute nausea (assessed two hours post-infusion) and delayed nausea (assessed 1 to 5 days post-infusion) will be evaluated.
In the same patients, serving as their own controls, prior to the second chemotherapy cycle, 300 mg of Vitamin B6 and 1 g of Vitamin C will be administered intravenously in addition to standard antiemetic medications. Acute nausea (two hours post-infusion) and delayed nausea (1 to 5 days post-infusion) will be assessed again.
Participants/Inclusion and exclusion criteria
Patients with solid cancer under chemotherapy
Intervention groups
Control group:
Patients receive a placebo prior to the first cycle of chemotherapy.
Intervention group:
The same patients receive intravenous Vitamin C and Vitamin B6 prior to the second cycle of chemotherapy.
Main outcome variables
Severity of early and delayed nausea
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20251216068360N1
Registration date:2026-05-06, 1405/02/16
Registration timing:prospective
Last update:2026-05-06, 1405/02/16
Update count:0
Registration date
2026-05-06, 1405/02/16
Registrant information
Name
Ali Mahdi zadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6681 4038
Email address
alimhdzd1999@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-05-17, 1405/02/27
Expected recruitment end date
2027-06-17, 1406/03/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of injectable vitamin B6 and vitamin C on reducing chemotherapy-induced nausea in solid cancer
Public title
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.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
patients with solid cancer who are under chemotherapy
Exclusion criteria:
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)
Age
No age limit
Gender
Both
Phase
4
Groups that have been masked
Participant
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
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.
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of School of Medicine
Street address
Iran University of Medical Sciences (IUMS), Shahid Hemmat Highway, Tehran, IRAN
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2025-05-27, 1404/03/06
Ethics committee reference number
IR.IUMS.FMD.REC.1404.119
Health conditions studied
1
Description of health condition studied
Chemothetrapy induced nausea in solid cancer patients
ICD-10 code
R11
ICD-10 code description
Nausea and vomiting
Primary outcomes
1
Description
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).
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Placebo
2
Description
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.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Firoozgar hospital
Full name of responsible person
Aliarash Anooshirvani
Street address
Firoozgar Hospital, Beh Afarin St., near Valiasr Square, Tehran
City
Tehran
Province
Tehran
Postal code
۱۵۹۳۷۴۸۷۱۱
Phone
+98 21 8214 1795
Email
firoozgar.researchcenter@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
علی امینی
Street address
Office of Vice President for International Affairs, Iran University of Medical Sciences (IUMS), Shahid Hemmat Highway, Tehran, IRAN
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 2503
Email
info@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
دانشگاه علومپزشکی ایران
Full name of responsible person
علی آرش انوشیروانی
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Hematology
Street address
Firoozgar Hospital, Beh Afarin St., near Valiasr Square, Tehran
City
Tehran
Province
Tehran
Postal code
۱۵۹۳۷۴۸۷۱۱
Phone
+98 21 8214 1795
Email
anoshiravani.a@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Aliarash Anooshiravani
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Hematology
Street address
Firoozgar Hospital, Beh Afarin St., near Valiasr Square, Tehran
City
Tehran
Province
Tehran
Postal code
۱۵۹۳۷۴۸۷۱۱
Phone
+98 21 8214 1795
Email
anoshiravani.a@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Ali Mahdi Zadeh
Position
Medical Intern
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
No. 1, Lotifian Alley, Soltani Street, Arab Ahmadi Street, Shahid Bagheri Square, District 18, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1377966319
Phone
+98 21 6681 4038
Email
alimhdzd1999@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available