Single-dose versus multi-dose Dexamethasone as premedication for Taxane group chemotherapy

Comparing the efficacy of premedication with single-dose versus multi-dose Dexamethasone on adverse events caused by Taxane group chemotherapy in cancer patients

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20230412057889N1

Enrollment

Registered

2024-12-22

Start date

2025-01-01

Completion date

Unknown

Last updated

2025-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chemotherapy adverse events.

Interventions

Intervention 1: Intervention group: Premedication is performed with a single dose of 16 to 24 mg of intravenous dexamethasone 15 to 30 minutes before chemotherapy infusion in each session. Interventio

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Pathological diagnosis of different types of cancer (breast, prostate, ...) Indication of chemotherapy with docetaxel or paclitaxel with a single drug protocol or sequential treatment, including at least three cycles of chemotherapy with an interval of two or three weeks Adequate bone marrow function, including white blood cell count, absolute neutrophil count, and platelet count greater than the lower limit of normal (LLN) according to CTCAE v5.0 Adequate liver function, including bilirubin less than 1.5 times, transaminases less than 2.5 times, and alkaline phosphatase less than 5 times the upper limit of normal (ULN) based on CTCAE v5.0 Adequate kidney function (calculated creatinine clearance greater than 50 ml/min) Good performance status (ECOG = 2)

Exclusion criteria

Exclusion criteria: Pregnancy or breastfeeding Expected survival less than 12 months Uncontrolled hypertension and/or diabetes Edema of any type and with any degree Presence of two or more cancers at the same time Metastatic disease (except bone or distant lymph nodes) Steroid use for other conditions (except prednisolone 10 mg daily in patients with prostate cancer) Chemotherapy with Taxane drugs with weekly protocols and/or combined protocols simultaneously with other chemotherapy drugs Known hypersensitivity reactions to Docetaxel, Paclitaxel, or other chemotherapy drugs and products containing polysorbate 80 and/or chromophore Previous history of anaphylaxis to food, insect bites, medicine, or any other foreign substance

Design outcomes

Primary

Measure	Time frame
Grade 3 and 4 hypersensitivity reactions (HSRs) based on Common Terminology Criteria for Adverse Events (CTCAE) version 5. Timepoint: Every 2 to 3 weeks. Method of measurement: History and physical examination according to table of Common Terminology Criteria for Adverse Events (CTCAE) version 5.;Grade 3 and 4 fluid retention syndrome (FRS) based on Common Terminology Criteria for Adverse Events (CTCAE) version 5. Timepoint: Every 2 to 3 weeks. Method of measurement: History and physical examination according to table of Common Terminology Criteria for Adverse Events (CTCAE) version 5.;Grade 3 and 4 hand-foot syndrome (HFS) based on Common Terminology Criteria for Adverse Events (CTCAE) version 5. Timepoint: Every 2 to 3 weeks. Method of measurement: History and physical examination according to table of Common Terminology Criteria for Adverse Events (CTCAE) version 5.	—

Measure

Time frame

Grade 3 and 4 hypersensitivity reactions (HSRs) based on Common Terminology Criteria for Adverse Events (CTCAE) version 5. Timepoint: Every 2 to 3 weeks. Method of measurement: History and physical examination according to table of Common Terminology Criteria for Adverse Events (CTCAE) version 5.;Grade 3 and 4 fluid retention syndrome (FRS) based on Common Terminology Criteria for Adverse Events (CTCAE) version 5. Timepoint: Every 2 to 3 weeks. Method of measurement: History and physical examination according to table of Common Terminology Criteria for Adverse Events (CTCAE) version 5.;Grade 3 and 4 hand-foot syndrome (HFS) based on Common Terminology Criteria for Adverse Events (CTCAE) version 5. Timepoint: Every 2 to 3 weeks. Method of measurement: History and physical examination according to table of Common Terminology Criteria for Adverse Events (CTCAE) version 5.

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Secondary

Measure	Time frame
All grades hypersensitivity reactions (HSRs) based on Common Terminology Criteria for Adverse Events (CTCAE) version 5. Timepoint: Every 2 to 3 weeks. Method of measurement: History and physical examination according to table of Common Terminology Criteria for Adverse Events (CTCAE) version 5.;All grades fluid retention syndrome (FRS) based on Common Terminology Criteria for Adverse Events (CTCAE) version 5. Timepoint: Every 2 to 3 weeks. Method of measurement: History and physical examination according to table of Common Terminology Criteria for Adverse Events (CTCAE) version 5.;All grades hand-foot syndrome (HFS) based on Common Terminology Criteria for Adverse Events (CTCAE) version 5. Timepoint: Every 2 to 3 weeks. Method of measurement: History and physical examination according to table of Common Terminology Criteria for Adverse Events (CTCAE) version 5.;All grades acute pain syndrome (APS) based on Common Terminology Criteria for Adverse Events (CTCAE) version 5. Timepoint: Every 2 to 3 weeks. Method of measurement: History and physical examination according to table of Common Terminology Criteria for Adverse Events (CTCAE) version 5.;All grades acute dermatitis based on Common Terminology Criteria for Adverse Events (CTCAE) version 5. Timepoint: Every 2 to 3 weeks. Method of measurement: History and physical examination according to table of Common Terminology Criteria for Adverse Events (CTCAE) version 5.;All grades oral mucositis based on Common Terminology Criteria for Adverse Events (CTCAE) version 5. Timepoint: Every 2 to 3 weeks. Method of measurement: History and physical examination according to table of Common Terminology Criteria for Adverse Events (CTCAE) version 5.;All grades nausea based on Common Terminology Criteria for Adverse Events (CTCAE) version 5. Timepoint: Every 2 to 3 weeks. Method of measurement: History and physical examination according to table of Common Terminology Criteria for Adverse Events (CTCAE) version 5.;All grades vomitin	—

Measure

Time frame

All grades hypersensitivity reactions (HSRs) based on Common Terminology Criteria for Adverse Events (CTCAE) version 5. Timepoint: Every 2 to 3 weeks. Method of measurement: History and physical examination according to table of Common Terminology Criteria for Adverse Events (CTCAE) version 5.;All grades fluid retention syndrome (FRS) based on Common Terminology Criteria for Adverse Events (CTCAE) version 5. Timepoint: Every 2 to 3 weeks. Method of measurement: History and physical examination according to table of Common Terminology Criteria for Adverse Events (CTCAE) version 5.;All grades hand-foot syndrome (HFS) based on Common Terminology Criteria for Adverse Events (CTCAE) version 5. Timepoint: Every 2 to 3 weeks. Method of measurement: History and physical examination according to table of Common Terminology Criteria for Adverse Events (CTCAE) version 5.;All grades acute pain syndrome (APS) based on Common Terminology Criteria for Adverse Events (CTCAE) version 5. Timepoint: Every 2 to 3 weeks. Method of measurement: History and physical examination according to table of Common Terminology Criteria for Adverse Events (CTCAE) version 5.;All grades acute dermatitis based on Common Terminology Criteria for Adverse Events (CTCAE) version 5. Timepoint: Every 2 to 3 weeks. Method of measurement: History and physical examination according to table of Common Terminology Criteria for Adverse Events (CTCAE) version 5.;All grades oral mucositis based on Common Terminology Criteria for Adverse Events (CTCAE) version 5. Timepoint: Every 2 to 3 weeks. Method of measurement: History and physical examination according to table of Common Terminology Criteria for Adverse Events (CTCAE) version 5.;All grades nausea based on Common Terminology Criteria for Adverse Events (CTCAE) version 5. Timepoint: Every 2 to 3 weeks. Method of measurement: History and physical examination according to table of Common Terminology Criteria for Adverse Events (CTCAE) version 5.;All grades vomitin

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactSasan Razmjoo

Ahvaz University of Medical Sciences

razmjoo.md@gmail.com+98 61 3374 3057

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026