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Evaluation of the Effectiveness of Medicinal Combination of Loratadine + Famotidine + Naproxen versus Medicinal Combination of Loratadine + Famotidine + Oxycodone on the Relief of Pegylated Granulocyte Colony Stimulation Factor (Peg-G-CSF)-Induced Bone Pain during Chemotherapy

Evaluation of the Effectiveness of Medicinal Combination of Loratadine + Famotidine + Naproxen versus Medicinal Combination of Loratadine + Famotidine + Oxycodone on the Relief of Pegylated Granulocyte Colony Stimulation Factor (Peg-G-CSF)-Induced Bone Pain during Chemotherapy

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250125064508N1
Enrollment
260
Registered
2025-02-10
Start date
2025-02-03
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Cancer. Agranulocytosis secondary to cancer chemotherapy

Interventions

Intervention 1: Intervention group: Drug combination: Famotidine 40 mg, taken daily, for 3 days in each period + Loratadine 10 mg, taken daily, for 3 days in each period +

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: The patient has a malignant tumor regardless of the type of organ involved, which is a candidate for treatment with pegfilgrastim (PEG-G-CSF) according to the standard chemotherapy protocol and the course of chemotherapy is at least two cycles.

Exclusion criteria

Exclusion criteria: Contraindications for medications in each arm

Design outcomes

Primary

MeasureTime frame
Pain score. Timepoint: The first, second and fourth days in two periods. Method of measurement: Questionnaire (Verbal Numerical Scale).

Secondary

MeasureTime frame
Quality of life. Timepoint: The first, second and fourth days in two periods. Method of measurement: Questionnaire: Fact-BP and EQ-5D.;Adverse events. Timepoint: The first, second and fourth days in two periods. Method of measurement: Common Terminology Criteria for Adverse Events (CTCAE).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactParisa Jalali

Tehran University of Medical Sciences

pjalali@razi.tums.ac.ir+98 933 429 7783

Outcome results

None listed

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