Clinical Study Evaluating the Effect of Losartan

NCT06539806 | Recruiting DMC

• 1 other identifier: Mona Abd El-Rafea Mohamed
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The pancreas is two organs packaged into one. The islets of Langerhans serve critical endocrine functions, and the exocrine portion is a major source of enzymes that are essential for digestion. Pancreatic cancer (PC) is more commonly referred to as pancreatic infiltrating ductal adenocarcinoma in addition to being the second leading cause of cancer death in the United States, after lung cancer in 2020. Whereas pancreatic cancer is the seventh cause of death from cancer in Asia in 2020. Although it is substantially less common than the other malignancies, pancreatic carcinoma is near the top of the list of killers because it is a highly aggressive carry.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• the patient response rate

  the patient response rate which will be measured using response evaluation criteria in solid tumors (RECIT 1.1).

  one year

Study Arms (2)

Group I (locally advanced PC patients):

ACTIVE COMPARATOR

Including three subset groups (A, B and C) •Group I- A(control group): Fifteen hypertensive patients treated with antihypertensive agent except ARBS and ACEI with locally advanced PC on Folfirinox. • Group I -B (are not treated with ARBs or ACEI prior PC diagnosis): Fifteen hypertensive patients with locally advanced PC and are not treated with ARBs or ACEI before PC diagnosis on the same chemotherapy treatment protocol as the control group in addition to losartan 50 mg once daily for one year after PC diagnosis. • Group I-C (losartan was used for treatment of hypertension before and after PC diagnosis):Fifteen hypertensive patients with locally advanced PC and were treated with losartan one year before PC diagnosis on the same chemotherapy treatment protocol as the control group in addition to losartan 50 mg once daily for one year after PC diagnosis and the dose will be titrated up according to the patient's response.

Drug: Losartan 50mg Tab

Group II (metastatic PC patients):

ACTIVE COMPARATOR

including three subset groups (A, B and C): • Group II-A (control group): Fifteen hypertensive patients treated with antihypertensive agent except ARBS and ACEI with metastatic PC on Gemcitabine hydrochloride 1 gm. vial taken as 1000 mg/m2 IV over 30 min weekly for 7 weeks. • Group II-B (are not treated with ARBs or ACEI prior diagnosis): Fifteen hypertensive patients with metastatic PC and are not treated with ARBs or ACEI before PC diagnosis on the same chemotherapy treatment protocol as the control group in addition to Losartan 50 mg once daily for one year after PC diagnosis. • Group II-C (losartan was used for treatment of hypertension before and after PC diagnosis): Fifteen hypertensive patients with metastatic PC and were treated with losartan one year before PC diagnosis and on the same chemotherapy treatment protocol as the control group in addition to Losartan 50 mg once daily for one year after PC diagnosis

Drug: Losartan 50mg Tab

Interventions

Losartan 50mg Tab DRUG

The efficacy of losartan on response rate in both metastatic and locally advanced pancreatic cancer patients

Also known as: Gemcitabine hydrochloride

Group I (locally advanced PC patients):; Group II (metastatic PC patients):

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female pancreatic cancer patients aged ≥ 50 years old.
• Hypertensive patient with BP ≥ 140/90 mm Hg.
• Histologically confirmed metastatic pancreatic adenocarcinoma; or locally advanced pancreatic cancer patients.
• All included patients must sign an informed consent

You may not qualify if:

• Patients with serious concomitant systemic disorders as significant cardiac, renal, hepatic, or pulmonary morbidity.
• Pregnant or lactating women and women of childbearing potential.
• Patients received prior systemic fluoropyrimidine therapy within the past 10 years.
• Prior un-anticipated severe reaction to fluoropyrimidine therapy, or known hypersensitivity to 5-fluorouracil, irinotecan, oxaliplatin, losartan, or any monoclonal antibody.
• Patients with an active, known, or suspected autoimmune disease such as psoriasis.
• Patients with a known positive test for hepatitis B virus surface antigen (HBV s Ag) or hepatitis C virus (HCV antibody) and patients with a known history of testing positive for (HIV) or known acquired immunodeficiency syndrome (AIDS).
• Patients received a live vaccine or live attenuated vaccines as intranasal influenza vaccines within 30 days of the planned start of study therapy.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University Hospital

Tanta, Egypt

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Losartan; Gemcitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrazoles; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines

Study Officials

• Osama Mohamed Hassan, Professor

  Clinical Pharmacy Department Faculty of Pharmacy, Tanta University

  STUDY DIRECTOR

• Sahar Mohamed El-Ghobashy, Professor

  Clinical Pharmacy Department Faculty of Pharmacy, Tanta University

  STUDY DIRECTOR

• Mohamed Abdel Hamid Mohamed, Professor

  Clinical Oncology Faculty of Medicine, Tanta University

  STUDY CHAIR

Central Study Contacts

Mona Abd El-Rafea Mohamed, M.D

CONTACT

+201150232022; drmona.abdo14@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer of Clinical Pharmacy

Study Record Dates

• First Submitted: July 18, 2024
• First Posted: August 6, 2024
• Study Start: July 20, 2024
• Primary Completion (Estimated): August 10, 2026
• Study Completion (Estimated): August 20, 2026
• Last Updated: August 6, 2024

Record last verified: 2024-07

Locations

EG (1)