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Clinical Trial

Clinical Trial 2022 -2023

Clinical Trial in the Breast cancer Program

Dr.Amal Al-Fahdi. Holistic Care

Psycho-education and Anxiety/Depression- Effect of psycho-educational intervention to reduce anxiety and depression in newly diagnosed breast cancer patient. 

The aim of this study is to investigate the effectiveness of psychoeducation intervention, which aims to improve the quality of life and reduce anxiety and depression levels among women with BC. Methods: It is an experimental design with two groups (Intervention: psycho-education vs. Control: usual care) of a total of 332 BC patients (n=166 per group) who are newly diagnosed, with an age range from 18 to 60 years. After their first appointment, patients will be recruited from Sultan Qaboos Comprehensive Cancer Centre (SQCCCRC) and Royal Hospital (RH). Assessment will be done twice for both groups using different tools such as Hospital Anxiety and Depression Scale (HADS) and Edmonton Symptom Assessment System (ESAS). Future benefits: The findings of this study will provide new options likely to benefit women diagnosed with BC in care settings. As such, psycho-education services should be prioritized for BC patients.

Clinical Trial in the Gastrointestinal Cancers Program

Prof. Mansour Al Moundhri. Medical Oncology

IMREAL / MO40653- Non-interventional trial to investigate outcomes and safety of Atezoluzimab under real worlds conditions in patients treated in routine clinical practice.

The purpose of this phase IV observational study is to see how the treatment with atezolizumab works in “real life” in the context of routine medical practice aiming at assessing the outcomes, clinical benefit, and safety of this drug in patients treated for selected approved indications. Moreover, with this study additional safety information can be obtained, i.e., information about how well the drug is tolerated by patients when prescribed in routine medical practice.

Clinical Trial in the Gynecological Cancers Program

 Dr. Khadra Ahmed Galaal.Surgical Oncology

Self-Sampling Study for HPV- Self-sampling for cervical cancer screening in Women in Oman.

Cervical cancer is a common cancer affecting women. It occurs in the mouth of the womb but can spread to other organs. It is caused by a viral infection and the agent is called HPV. This disease has a long period when it is a pre-cancer and is therefore without symptoms.
This pre-cancer can be detected by various methods such as )Visual Inspection with acetic Acid) VIA, Pap smear or HPV test. Early detection of cancer will lead to cure in over 90 % of cases by simple procedures. However, if detected late, treatment of cancer is costly, difficult, can have side effects and not very successful.
Women do not see a gynecologist and have screening tests for many reasons: inconvenience, embarrassment, fear and, commitments at home or in the work place. If women can provide a sample such as urine or a vaginal swab by themselves, they may be willing to undergo screening. We are conducting a study on cancer screening. This project is to see if women in Oman can provide an adequate sample for HPV testing and whether this test compares with the traditional cervical sample taken by a doctor.

Clinical Trials for multiple programs

Dr. Airton Leonardo Manoel. ICU

MEGA-ROX- A Protocol for multiple parallel multi-centre, randomized, single blinded clinical trials comparing conservative vs. liberal oxygenation targets in mechanically ventilated adults in the intensive care unit nested within a single 40,000 patient mega trial.

The purpose of the Mega-ROX study is to determine the effect of two approaches to oxygen therapy on the risk of death in patients who need emergency life support (a breathing machine) in the ICU.

SPICE IV- Sedation Practice in Intensive Care Evaluation SPICE IV Early Sedation with Dexmedetomidine vs. Placebo in Older Ventilated Critically Ill Patients A Prospective, Multi-Centre, Double-Blind, Randomized, Controlled Trial. 

The research project is evaluating a treatment for sedation of patients which is often used in ICU but typically is used late in the ICU stay. The treatment is called dexmedetomidine (Dexmedetomidine Ever Pharma). The purpose of this study is to evaluate a sedative drug, dexmedetomidine that might improve survival and recovery (reduce delirium, time on a ventilator and time in ICU) for older patients who require sedation in ICU.

SODA-BIC- SODium BICarbonate for Metabolic Acidosis in the Intensive Care Unit (SODa-BIC): A multicentre, randomised, double-blind clinical trial. (Will activate soon).

This trial aims to assess if, among adults in the ICU with metabolic acidosis and receiving vasopressor, an infusion of sodium bicarbonate diluted in 5% dextrose, compared with an infusion of 5% dextrose, reduces Major Adverse Kidney Events within 30 days of randomization.

Bushra Salman. Pharmacy

FP-PK-PG Trial- Effect of Molecular Markers on Fluorouracil and Capecitabine Pharmacokinetics and Clinical Outcomes.  

The fluoropyrimidine (FP) chemotherapeutic agents’ 5-fluorouracil (5-FU) and capecitabine (CAP) are cornerstone in the management of a number of solid tumors. Efficacy, which is how well the medication works, is comparable between these agents, but toxicity, the bad side effects, differs. We hope that the result of our study will add to our understanding of the significant genetic markers which affect the metabolism of these drugs among Omanis. The benefits of this study to the individual is proactive screening of all simple or significant side effects, if occurred and prompt management.