Status:
COMPLETED
Comparison Between Mirtazapine and Megestrol for the Control of Anorexia-cachexia in Cancer Patients in Palliative Care.
Lead Sponsor:
University of Sao Paulo
Conditions:
Cachexia; Cancer
Anorexia
Eligibility:
All Genders
50+ years
Phase:
PHASE2
Brief Summary
Cancer-associated anorexia-cachexia is an insidious syndrome that has a major impact on the patient's quality of life, but is also associated with a significant reduction in survival. Despite its clin...
Detailed Description
Cancer-associated anorexia-cachexia is an insidious syndrome that has a major impact on the patient's quality of life, but is also associated with a significant reduction in survival. Unintentional we...
Eligibility Criteria
Inclusion
- Patients aged ≥ 50 years.
- Patients with confirmed diagnosis of cancer by histopathological examination, including those not yet submitted to any therapy because they are in the therapeutic definition phase and those whose therapies have already been suspended because they are ineffective.
- Patients with cancer progression, with either local or distant metastases, documented by radiological or histopathological methods.
- Patients complaining of anorexia graded by the patient as ≥ 5 by the Edmonton Sympton Assessement Scale.
- Patients with weight loss ≥ 2% in the last 2 months or weight loss ≥ 5% in the last 6 months, referred by the patient or documented in electronic medical records, compared to the stable weight before diagnosis.
- Patients with a life expectancy of ≥ 2 months by the Palliative Prognostic Score.
- Patients with performance status greater than or equal to 60% using the Karnofsky Performance Status scale.
Exclusion
- Patients diagnosed with depression or using antidepressant therapy with a score ≥ 12 in the depression items of the Hospital Anxiety and Depression Scale.
- Patients with unstable doses of corticosteroids.
- Patients with moderate renal and/or hepatic dysfunction (total bilirubin ≥ 1.5x the upper limit of normal, AST and ALT ≥ 5x upper limit of normal or creatinine ≥1.5x upper limit of normal).
- Patients with Central Nervous System metastases.
- Patients with inability to take oral medications.
- Patients with mechanical obstruction of the gastrointestinal tract.
- Patients with clinically bulky ascites and generalized edema.
- Patients with reports of allergy to the medications studied.
- Patients with hypothyroidism with TSH levels greater than or equal to 5 μU/mL and free T4 less than 0.7 ng/dL.
- Patients with uncorrected hydroelectrolytic disturbances, with altered serum sodium, potassium and/ or ionic calcium.
- Patients with persistent and uncontrolled nausea and/or vomiting associated with gastrointestinal tract neoplasia and/or chemotherapeutic or radiotherapeutic treatment.
- Patients with pacemakers.
Key Trial Info
Start Date :
March 26 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 2 2022
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT03283488
Start Date
March 26 2019
End Date
February 2 2022
Last Update
July 7 2023
Active Locations (1)
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1
Clinics Hospital, Ribeirão Preto Medical School, University of São Paulo
Ribeirão Preto, São Paulo, Brazil, 14048900