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Trigonella, Foeniculum, Chichorium in prevention of cancer-induced cachexia/anorexia

Phase 3
Conditions
Cancer-induced cachexia.
Malignant neoplasm without specification of site
Registration Number
IRCT20180722040556N2
Lead Sponsor
Esfahan University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
60
Inclusion Criteria

All adult patients (18 years and older) with advanced solid malignant tumour (Stage 3-4) who encountered cancer-induced anorexia or weight loss (equal or greater than 5% of the previous weight before cancer diagnosis or within the last two months). Cancer patients with serum creatinine < 2 mg /dl and serum total bilirubin < 2 mg /dl. Patients should not have any sign of dysphagia or gastrointestinal obstruction. The patients' life expectancy should be at least 3 months. Patients who are taking high doses of megestrol due to cachexia and anorexia simultaneously.

Exclusion Criteria

Patients who have undergone major surgery during the last 4 weeks.
Patients with a history of thrombophlebitis diseases.
Patients who have been taking systemic corticosteroid within the last 4 weeks or concurrently.
Patients who have cognitive impairment, psychiatric disorder or brain metastasis leading to cognitive impairment.
Patients who have diabetes, uncontrolled blood pressure or advanced heart failure (NYHA 4)
Patients who are alcoholic.
Patients who are pregnant or breast-feeding.
Patients with a known hypersensitivity reaction to one of the plants in study herbal combination.

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Cachexia/anorexia. Timepoint: Baseline and 8 weeks later. Method of measurement: Edmonton criteria.
Secondary Outcome Measures
NameTimeMethod
Quality of life. Timepoint: Baseline and eight weeks later. Method of measurement: Iranian Version of the EORTC QLQ.
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