Status:
COMPLETED
ONS in Gastrointestinal Cancer Patients Undergoing Chemotherapy
Lead Sponsor:
Beni-Suef University
Conditions:
Gastrointestinal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The study hypothesizes that the addition of oral nutrition supplement concurrent chemotherapy treatment to the GI cancer patients will improve the prognosis of cancer cachexia, improve health state qu...
Detailed Description
Malnutrition is a major public health issue in low- and middle-income countries and forms part of the United Nations 2030 Agenda for Sustainable Development Goals .Cancer is a systemic disease, since ...
Eligibility Criteria
Inclusion
- \-
- GI cancer patients will be included in the study if they meet the following criteria:
- Confirmed cancer diagnosis any stage or metastatic confirmed by radiological and pathological or by clinical evaluation receiving neo/adjuvant chemotherapy treatment.
- Age above 18 years old
- Be accessible for chemotherapy treatment and follow-up
- Availability to administer oral supplements
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2
- Life expectancy ≥3 months.
- Written informed consent according to the local Ethics Committee requirements
- Willing to fill Nutrition questionnaires.
- Negative pregnancy test for pre-menopausal women before inclusion in the trial
Exclusion
- The patients will be excluded from the study if they have the following criteria:
- Known hypersensitivity reaction to the investigational compounds or incorporated substances
- patients who are unlikely to comply with trial requirements (eg, confusion, psychological or mood disturbances ,alcoholism)
- Pregnancy or lactating
- Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent
- Age \< 18 years
- Indication to or ongoing artificial nutrition support (totally compromised spontaneous food-intake) and incapacity or unavailability to consume ONS
Key Trial Info
Start Date :
July 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 16 2025
Estimated Enrollment :
175 Patients enrolled
Trial Details
Trial ID
NCT05980624
Start Date
July 20 2023
End Date
January 16 2025
Last Update
September 19 2025
Active Locations (1)
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1
Beni suef university hospital
Banī Suwayf, Egypt