ONS in Gastrointestinal Cancer Patients Undergoing Chemotherapy

Trial Title: ONS in Gastrointestinal Cancer Patients Undergoing Chemotherapy

NCT ID: NCT05980624

Condition: Gastrointestinal Cancer

Conditions: Official terms:
Gastrointestinal Neoplasms

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Supportive Care

Masking: None (Open Label)

Intervention:

Intervention type: Dietary Supplement
Intervention name: oral nutrition supplement
Description: patients receive ONS 300kcal in daily basis
Arm group label: Group B

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 quality of life and increase chemotherapy tolerance

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 even in the early stages malignancies are accompanied by homeostatic imbalance, including metabolic deregulation and increased catabolism. These abnormalities may initially seem poorly discernible in the clinic, but with disease progression they may aggravate; and may cause overt cancer-related cachexia.GI cancers show higher mortality than any other kind of cancer. In 2020, they accounted for an estimated 3.5 million deaths worldwide, with a further 5.0 million new cases diagnosed in the same year . Colorectal cancer (CRC) is the most common type of GI cancer, being the third most common of all organ cancers after lung and breast cancers, whereas gastric, liver, esophageal, and pancreatic cancers are ranked the fifth, sixth, eighth, and 12th most commonly diagnosed cancers, respectively

Criteria for eligibility:
Criteria:
Inclusion Criteria: - GI cancer patients will be included in the study if they meet the following criteria: 1. Confirmed cancer diagnosis any stage or metastatic confirmed by radiological and pathological or by clinical evaluation receiving neo/adjuvant chemotherapy treatment. 2. Age above 18 years old 3. Be accessible for chemotherapy treatment and follow-up 4. Availability to administer oral supplements 5. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2 6. Life expectancy ≥3 months. 7. Written informed consent according to the local Ethics Committee requirements 8. Willing to fill Nutrition questionnaires. 9. Negative pregnancy test for pre-menopausal women before inclusion in the trial Exclusion Criteria: - The patients will be excluded from the study if they have the following criteria: 1. Known hypersensitivity reaction to the investigational compounds or incorporated substances 2. patients who are unlikely to comply with trial requirements (eg, confusion, psychological or mood disturbances ,alcoholism) 3. Pregnancy or lactating 4. 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 5. Age < 18 years 6. Indication to or ongoing artificial nutrition support (totally compromised spontaneous food-intake) and incapacity or unavailability to consume ONS

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Beni suef university hospital

Address:
City: Banī Suwayf
Country: Egypt

Status: Recruiting

Contact:
Last name: Alshaimaa Ibrahim Rabie

Start date: July 20, 2023

Completion date: December 2024

Lead sponsor:
Agency: Beni-Suef University
Agency class: Other

Source: Beni-Suef University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05980624