ONS in Gastrointestinal Cancer Patients Undergoing Chemotherapy

Study Overview
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Brief Summary
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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
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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

Official Title
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The Impact of Oral Nutrition Supplements on the Clinical Outcomes in Gastrointestinal Cancer Patients Undergoing Chemotherapy

Conditions
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Gastrointestinal Cancer

Intervention / Treatment
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* Dietary Supplement: oral nutrition supplement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Group A<br>nutrition counselling plus Standard chemotherapy only. Patients will undergo only standard chemotherapy for 3 months | |
| Experimental: Group B<br>nutrition counselling plus standard chemotherapy adding oral nutrition supplements as described in manufacturer label daily for 3 month and | Dietary Supplement: oral nutrition supplement<br>* patients receive ONS 300kcal in daily basis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Composition | measured by DEXA OR BIA | 3 month | 
| Anthropometric measures | Body mass index change | 3 month | 
| Nutrition status - scored Patient-Generated Subjective Global Assessment (PG-SGA) | malnutrition assessment tool. ( 0-1 )No intervention required at this time. Re-assessment on routine and regular basis during treatment. (2-3) Patient & family education by dietitian, nurse, or other clinician with pharmacologic intervention as indicated by symptom survey and lab values as appropriate. (4-8) Requires intervention by dietitian, in conjunction with nurse or physician as indicated by symptoms . 9 Indicates a critical need for improved symptom management and/or nutrient intervention options | 3 MONTHS | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Laboratory data values mean and standard deviation | Albumin and CRP ,total protein | 3 months | 
| overall response rate | complete response or progression and regression percentage of participants | 6 months | 
| common adverse effects | Git toxicity , hematologic toxicity | 6 months |