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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | No Intervention | nutrition counselling plus Standard chemotherapy only. Patients will undergo only standard chemotherapy for 3 months | |
| Group B | Experimental | nutrition counselling plus standard chemotherapy adding oral nutrition supplements as described in manufacturer label daily for 3 month and |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oral nutrition supplement | Dietary Supplement | patients receive ONS 300kcal in daily basis |
|
| 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 .
| 3 MONTHS |
| 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 |
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Inclusion Criteria:
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GI cancer patients will be included in the study if they meet the following criteria:
Exclusion Criteria:
The patients will be excluded from the study if they have the following criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alshaimaa Rabie | Beni-Suef University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beni suef university hospital | Banī Suwayf | Egypt |
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| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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| 6 months |
| common adverse effects | Git toxicity , hematologic toxicity | 6 months |
| D005767 |
| Gastrointestinal Diseases |