Oral nutrition supplements for GI cancer patients undergoing chemotherapy
The Impact of Oral Nutrition Supplements on the Clinical Outcomes in Gastrointestinal Cancer Patients Undergoing Chemotherapy
NA · Beni-Suef University · NCT05980624
This study tests whether oral nutrition supplements can help people with gastrointestinal cancer feel better and handle chemotherapy better.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Beni-Suef University (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Banī Suwayf) |
| Trial ID | NCT05980624 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of oral nutrition supplements on gastrointestinal cancer patients who are receiving chemotherapy. It aims to improve the prognosis of cancer cachexia, enhance quality of life, and increase tolerance to chemotherapy. The study includes patients with confirmed GI cancer diagnoses at any stage who are undergoing neo/adjuvant chemotherapy. Participants will be monitored for their nutritional intake and overall health status throughout the treatment period.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with a confirmed diagnosis of gastrointestinal cancer who are receiving chemotherapy.
Not a fit: Patients with known hypersensitivity to the investigational compounds or those unlikely to comply with trial requirements may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the health outcomes and quality of life for patients with gastrointestinal cancer undergoing chemotherapy.
How similar studies have performed: Other studies have shown promising results with nutritional interventions in cancer care, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Banī Suwayf
- Beni suef university hospital — Banī Suwayf, Egypt (RECRUITING)
Study contacts
- Principal investigator: Alshaimaa Rabie — Beni-Suef University
- Study coordinator: Alshaimaa Rabie
- Email: alshaimaa.ph@o6u.edu.eg
- Phone: 01061263030
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Gastrointestinal Cancer