Clinical Trial Finder
ONS in Gastrointestinal Cancer Patients Undergoing Chemotherapy
Study Purpose
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
Recruitment Criteria
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
Inclusion Criteria:
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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 ONSTrial Details
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
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
Arms
No Intervention: Group A
nutrition counselling plus Standard chemotherapy only. Patients will undergo only standard chemotherapy for 3 months
Experimental: Group B
nutrition counselling plus standard chemotherapy adding oral nutrition supplements as described in manufacturer label daily for 3 month and
Interventions
Dietary Supplement: - oral nutrition supplement
patients receive ONS 300kcal in daily basis
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
International Sites
Status
Recruiting
Address
Beni suef university hospital
Banī Suwayf, ,
Site Contact
Alshaimaa Ibrahim Rabie
[email protected]
01061263030
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