Beni suef university hospital
Banī Suwayf, Egypt
NCT Number: NCT05980624
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
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Phase 2
Banī Suwayf, Egypt
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
-
GI cancer patients will be included in the study if they meet the following criteria:
Exclusion criteria
patients receive ONS 300kcal in daily basis
Time frame: 3 month
measured by DEXA OR BIA
Time frame: 3 month
Body mass index change
Time frame: 3 MONTHS
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 .
Time frame: 3 months
Albumin and CRP ,total protein
Time frame: 6 months
complete response or progression and regression percentage of participants
Time frame: 6 months
Git toxicity , hematologic toxicity
Beni-Suef University
Other
The Impact of Oral Nutrition Supplements on the Clinical Outcomes in Gastrointestinal Cancer Patients Undergoing Chemotherapy
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03958747
Colonic Diseases, Colorectal Cancer
Winston-Salem, North Carolina, United States
View Trial DetailsNCT05664178
Digestive System Diseases, Digestive System Neoplasms
Tampa, Florida, United States
View Trial DetailsNCT06551675
Digestive System Diseases, Digestive System Neoplasms
Hangzhou, Zhejiang, China
View Trial DetailsNCT07405307
Atrophy, Digestive System Diseases
Ljubljana, Slovenia
View Trial Details