ONS in Gastrointestinal Cancer Patients Undergoing Chemotherapy

Gastrointestinal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05980624
• Other study ID #: FMBSUREC/09072023/Rabie
• Status: Recruiting
• Phase: N/A
• Start date: July 20, 2023
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Beni-Suef University
• Contact: Alshaimaa Rabie
• Phone: 01061263030
• Email: alshaimaa.ph[@]o6u.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: December 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastrointestinal Cancer
• Gastrointestinal Neoplasms

Intervention

Dietary Supplement:
• oral nutrition supplement
patients receive ONS 300kcal in daily basis

Locations

Country	Name	City	State
Egypt	Beni suef university hospital	Bani Suwayf

Sponsors (1)

Lead Sponsor	Collaborator
Beni-Suef University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Composition	measured by DEXA OR BIA	3 month
Primary	Anthropometric measures	Body mass index change	3 month
Primary	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	Laboratory data values mean and standard deviation	Albumin and CRP ,total protein	3 months
Secondary	overall response rate	complete response or progression and regression percentage of participants	6 months
Secondary	common adverse effects	Git toxicity , hematologic toxicity	6 months