Back to resultsONS in Gastrointestinal Cancer Patients Undergoing Chemotherapy
Primary Purpose
Gastrointestinal Cancer
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
oral nutrition supplement
Sponsored by
About this trial
This is an interventional supportive care trial for Gastrointestinal Cancer
Eligibility Criteria
Inclusion Criteria: - GI cancer patients will be included in the study if they meet the following criteria: Confirmed cancer diagnosis any stage or metastatic confirmed by radiological and pathological or by clinical evaluation receiving neo/adjuvant chemotherapy treatment. Age above 18 years old Be accessible for chemotherapy treatment and follow-up Availability to administer oral supplements Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2 Life expectancy ≥3 months. Written informed consent according to the local Ethics Committee requirements Willing to fill Nutrition questionnaires. 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: Known hypersensitivity reaction to the investigational compounds or incorporated substances patients who are unlikely to comply with trial requirements (eg, confusion, psychological or mood disturbances ,alcoholism) Pregnancy or lactating 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 Age < 18 years Indication to or ongoing artificial nutrition support (totally compromised spontaneous food-intake) and incapacity or unavailability to consume ONS
Sites / Locations
- Beni suef university hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Group A
Group B
Arm Description
nutrition counselling plus Standard chemotherapy only. Patients will undergo only standard chemotherapy for 3 months
nutrition counselling plus standard chemotherapy adding oral nutrition supplements as described in manufacturer label daily for 3 month and
Outcomes
Primary Outcome Measures
Body Composition
measured by DEXA OR BIA
Anthropometric measures
Body mass index change
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
Secondary Outcome Measures
Laboratory data values mean and standard deviation
Albumin and CRP ,total protein
overall response rate
complete response or progression and regression percentage of participants
common adverse effects
Git toxicity , hematologic toxicity
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05980624
Brief Title
ONS in Gastrointestinal Cancer Patients Undergoing Chemotherapy
Official Title
The Impact of Oral Nutrition Supplements on the Clinical Outcomes in Gastrointestinal Cancer Patients Undergoing Chemotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 20, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
July 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beni-Suef University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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
Detailed 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
No Intervention
Arm Description
nutrition counselling plus Standard chemotherapy only. Patients will undergo only standard chemotherapy for 3 months
Arm Title
Group B
Arm Type
Experimental
Arm Description
nutrition counselling plus standard chemotherapy adding oral nutrition supplements as described in manufacturer label daily for 3 month and
Intervention Type
Dietary Supplement
Intervention Name(s)
oral nutrition supplement
Intervention Description
patients receive ONS 300kcal in daily basis
Primary Outcome Measure Information:
Title
Body Composition
Description
measured by DEXA OR BIA
Time Frame
3 month
Title
Anthropometric measures
Description
Body mass index change
Time Frame
3 month
Title
Nutrition status - scored Patient-Generated Subjective Global Assessment (PG-SGA)
Description
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
Time Frame
3 MONTHS
Secondary Outcome Measure Information:
Title
Laboratory data values mean and standard deviation
Description
Albumin and CRP ,total protein
Time Frame
3 months
Title
overall response rate
Description
complete response or progression and regression percentage of participants
Time Frame
6 months
Title
common adverse effects
Description
Git toxicity , hematologic toxicity
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
-
GI cancer patients will be included in the study if they meet the following criteria:
Confirmed cancer diagnosis any stage or metastatic confirmed by radiological and pathological or by clinical evaluation receiving neo/adjuvant chemotherapy treatment.
Age above 18 years old
Be accessible for chemotherapy treatment and follow-up
Availability to administer oral supplements
Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2
Life expectancy ≥3 months.
Written informed consent according to the local Ethics Committee requirements
Willing to fill Nutrition questionnaires.
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:
Known hypersensitivity reaction to the investigational compounds or incorporated substances
patients who are unlikely to comply with trial requirements (eg, confusion, psychological or mood disturbances ,alcoholism)
Pregnancy or lactating
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
Age < 18 years
Indication to or ongoing artificial nutrition support (totally compromised spontaneous food-intake) and incapacity or unavailability to consume ONS
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alshaimaa Rabie
Phone
01061263030
Email
alshaimaa.ph@o6u.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alshaimaa Rabie
Organizational Affiliation
Beni-Suef University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beni suef university hospital
City
Banī Suwayf
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alshaimaa Ibrahim Rabie
12. IPD Sharing Statement
Plan to Share IPD
No
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ONS in Gastrointestinal Cancer Patients Undergoing Chemotherapy
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