Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06311357
Status:
RECRUITING
Last Update Posted:
2024-03-15
First Post:
2023-12-12
Brief Title:
Percent Weight Change in the Medical Supplement Group of Early Breast Cancer
Sponsor:
Rajavithi Hospital
Organization:
Rajavithi Hospital
Study Overview
Official Title:
Effects of Body Weight Change in the Medical Supplement Group in Patients With Early Breast Cancer During Chemotherapy a Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this RCT is to compare percent weight change in early breast cancer who takes medical supplement or not during treatment with chemotherapy standard AC regimen
The main question is
the change of weight before and after complete treatment of breast cancer therapy
Participants will be randomized into 2 group
intervention group - receive medical supplement daily during chemotherapy treatment
control group - Nutritional advise during chemotherapy treatment
The main question is
the change of weight before and after complete treatment of breast cancer therapy
Participants will be randomized into 2 group
intervention group - receive medical supplement daily during chemotherapy treatment
control group - Nutritional advise during chemotherapy treatment
Detailed Description:
1 The rational is to prove the hypothesis is that the effect of medical supplement with nutritional advise can prevent the reduction of body weight malnutrition and treatment complication which eventually to improve of the quality of life
2 Primary endpoint of the study is to compare the effect of medical supplement on percent weight change in early breast cancer who received chemotherapy in Rajavithi hospital Secondary endpoints are nutritional status PG-SGA quality of life
3 Sample size formula based on Bernard R Fundamentals of biostatistics 5th ed Duxbery Thomson learning 2000 Enrollment of 40 patients
4 Randomization into 2 groups Intervention arm receive medical supplement daily 1 drink 6 scoops in 250 ml water 2 drinksday with nutritional advise Control arm nutritional advise only Duration of treatment is 12 weeks
5 Enrollment and data monitoring is assessed by the staffs of oncology department in Rajavithi hospital and the data will be recorded in computer based information system
6 Data assessment on week 0612 during chemotherapy treatment
7 Data analyzed by descriptive statistics to characterize patients at entry We did the efficacy analyses with intention to treat population
8 We did analyses with R version 330
2 Primary endpoint of the study is to compare the effect of medical supplement on percent weight change in early breast cancer who received chemotherapy in Rajavithi hospital Secondary endpoints are nutritional status PG-SGA quality of life
3 Sample size formula based on Bernard R Fundamentals of biostatistics 5th ed Duxbery Thomson learning 2000 Enrollment of 40 patients
4 Randomization into 2 groups Intervention arm receive medical supplement daily 1 drink 6 scoops in 250 ml water 2 drinksday with nutritional advise Control arm nutritional advise only Duration of treatment is 12 weeks
5 Enrollment and data monitoring is assessed by the staffs of oncology department in Rajavithi hospital and the data will be recorded in computer based information system
6 Data assessment on week 0612 during chemotherapy treatment
7 Data analyzed by descriptive statistics to characterize patients at entry We did the efficacy analyses with intention to treat population
8 We did analyses with R version 330
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None