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Trial Title:
Percent Weight Change in the Medical Supplement Group of Early Breast Cancer
NCT ID:
NCT06311357
Condition:
Early Stage Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Body Weight Changes
Conditions: Keywords:
Medical supplement
Weight change in early breast cancer treatment
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
Single (Investigator)
Intervention:
Intervention type:
Dietary Supplement
Intervention name:
Ensure
Description:
Ensure 6 scoops dietary supplement powder in 250 ml of water, 2 drinks per days for 12
weeks.
Arm group label:
Intervention
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.
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 drinks/day) 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 0,6,12 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 3.3.0.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Histopathological confirmed diagnosis of breast cancer
- Breast cancer stage I-III
- Recieve adjuvant or neoadjuvant doxorubicin and cyclophosphamide at Rajavithi
hospital
- LVEF >= 60% - ECOG score 0-1
Exclusion Criteria:
- No indication for chemotherapy
- Contraindication for chemotherapy
- Breast cancer stage IV
- Diabetic mellitus who requires insulin injection
- BMI >= 30 kg/m2 or <= 16 kg/m2
- Previously known other malignancies
- Second primary cancer
- Previously received chemotherapy or radiotherapy
- Severe malnutrition with administration of TPN is indicated
- Pregnancy or lactation
- CKD stage 4-5
Gender:
Female
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Rajavithi hospital
Address:
City:
Ratchathewi
Zip:
10400
Country:
Thailand
Status:
Recruiting
Contact:
Last name:
Meitinarth Juntong
Phone:
+66654415447
Email:
juntong.mei@gmail.com
Start date:
July 12, 2023
Completion date:
April 30, 2024
Lead sponsor:
Agency:
Rajavithi Hospital
Agency class:
Other
Source:
Rajavithi Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06311357