NCT06311357

Percent Weight Change in the Medical Supplement Group of Early Breast Cancer

Effects of Body Weight Change in the Medical Supplement Group in Patients With Early Breast Cancer During Chemotherapy: a Randomized, Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Department of Medical Services Ministry of Public Health of Thailand · Other Government
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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.

Conditions

• Early Stage Breast Cancer

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Ensure	Ensure 6 scoops dietary supplement powder in 250 ml of water, 2 drinks per days for 12 weeks.

Timeline

• Start date: 2023-07-12
• Primary completion: 2024-04-26
• Completion: 2024-12-30
• First posted: 2024-03-15
• Last updated: 2024-12-27

Locations

1 site across 1 country: Thailand