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

Rajavithi Hospital

Status: Enrolling

Conditions: Early Stage Breast Cancer

Treatments: Dietary Supplement: Ensure

Study type: Interventional

Funder types: Other

Identifiers

NCT06311357

100/2566

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Control

No Intervention group

Description:

Nutritional advise

Intervention

Experimental group

Description:

Medical supplement and nutritional advise

Treatment:

Dietary Supplement: Ensure