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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

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