RecruitingNot ApplicableNCT06311357

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


Sponsor

Department of Medical Services Ministry of Public Health of Thailand

Enrollment

40 participants

Start Date

Jul 12, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study examines whether a specific medical nutritional supplement can help early-stage breast cancer patients maintain or manage their weight during chemotherapy with doxorubicin and cyclophosphamide. Weight changes during chemotherapy can affect outcomes and quality of life. **You may be eligible if...** - You have been diagnosed with stage I, II, or III breast cancer (confirmed by biopsy) - You are receiving doxorubicin and cyclophosphamide chemotherapy at Rajavithi Hospital - Your heart's pumping function is normal or near-normal (ejection fraction ≥ 60%) - Your general health status is good (ECOG score 0–1) **You may NOT be eligible if...** - Your cancer has spread to distant organs (stage IV) - You have diabetes that requires insulin injections - Your BMI is 30 or above, or 16 or below - You have had prior chemotherapy or radiation therapy - You are pregnant or breastfeeding - You have advanced kidney disease (CKD stage 4–5) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTEnsure

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


Locations(1)

Rajavithi hospital

Ratchathewi, Bangkok, Thailand

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NCT06311357


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