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

Inclusion Criteria4

  • 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 Criteria11

  • 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

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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