Early Stage Breast Cancer
Conditions
Keywords
Medical supplement, Weight change in early breast cancer treatment
Brief 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.
Interventions
DIETARY_SUPPLEMENTEnsure
Ensure 6 scoops dietary supplement powder in 250 ml of water, 2 drinks per days for 12 weeks.
Sponsors
Department of Medical Services Ministry of Public Health of Thailand
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent weight change | 12 weeks | The change of body weight (%) before and after chemotherapy treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| EORTC QLQ-BR23 | 12 weeks | The change of Global Quality of life before and after chemotherapy treatment score |
| EORTC QLQ-C30 | 12 weeks | The change of Global Quality of life before and after chemotherapy treatment score |
| Patient interpretation of the Patient-Generated Subjective Global Assessment | 12 weeks | PG-SGA |
Countries
Thailand
Contacts
Primary ContactMeitinarth Juntong
Outcome results
None listed