Impact of a medical supplement on weight change in early breast cancer patients during chemotherapy
Effects of Body Weight Change in the Medical Supplement Group in Patients with Early Breast Cancer During Chemotherapy: a Randomized, Controlled Trial
This study is testing if a medical supplement can help early breast cancer patients maintain their weight during chemotherapy compared to just getting nutritional advice.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | Female |
| Sponsor | Department of Medical Services Ministry of Public Health of Thailand Government |
| Drugs / interventions | chemotherapy, cyclophosphamide, doxorubicin |
| Locations | 1 site (Ratchathewi, Bangkok) |
| Trial ID | NCT06311357 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effect of a medical supplement on weight change in patients with early-stage breast cancer undergoing chemotherapy. Participants will be randomly assigned to either an intervention group receiving the supplement daily or a control group receiving only nutritional advice. The primary endpoint is the percentage change in weight before and after treatment, while secondary endpoints include nutritional status and quality of life assessments. The study will enroll 40 patients at Rajavithi Hospital and monitor data at specified intervals during the treatment period.
Who should consider this trial
Good fit: Ideal candidates are patients with histopathologically confirmed early-stage breast cancer (stage I-III) who are receiving chemotherapy.
Not a fit: Patients with advanced breast cancer (stage IV), severe malnutrition requiring TPN, or those with contraindications for chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help prevent weight loss and malnutrition in breast cancer patients undergoing chemotherapy, thereby improving their quality of life.
How similar studies have performed: While similar studies have explored nutritional interventions in cancer treatment, this specific approach using a medical supplement is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Ratchathewi, Bangkok
- Rajavithi hospital — Ratchathewi, Bangkok, Thailand (Recruiting)
Study contacts
- Study coordinator: Meitinarth Juntong
- Email: juntong.mei@gmail.com
- Phone: +66654415447
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.