Clinical trial · Interventional
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
NCT06311357CI-TRIAL-00084142unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Early Stage Breast Cancer | Early Stage Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ensure | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Control
- description
- Nutritional advise
- type
- EXPERIMENTAL
- label
- Intervention
- description
- Medical supplement and nutritional advise
- interventionNames
- Dietary Supplement: Ensure
Primary outcomes (1)
- measure
- Percent weight change
- timeFrame
- 12 weeks
- description
- The change of body weight (%) before and after chemotherapy treatment
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (6)
- RESULTMuscaritoli M, Arends J, Bachmann P, Baracos V, Barthelemy N, Bertz H, Bozzetti F, Hutterer E, Isenring E, Kaasa S, Krznaric Z, Laird B, Larsson M, Laviano A, Muhlebach S, Oldervoll L, Ravasco P, Solheim TS, Strasser F, de van der Schueren M, Preiser JC, Bischoff SC. ESPEN practical guideline: Clinical Nutrition in cancer. Clin Nutr. 2021 May;40(5):2898-2913. doi: 10.1016/j.clnu.2021.02.005. Epub 2021 Mar 15. PMID 33946039
- RESULTHebuterne X, Lemarie E, Michallet M, de Montreuil CB, Schneider SM, Goldwasser F. Prevalence of malnutrition and current use of nutrition support in patients with cancer. JPEN J Parenter Enteral Nutr. 2014 Feb;38(2):196-204. doi: 10.1177/0148607113502674. PMID 24748626
- RESULTDewys WD, Begg C, Lavin PT, Band PR, Bennett JM, Bertino JR, Cohen MH, Douglass HO Jr, Engstrom PF, Ezdinli EZ, Horton J, Johnson GJ, Moertel CG, Oken MM, Perlia C, Rosenbaum C, Silverstein MN, Skeel RT, Sponzo RW, Tormey DC. Prognostic effect of weight loss prior to chemotherapy in cancer patients. Eastern Cooperative Oncology Group. Am J Med. 1980 Oct;69(4):491-7. doi: 10.1016/s0149-2918(05)80001-3. PMID 7424938
- RESULTSukaraphat N, Chewaskulyong B, Buranapin S. Dietary Counseling Outcomes in Locally Advanced Unresectable or Metastatic Cancer Patients Undergoing Chemotherapy. J Med Assoc Thai. 2016 Dec;99(12):1283-90. PMID 29952503
- RESULTOvesen L, Allingstrup L, Hannibal J, Mortensen EL, Hansen OP. Effect of dietary counseling on food intake, body weight, response rate, survival, and quality of life in cancer patients undergoing chemotherapy: a prospective, randomized study. J Clin Oncol. 1993 Oct;11(10):2043-9. doi: 10.1200/JCO.1993.11.10.2043. PMID 8410128
- DERIVEDTienchaiananda P, Juntong M, Pintasiri P, Sa-Nguansai S, Payapwattanawong S, Maneenil K. Body weight change in a medical supplement group in patients with early breast cancer during chemotherapy: a randomized, controlled trial. Support Care Cancer. 2025 Mar 19;33(4):299. doi: 10.1007/s00520-025-09359-z.