Percent Weight Change in the Medical Supplement Group of Early Breast Cancer
NCT ID: NCT06311357
Last Updated: 2024-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2023-07-12
2024-12-30
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Control
Nutritional advise
No interventions assigned to this group
Intervention
Medical supplement and nutritional advise
Ensure
Ensure 6 scoops dietary supplement powder in 250 ml of water, 2 drinks per days for 12 weeks.
Interventions
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Ensure
Ensure 6 scoops dietary supplement powder in 250 ml of water, 2 drinks per days for 12 weeks.
Eligibility Criteria
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Inclusion Criteria
* Breast cancer stage I-III
* Recieve adjuvant or neoadjuvant doxorubicin and cyclophosphamide at Rajavithi hospital
* LVEF \>= 60% - ECOG score 0-1
Exclusion Criteria
* 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
18 Years
80 Years
FEMALE
Yes
Sponsors
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Department of Medical Services Ministry of Public Health of Thailand
OTHER_GOV
Responsible Party
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Principal Investigators
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Piyawan Tienchaiananda
Role: STUDY_DIRECTOR
Department of Medical Services Ministry of Public Health of Thailand
Locations
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Rajavithi hospital
Ratchathewi, Bangkok, Thailand
Countries
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Central Contacts
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Facility Contacts
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Meitinarth Juntong
Role: primary
References
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Muscaritoli 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.
Hebuterne 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.
Dewys 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.
Sukaraphat 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.
Ovesen 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.
Tienchaiananda 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.
Other Identifiers
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100/2566
Identifier Type: -
Identifier Source: org_study_id