Percent Weight Change in the Medical Supplement Group of Early Breast Cancer

NCT06311357 | Recruiting

• 1 other identifier: 100/2566
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Early Stage Breast Cancer

Keywords

Medical supplement; Weight change in early breast cancer treatment

Outcome Measures

Primary Outcomes (1)

• Percent weight change

  The change of body weight (%) before and after chemotherapy treatment

  12 weeks

Secondary Outcomes (3)

• EORTC QLQ-C30

  12 weeks

• Patient interpretation of the Patient-Generated Subjective Global Assessment

  12 weeks

• EORTC QLQ-BR23

  12 weeks

Study Arms (2)

Control

NO INTERVENTION

Nutritional advise

Intervention

EXPERIMENTAL

Medical supplement and nutritional advise

Dietary Supplement: Ensure

Interventions

Ensure DIETARY_SUPPLEMENT

Ensure 6 scoops dietary supplement powder in 250 ml of water, 2 drinks per days for 12 weeks.

Intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Department of Medical Services Ministry of Public Health of Thailand: lead

Study Sites (1)

Rajavithi hospital

Ratchathewi, Bangkok, 10400, Thailand

RECRUITING

Related Publications (6)

• 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.

  PMID: 33946039 BACKGROUND

• 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.

  PMID: 24748626 BACKGROUND

• 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.

  PMID: 7424938 BACKGROUND

• 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.

  PMID: 29952503 BACKGROUND

• 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.

  PMID: 8410128 BACKGROUND

• 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.

  PMID: 40106001 DERIVED

Study Officials

• Piyawan Tienchaiananda

  Department of Medical Services Ministry of Public Health of Thailand

  STUDY DIRECTOR

Central Study Contacts

Meitinarth Juntong

CONTACT

+66654415447; juntong.mei@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2023
• First Posted: March 15, 2024
• Study Start: July 12, 2023
• Primary Completion: April 26, 2024
• Study Completion: December 30, 2024
• Last Updated: December 27, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)