Percent Weight Change in the Medical Supplement Group of Early Breast Cancer
December 20, 2024 updated by: Rajavithi Hospital
Effects of Body Weight Change in the Medical Supplement Group in Patients with Early Breast Cancer During Chemotherapy: a Randomized, Controlled Trial
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
- 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.
- 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.
- Sample size formula based on Bernard R. Fundamentals of biostatistics. 5th ed. Duxbery: Thomson learning; 2000. Enrollment of 40 patients.
- 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
- 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.
- Data assessment on week 0,6,12 during chemotherapy treatment.
- Data analyzed by descriptive statistics to characterize patients at entry. We did the efficacy analyses with intention to treat population
- We did analyses with R version 3.3.0.
Study Type
Interventional
Enrollment (Estimated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Meitinarth Juntong
- Phone Number: +66654415447
- Email: juntong.mei@gmail.com
Study Locations
-
-
Bangkok
-
Ratchathewi, Bangkok, Thailand, 10400
- Recruiting
- Rajavithi Hospital
-
Contact:
- Meitinarth Juntong
- Phone Number: +66654415447
- Email: juntong.mei@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
Nutritional advise
|
|
|
Experimental: Intervention
Medical supplement and nutritional advise
|
Ensure 6 scoops dietary supplement powder in 250 ml of water, 2 drinks per days for 12 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percent weight change
Time Frame: 12 weeks
|
The change of body weight (%) before and after chemotherapy treatment
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
EORTC QLQ-C30
Time Frame: 12 weeks
|
The change of Global Quality of life before and after chemotherapy treatment score
|
12 weeks
|
|
Patient interpretation of the Patient-Generated Subjective Global Assessment
Time Frame: 12 weeks
|
PG-SGA
|
12 weeks
|
|
EORTC QLQ-BR23
Time Frame: 12 weeks
|
The change of Global Quality of life before and after chemotherapy treatment score
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Piyawan Tienchaiananda, Rajavithi Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 12, 2023
Primary Completion (Actual)
April 26, 2024
Study Completion (Estimated)
December 30, 2024
Study Registration Dates
First Submitted
December 12, 2023
First Submitted That Met QC Criteria
March 13, 2024
First Posted (Actual)
March 15, 2024
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
December 20, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 100/2566
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Due to this study is performed on single institution.
The study protocol will be provided later on published article.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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