Clinical trial NCT06311357: Percent Weight Change in the Medical Supplement Group of Early Breast Cancer
Official title: Effects of Body Weight Change in the Medical Supplement Group in Patients with Early Breast Cancer During Chemotherapy: a Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Early Stage Breast Cancer
Keywords: Medical supplement
Weight change in early breast cancer treatment
Lead sponsor: Department of Medical Services Ministry of Public Health of Thailand
Sponsor class: OTHER_GOV
First posted: 2024-03-15
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: 1. 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.
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.

Eligibility 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

Primary outcomes:
measure: Percent weight change
timeFrame: 12 weeks
Secondary outcomes:
measure: EORTC QLQ-C30
timeFrame: 12 weeks
measure: Patient interpretation of the Patient-Generated Subjective Global Assessment
timeFrame: 12 weeks
measure: EORTC QLQ-BR23
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Ratchathewi
country: Thailand
facility: Rajavithi hospital
state: Bangkok
Study officials:
affiliation: Department of Medical Services Ministry of Public Health of Thailand
name: Piyawan Tienchaiananda
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.