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

Early Stage Breast Cancer Clinical Trial

Official title:

Effects of Body Weight Change in the Medical Supplement Group in Patients With Early Breast Cancer During Chemotherapy: a Randomized, Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06311357
• Other study ID #: 100/2566
• Status: Recruiting
• Phase: N/A
• Start date: July 12, 2023
• Est. completion date: April 30, 2024

Study information

• Verified date: March 2024
• Source: Rajavithi Hospital
• Contact: Meitinarth Juntong
• Phone: +66654415447
• Email: juntong.mei[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: April 30, 2024
• Est. primary completion date: April 26, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Weight Changes
• Breast Neoplasms
• Early Stage Breast Cancer

Intervention

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

Locations

Country	Name	City	State
Thailand	Rajavithi hospital	Ratchathewi	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Rajavithi Hospital

Country where clinical trial is conducted

Thailand, 

References & Publications (5)

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 l — View 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. — View 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, — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent weight change	The change of body weight (%) before and after chemotherapy treatment	12 weeks
Secondary	EORTC QLQ-C30	The change of Global Quality of life before and after chemotherapy treatment score	12 weeks
Secondary	Patient interpretation of the Patient-Generated Subjective Global Assessment	PG-SGA	12 weeks
Secondary	EORTC QLQ-BR23	The change of Global Quality of life before and after chemotherapy treatment score	12 weeks