Percent Weight Change in the Medical Supplement Group of... | NCT06311357

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

NCT06311357

Sponsor

Department of Medical Services Ministry of Public Health of Thailand

Status

Unknown status

Last Update Posted

Dec 27, 2024Actual

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Early Stage Breast Cancer

Interventions

Ensure

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 12, 2023Actual

Primary Completion Date

Apr 26, 2024Actual

Completion Date

Dec 30, 2024Estimated

First Submitted Date

Dec 12, 2023

First Submission Date that Met QC Criteria

Mar 13, 2024

First Posted Date

Mar 15, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 20, 2024

Last Update Posted Date

Dec 27, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control	No Intervention	Nutritional advise
Intervention	Experimental	Medical supplement and nutritional advise	Dietary Supplement: Ensure

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ensure	Dietary Supplement	Ensure 6 scoops dietary supplement powder in 250 ml of water, 2 drinks per days for 12 weeks.	Intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percent weight change	The change of body weight (%) before and after chemotherapy treatment	12 weeks

Secondary Outcomes

Measure	Description	Time Frame
EORTC QLQ-C30	The change of Global Quality of life before and after chemotherapy treatment score	12 weeks
Patient interpretation of the Patient-Generated Subjective Global Assessment	PG-SGA

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Meitinarth Juntong	Contact	+66654415447		juntong.mei@gmail.com

Overall Officials

Name	Affiliation	Role
Piyawan Tienchaiananda	Department of Medical Services Ministry of Public Health of Thailand	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rajavithi hospital	Recruiting	Ratchathewi	Bangkok	10400	Thailand

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33946039	Result	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.
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