UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054961 |
|---|---|
| Receipt number | R000062761 |
| Scientific Title | Effect of Egg Protein, Omega-3 fatty acid, and Vitamin D on Immuno-nutritional Status and Quality of life of Breast Cancer Patients undergoing Chemotherapy: A Randomized Control Trial |
| Date of disclosure of the study information | 2025/12/31 |
| Last modified on | 2024/07/14 16:54:33 |
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Basic information
Public title
Nutritional Supplements and Quality of Life in Breast Cancer Patients Undergoing Chemotherapy: A Randomized Control Trial
Acronym
NSQL-BCPRCT
Scientific Title
Effect of Egg Protein, Omega-3 fatty acid, and Vitamin D on Immuno-nutritional Status and Quality of life of Breast Cancer Patients undergoing Chemotherapy: A Randomized Control Trial
Scientific Title:Acronym
EPD-QoLBCPRCT
Region
| Asia(except Japan) |
Condition
Condition
Breast Cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the quality of life through supplementation of gold standard protein-egg, omega-3 fatty acids and vitamin D to breast cancer chemotherapy patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Quality of life and nutritional status
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Medicine | Food |
Interventions/Control_1
vitamin d
Interventions/Control_2
egg
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 26 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Female
Key inclusion criteria
Patients who were in stage I to IIIB of newly diagnosed (laboratory-confirmed) breast cancer, and who were undergoing intravenous chemotherapy for the first or second cycle, those who had given informed consent, and had at least one mobile number and took food enteral were eligible
Key exclusion criteria
History of recurrence, metastasis, or treatment failure were excluded
Target sample size
104
Research contact person
Name of lead principal investigator
| 1st name | Khursheda |
| Middle name | |
| Last name | Akhtar |
Organization
National Institute of Preventive and Social Medicine
Division name
Dhaka
Zip code
1212
Address
Mohakhali, Dhaka 1212
TEL
+8801714712174
dr.khursheda1974@gmail.com
Public contact
Name of contact person
| 1st name | Khursheda |
| Middle name | |
| Last name | Akhtar |
Organization
National Institute of Preventive and Social Medicine
Division name
Dhaka
Zip code
1212
Address
Mohakhali, Dhaka 1212
TEL
+8801714712174
Homepage URL
dr.khursheda1974@gmail.com
Sponsor or person
Institute
person
Institute
Department
Personal name
Funding Source
Organization
Bangladesh medical research council
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Bangladesh Medical Research Council
Address
Mohakhali
Tel
+8802-222298396
info@bmrcbd.org.
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 12 | Month | 31 | Day |
Related information
URL releasing protocol
Not applicable
Publication of results
Unpublished
Result
URL related to results and publications
Not applicable
Number of participants that the trial has enrolled
104
Results
Global Assessment (SGA) scores of the breast cancer patients (intervention vs control group) across three timelines p values between groups case versus control had significant association. .Quality of life (QOL) scores of the breast cancer patients (intervention versus Control group) across significant association.
Results date posted
| 2024 | Year | 07 | Month | 14 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients who were in stage I to IIIB of newly diagnosed (laboratory-confirmed) breast cancer, and who were undergoing intravenous chemotherapy for the first or second cycle, those who had given informed consent, and had at least one mobile number and took food enteral were eligible; patients with history of recurrence, metastasis, or treatment failure were excluded.
Participant flow
500 participants were initially include, then data collected at baseline, after 3 weeks and after 6th weeks
Adverse events
Not occurred
Outcome measures
Subjective Global Assessment (SGA) scores, quality of life, Immunoglobulin G
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2019 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 28 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 24 | Day |
Last follow-up date
| 2022 | Year | 05 | Month | 22 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 07 | Month | 14 | Day |
Last modified on
| 2024 | Year | 07 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062761
