Ignite Creation Date:
2024-05-06 @ 4:05 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04864431
Status:
UNKNOWN
Last Update Posted:
2022-06-22
First Post:
2021-04-11
Brief Title:
Vitamin D and Pre Cachexia and Cancer Cachexia in Epithelial Ovarian Cancer
Sponsor:
Indonesia University
Organization:
Indonesia University
Study Overview
Official Title:
The Effect of Vitamin D on Factors Contributing Pre Cachexia and Cachexia a Study on Epithelial Ovarian Cancer
Status:
UNKNOWN
Status Verified Date:
2022-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VitD
Brief Summary:
Several ex vivo in vitro and observational studies on various type of cancer shown positive effect of vitamin D Vitamin D has widely known as immunomodulator property in various diseases However it remains limited studies on immunity and cachexia in cancer particularly in ovarian cancer This study will investigate the effect of vitamin D in immune response during chemotherapy among epithelial ovarian cancer patients who have a low level of vitamin D and cachexia
Detailed Description:
Studies result from laboratory suggested that vitamin D inhibit cancer cell proliferation and upregulate apoptosis pathway Data from observational and ecology studies showed the inverse relationship between level of vitamin D and cancer risk Clinical trials on colorectal prostate and breast cancer suggested that vitamin D had positive effect and improved clinical markers
Vitamin D may alter immune response through regulation on cytotoxic CD8 T-lymphocyte and reduce pro inflammatory cytokines High level of interleukin-6 and other cytokines in cancer may decrease lymphocyte T activity resulting lowering effect of immune response
This clinical trial will enroll 54 adults with newly diagnosed epithelial ovarian cancer patients Following receive of informed consent they will randomly allocated to receive whether vitamin D 2000 IU or placebo during chemotherapy period 6 cycles
Subjects will fill out questionnaire on their first visit as well as each chemotherapy cycle each month Questionnaire will ask about demographic data meal intake sun exposure and cachexia questionnaire based on Cachexia Score Subjects will also be examined on their physical status anthropometry weight height waist circumference as well as body composition fat mass fat free mass fat free mass index phase angle
Blood samples will be drawn from peripheral vein and sent to National Cancer Referral Hospital laboratory to measure 25OHD level interleukin-6 CD8 cytotoxic level CD8 cytotoxic activity and circulating tumor cells Blood collection will be done on the first visit 3rd cycle of chemotherapy and last cycle of chemotherapy Subjects will be given their samples result during follow-up visit
Vitamin D3 Prove D3 is donated from PT Kalbe Farma Departement of Medicine Physic Indonesia University as the third party which provides randomization and capsules containing vitamin D and placebo Randomization key will be opened by the third party after finishing statistical data analysis This study is being submitted a grant from Kalbe-BRIN
Vitamin D may alter immune response through regulation on cytotoxic CD8 T-lymphocyte and reduce pro inflammatory cytokines High level of interleukin-6 and other cytokines in cancer may decrease lymphocyte T activity resulting lowering effect of immune response
This clinical trial will enroll 54 adults with newly diagnosed epithelial ovarian cancer patients Following receive of informed consent they will randomly allocated to receive whether vitamin D 2000 IU or placebo during chemotherapy period 6 cycles
Subjects will fill out questionnaire on their first visit as well as each chemotherapy cycle each month Questionnaire will ask about demographic data meal intake sun exposure and cachexia questionnaire based on Cachexia Score Subjects will also be examined on their physical status anthropometry weight height waist circumference as well as body composition fat mass fat free mass fat free mass index phase angle
Blood samples will be drawn from peripheral vein and sent to National Cancer Referral Hospital laboratory to measure 25OHD level interleukin-6 CD8 cytotoxic level CD8 cytotoxic activity and circulating tumor cells Blood collection will be done on the first visit 3rd cycle of chemotherapy and last cycle of chemotherapy Subjects will be given their samples result during follow-up visit
Vitamin D3 Prove D3 is donated from PT Kalbe Farma Departement of Medicine Physic Indonesia University as the third party which provides randomization and capsules containing vitamin D and placebo Randomization key will be opened by the third party after finishing statistical data analysis This study is being submitted a grant from Kalbe-BRIN
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None