An interventional study of Vitamin D and Placebo in Epithelial Ovarian Cancer, sponsored by Indonesia University. Status unknown at 3 sites in Indonesia. Open to female participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2022-06-22.
Sponsored by Indonesia University · Not applicable, Interventional, and Treatment
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
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 25(OH)D 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.
2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.
This study's planned enrollment of 54 is close to the median of 60 across 2,030 interventional studies indexed under Ovarian Neoplasms.
Browse Ovarian Neoplasms studies →Indonesia University is the lead sponsor of 448 studies on the registry; 56 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
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Exclusion Criteria:
Daily vitamin D3 2000 IU on day 1 through day 180 Intervention: vitamin D3 2000 IU
Dietary Supplement: Vitamin D
Daily placebo (saccharum lactis) on day 1 through day 180 Intervention: placebo
Other: Placebo
Vitamin D capsules: each capsule contain 2 tablets of vitamin D 1000 IU. One capsule will be taken on day 1 through 180
Also known as: cholecalciferol
Placebo capsule: Each capsule contain saccharum lactis. One capsule will be taken on day 1 through 180
Rate of immune response in participants receiving vitamin D change from baseline as assessed by lymphocyte CD8
lymphocyte CD8 is measured by flowcytometry
Time frame: 6 months
Find the change of vitamin D level
vitamin D level is measured by Electro-Chemiluminescence Immunoassay (e CLIA). The normal range is 30-100 ng/ml
Time frame: 6 month
Find the daily intake of vitamin D from food
The amount of vitamin D intake from food in one month is analyzed using food frequency questionnaire in microgram unit measurement. To find the daily intake from food is calculated the total intake in 1 month divided by 30 days. Recommended daily allowance of vitamin D intake from food is 15 microgram/day
Time frame: 1 month
Find the rate of sun exposure
sun exposure defined as total duration of sun exposure per day. It assessed using "sun exposure questionnaire". It is calculated based on time outdoor multiply by amount of skin exposure (face, hand, arm, leg, sun bathing), added up everyday for one week. The minimum score is 0 and the maximum score is 56. No score is defined as either adequate or inadequate exposure
Time frame: 1 week
Effect of vitamin D in lowering inflammation
defined inflammation as interleukin-6 which is measured by enzyme-linked immunosorbent assay in ng/ml unit measurement. Interleukin-6 increases if the level more than 4 pg/ml
Time frame: 6 months
Effect of vitamin D in lowering circulation tumor cells (CTC)
the number of tumor cells in blood. Positive CTC if there are 5 tumor cells in 7,5 ml of blood
Time frame: 6 months
Effect of vitamin D in improving staging of cachexia
a diagnostic tools for staging cachexia is measured by Cachexia Score (CASCO). The components of CASCO are body weight loss and composition, inflammation/metabolic disturbances, physical performance, anorexia, and quality of life. CASCO score is presented by numerical scale and classified as mild (score 0-25), moderate (26-50), severe (51-75), and terminal (76-100)
Time frame: 6 month
Plan to share: No — Details will be provided at a later date
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