Vitamin D and Pre Cachexia and Cancer Cachexia in Epithelial Ovarian Cancer

Epithelial Ovarian Cancer Clinical Trial

— VitD  

Official title:

The Effect of Vitamin D on Factors Contributing Pre Cachexia and Cachexia, a Study on Epithelial Ovarian Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04864431
• Other study ID #: VitDCaOV
• Status: Recruiting
• Phase: N/A
• Start date: January 12, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: June 2022
• Source: Indonesia University
• Contact: Nurul Ratna Mutu Manikam, MD,MSc
• Phone: 62081210106679
• Email: nurul.ratna[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: December 31, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

1. age 18-60 years old who are newly diagnosed with ovarian cancer based on histopathology

2. epithelial ovarian cancer stage II-III

3. haven't received chemotherapy

4. pre-cachexia or cachexia

5. level of vitamin D below 30 ng/ml

6. no vitamin D allergy

7. ability and willingness to understand and provide informed consent

Exclusion Criteria:

1. autoimmune disease

2. chronic liver disease

3. chronic renal disease

4. known had hypercalcemia

5. refractory cachexia

Related Conditions & MeSH terms

• Cachexia
• Carcinoma, Ovarian Epithelial
• Epithelial Ovarian Cancer
• Ovarian Neoplasms

Intervention

Dietary Supplement:
• Vitamin D
Vitamin D capsules: each capsule contain 2 tablets of vitamin D 1000 IU. One capsule will be taken on day 1 through 180

Other:
• Placebo
Placebo capsule: Each capsule contain saccharum lactis. One capsule will be taken on day 1 through 180

Locations

Country	Name	City	State
Indonesia	Cipto Mangunkusumo Hospital	Jakarta	DKI Jakarta
Indonesia	Dharmais National Cancer Hospital	Jakarta
Indonesia	Tarakan Hospital	Jakarta Pusat	Jakarta

Sponsors (2)

Lead Sponsor	Collaborator
Indonesia University	Dharmais National Cancer Center Hospital

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of immune response in participants receiving vitamin D change from baseline as assessed by lymphocyte CD8	lymphocyte CD8 is measured by flowcytometry	6 months
Secondary	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	6 month
Secondary	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	1 month
Secondary	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	1 week
Secondary	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	6 months
Secondary	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	6 months
Secondary	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)	6 month