Clinical trial NCT04864431: Vitamin D and Pre Cachexia and Cancer Cachexia in Epithelial Ovarian Cancer
Official title: The Effect of Vitamin D on Factors Contributing Pre Cachexia and Cachexia, a Study on Epithelial Ovarian Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Epithelial Ovarian Cancer
Keywords: Vitamin D
Pre cachexia
Cachexia
Epithelial ovarian cancer
Lead sponsor: Indonesia University
Sponsor class: OTHER
Collaborators: name: Dharmais National Cancer Center Hospital
First posted: 2021-04-28
Enrollment: 54
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention group: vitamin D 2000 IU ; Control group: placebo
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of immune response in participants receiving vitamin D change from baseline as assessed by lymphocyte CD8
timeFrame: 6 months
Secondary outcomes:
measure: Find the change of vitamin D level
timeFrame: 6 month
measure: Find the daily intake of vitamin D from food
timeFrame: 1 month
measure: Find the rate of sun exposure
timeFrame: 1 week
measure: Effect of vitamin D in lowering inflammation
timeFrame: 6 months
measure: Effect of vitamin D in lowering circulation tumor cells (CTC)
timeFrame: 6 months
measure: Effect of vitamin D in improving staging of cachexia
timeFrame: 6 month
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Cipto Mangunkusumo Hospital
state: DKI Jakarta
city: Jakarta Pusat
country: Indonesia
facility: Tarakan Hospital
state: Jakarta
city: Jakarta
country: Indonesia
facility: Dharmais National Cancer Hospital
Study officials:
affiliation: Indonesia University
name: Nurul Ratna Mutu Manikam, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: