Epithelial Ovarian CancerVitDNCT04864431
Vitamin D and Pre Cachexia and Cancer Cachexia in Epithelial Ovarian Cancer
A study testing Vitamin D in people with Epithelial Ovarian Cancer, run by Universitas Indonesia at 3 sites in Indonesia.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Epithelial Ovarian Cancer
- What is being tested?
- Vitamin D
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 3 sitesIndonesia
- Study dates
- 12 Jan 2022to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- age 18-60 years old who are newly diagnosed with ovarian cancer based on histopathology
- epithelial ovarian cancer stage II-III
- haven't received chemotherapy
- pre-cachexia or cachexia
- level of vitamin D below 30 ng/ml
- no vitamin D allergy
- ability and willingness to understand and provide informed consent
Who cannot join
- autoimmune disease
- chronic liver disease
- chronic renal disease
- known had hypercalcemia
- refractory cachexia
Trial locations and contacts
3 sites in 1 country.
Indonesia3 sites, 3 recruiting
- Recruiting
Cipto Mangunkusumo Hospital
Jakarta, DKI Jakarta, 13430
Nurul Ratna Mutu Manikam, MD,MSc, 62081210106679, nurul.ratna@hotmail.com
Andrijono Andrijono, MD,PhD,Prof, 620816844824 ext. Manikam, nurul.ratna01@gmail.com
- Recruiting
Dharmais National Cancer Hospital
Jakarta, 13430
Nurul Ratna Mutu Manikam, MD,MSc, 62081210106679, nurul.ratna@hotmail.com
Sri Hartini Harijanto, MD,MSc,PhD, 6208159005011, sri.harijanto@gmail.com
- Not yet recruiting
Tarakan Hospital
Jakarta Pusat, Jakarta Special Capital Region, 13430
Nurul Ratna M Manikam, 081210106679, nurul.ratna01@gmail.com
About this study
Official title: The Effect of Vitamin D on Factors Contributing Pre Cachexia and Cachexia, a Study on Epithelial Ovarian Cancer
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
Read the 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.
- Conditions
- Epithelial Ovarian Cancer
- Being tested
- Vitamin D, Placebo
- Keywords
- Vitamin D, Pre cachexia, Cachexia, Epithelial ovarian cancer
- Medical subject headings
- Carcinoma, Ovarian Epithelial, Cachexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDietary supplement
Also called cholecalciferol
Vitamin D capsules: each capsule contain 2 tablets of vitamin D 1000 IU. One capsule will be taken on day 1 through 180
PlaceboOther
Placebo capsule: Each capsule contain saccharum lactis. One capsule will be taken on day 1 through 180
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D group | Active comparator | Daily vitamin D3 2000 IU on day 1 through day 180 Intervention: vitamin D3 2000 IU Receives: Dietary Supplement: Vitamin D |
| Control group | Placebo comparator | Daily placebo (saccharum lactis) on day 1 through day 180 Intervention: placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of immune response in participants receiving vitamin D change from baseline as assessed by lymphocyte CD8
lymphocyte CD8 is measured by flowcytometry
Measured: 6 months
Secondary outcomes (6)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2021
- Study start12 Jan 2022
- Primary completion30 Nov 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epithelial Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention group: vitamin D 2000 IU ; Control group: placebo
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Collaborators
- Dharmais National Cancer Center Hospital
- Responsible party
- Principal investigator, dr. Nurul Ratna Mutu Manikam, M.Gizi., Sp.GK, Universitas Indonesia
- Investigators
- Nurul Ratna Mutu Manikam, MD, MSc, Principal investigator, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04864431
- Sponsor's protocol ID
- VitDCaOV
- Acronym
- VitD
- Status last verified
- Jun 2022
- First submitted
- 11 Apr 2021
- Last updated
- 22 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Details will be provided at a later date
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Vitamin D on Factors Contributing Pre Cachexia and Cachexia, a Study on Epithelial Ovarian Cancer
- ClinicalTrials.gov ID
- NCT04864431
- Acronym / sponsor ID
- VitD / VitDCaOV
- Conditions
- Epithelial Ovarian Cancer
- Keywords
- Vitamin D, Pre cachexia, Cachexia, Epithelial ovarian cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Collaborators
- Dharmais National Cancer Center Hospital
- Study start
- 12 Jan 2022 (actual)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 28 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Intervention group: vitamin D 2000 IU ; Control group: placebo
| Arm | Type | Receives |
|---|---|---|
| Vitamin D group | Active comparator | Dietary Supplement: Vitamin DDaily vitamin D3 2000 IU on day 1 through day 180 Intervention: vitamin D3 2000 IU |
| Control group | Placebo comparator | Other: PlaceboDaily placebo (saccharum lactis) on day 1 through day 180 Intervention: placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- age 18-60 years old who are newly diagnosed with ovarian cancer based on histopathology
- epithelial ovarian cancer stage II-III
- haven't received chemotherapy
- pre-cachexia or cachexia
- level of vitamin D below 30 ng/ml
Key exclusion criteria (5 listed)
- autoimmune disease
- chronic liver disease
- chronic renal disease
- known had hypercalcemia
- refractory cachexia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin DAlso: cholecalciferolVitamin D capsules: each capsule contain 2 tablets of vitamin D 1000 IU. One capsule will be taken on day 1 through 180 | Dietary supplement | Vitamin D group |
| PlaceboPlacebo capsule: Each capsule contain saccharum lactis. One capsule will be taken on day 1 through 180 | Other | Control group |
Primary outcome
Rate of immune response in participants receiving vitamin D change from baseline as assessed by lymphocyte CD8
Time frame: 6 months
lymphocyte CD8 is measured by flowcytometry
6 secondary outcomes
Find the change of vitamin D level
Time frame: 6 month
Find the daily intake of vitamin D from food
Time frame: 1 month
Find the rate of sun exposure
Time frame: 1 week
Effect of vitamin D in lowering inflammation
Time frame: 6 months
Effect of vitamin D in lowering circulation tumor cells (CTC)
Time frame: 6 months
Effect of vitamin D in improving staging of cachexia
Time frame: 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2022.
- Individual participant dataSharing planned: No. Details will be provided at a later date
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nurul Ratna Mutu Manikam, MD, MSc principal investigator
Universitas Indonesia
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D in people with Epithelial Ovarian Cancer, run by Universitas Indonesia at 3 sites in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nurul Ratna Mutu Manikam, MD,MSc (62081210106679, nurul.ratna@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of immune response in participants receiving vitamin D change from baseline as assessed by lymphocyte CD8 (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2022.