Vitamin D and Pre Cachexia and Cancer Cachexia in Epithelial Ovarian Cancer (VitD)

June 18, 2022 updated by: dr. Nurul Ratna Mutu Manikam, M.Gizi., Sp.GK, Indonesia University

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Indonesia
      • Jakarta, Indonesia, 13430
        • Recruiting
        • Dharmais National Cancer Hospital
        • Contact:
        • Contact:
    • DKI Jakarta
      • Jakarta, DKI Jakarta, Indonesia, 13430
        • Recruiting
        • Cipto Mangunkusumo hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Nurul Ratna Mutu Manikam, MD,MSc
        • Principal Investigator:
          • Andrijono Andrijono, MD,PhD,Prof
        • Sub-Investigator:
          • Fiastuti Witjaksono, MD,MSc,PhD
        • Sub-Investigator:
          • Fariz Nurwidya, MD,PhD
        • Sub-Investigator:
          • Sri Hartini, MD,MSc,PhD
    • Jakarta
      • Jakarta Pusat, Jakarta, Indonesia, 13430
        • Not yet recruiting
        • Tarakan Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 56 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Vitamin D group
Daily vitamin D3 2000 IU on day 1 through day 180 Intervention: vitamin D3 2000 IU
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 Names:
  • cholecalciferol
Placebo Comparator: Control group
Daily placebo (saccharum lactis) on day 1 through day 180 Intervention: placebo
Other: Placebo
Placebo capsule: Each capsule contain saccharum lactis. One capsule will be taken on day 1 through 180

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Find the change of vitamin D level
Time Frame: 6 month
vitamin D level is measured by Electro-Chemiluminescence Immunoassay (e CLIA). The normal range is 30-100 ng/ml
6 month
Find the daily intake of vitamin D from food
Time Frame: 1 month
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
Find the rate of sun exposure
Time Frame: 1 week
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
Effect of vitamin D in lowering inflammation
Time Frame: 6 months
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
Effect of vitamin D in lowering circulation tumor cells (CTC)
Time Frame: 6 months
the number of tumor cells in blood. Positive CTC if there are 5 tumor cells in 7,5 ml of blood
6 months
Effect of vitamin D in improving staging of cachexia
Time Frame: 6 month
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indonesia University

Collaborators

Dharmais National Cancer Center Hospital

Investigators

  • Principal Investigator: Nurul Ratna Mutu Manikam, MD, MSc, Indonesia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 12, 2022

Primary Completion (Anticipated)

November 30, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

April 11, 2021

First Submitted That Met QC Criteria

April 26, 2021

First Posted (Actual)

April 28, 2021

Study Record Updates

Last Update Posted (Actual)

June 22, 2022

Last Update Submitted That Met QC Criteria

June 18, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VitDCaOV

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Details will be provided at a later date

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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