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

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ClinicalTrials.gov Identifier: NCT04864431
Recruitment Status : Not yet recruiting
First Posted : April 28, 2021
Last Update Posted : April 28, 2021
Sponsor:
Collaborator:
Dharmais National Cancer Center Hospital
Information provided by (Responsible Party):
dr. Nurul Ratna Mutu Manikam, M.Gizi., Sp.GK, Indonesia University

Study Description
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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

Condition or disease Intervention/treatment Phase
Epithelial Ovarian Cancer Dietary Supplement: Vitamin D Other: Placebo Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Intervention group: vitamin D 2000 IU ; Control group: placebo
Masking: Double (Participant, Investigator)
Masking Description: Neither do investigator nor participants will not know the random allocation
Primary Purpose: Treatment
Official Title: The Effect of Vitamin D on Factors Contributing Pre Cachexia and Cachexia, a Study on Epithelial Ovarian Cancer
Estimated Study Start Date : April 26, 2021
Estimated Primary Completion Date : April 26, 2022
Estimated Study Completion Date : October 31, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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. 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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04864431


Contacts
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Contact: Nurul Ratna Mutu Manikam, MD,MSc 62081210106679 nurul.ratna@hotmail.com
Contact: Andrijono Andrijono, Prof,MD,PhD 620816844824 andrijono@gmail.com

Locations
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Indonesia
Cipto Mangunkusumo Hospital
Jakarta, DKI Jakarta, Indonesia, 13430
Contact: Nurul Ratna Mutu Manikam, MD,MSc    62081210106679    nurul.ratna@hotmail.com   
Contact: Andrijono Andrijono, MD,PhD,Prof    620816844824 ext Manikam    nurul.ratna01@gmail.com   
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         
Dharmais National Cancer Hospital
Jakarta, Indonesia, 13430
Contact: Nurul Ratna Mutu Manikam, MD,MSc    62081210106679    nurul.ratna@hotmail.com   
Contact: Sri Hartini Harijanto, MD,MSc,PhD    6208159005011    sri.harijanto@gmail.com   
Sponsors and Collaborators
Indonesia University
Dharmais National Cancer Center Hospital
Investigators
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Principal Investigator: Nurul Ratna Mutu Manikam, MD, MSc Indonesia University
More Information
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Responsible Party: dr. Nurul Ratna Mutu Manikam, M.Gizi., Sp.GK, Principle Investigator, Indonesia University
ClinicalTrials.gov Identifier: NCT04864431    
Other Study ID Numbers: VitDCaOV
First Posted: April 28, 2021    Key Record Dates
Last Update Posted: April 28, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Details will be provided at a later date

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by dr. Nurul Ratna Mutu Manikam, M.Gizi., Sp.GK, Indonesia University:
Vitamin D
Pre cachexia
Cachexia
Epithelial ovarian cancer
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Wasting Syndrome
Cachexia
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
 Neoplasms by Histologic Type
Emaciation
Weight Loss
Body Weight Changes
Body Weight
Metabolic Diseases
Nutrition Disorders
Vitamin D
Cholecalciferol
Vitamins
Micronutrients
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents