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'Palliative-D' Vitamin D to Palliative Cancer Patients (Palliative-D)

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ClinicalTrials.gov Identifier: NCT03038516
Recruitment Status : Recruiting
First Posted : January 31, 2017
Last Update Posted : January 31, 2018
Sponsor:
Information provided by (Responsible Party):
Linda Björkhem-Bergman, Stockholm County Council, Sweden

Brief Summary:
To test the hypothesis that vitamin D treatment during 12 weeks to palliative cancer patients can decrease opioid consumption, fatigue and infectious burden and increase quality of life.

Condition or disease Intervention/treatment Phase
Vitamin D Deficiency Drug: Cholecalciferol Device: Placebo Phase 2

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Detailed Description:

PROTOCOL IDENTITY AND OBJECTIVES: EudraCT Number 2017-000268-14 Protocol Title: Vitamin D supplementation to palliative cancer patients - A double blind, randomised controlled trial. Acronym: "Palliative-D" Trial Objectives: To test the hypothesis that vitamin D treatment during 12 weeks to palliative cancer patients can decrease opioid consumption, fatigue and infectious burden and increase quality of life.

INVESTIGATIONAL MEDICINAL PRODUCTS (IMP): Test ProductDetremin, MA holder Renapharma; Pharmaceutical Form: Oil Route of Administration: Oral route

METHODOLOGY Trial Design: Double-blind, parallel randomised and placebo controlled trial Dose/Duration 4000 IU/day for 12 weeks

Primary Endpoint:

The decline of opioid-consumption during 12 weeks in the vitamin D group compared to the placebo group, based on 3 measurements with 4 weeks intervals.

Secondary end Points:

  1. Decline in antibiotic consumption
  2. Improvement in quality of life
  3. Improvement in fatigue
  4. Vitamin D levels in serum after 12 weeks
  5. Association between opioid dose and genetic polymorphism in genes involved in the effect and metabolism of vitamin D in the body.

Efficacy Parameters:

Opioid dose, translated to fentanyl per hour measured at baseline and at week 4,8 and 12.

Antibiotic consumption expressed as % of days with antibiotics during the last 4 weeks measured at baseline and at week 4, 8 and 12.

Quality of Life measured with EORTC-QLQ-C15-PAL at baseline and after 12 weeks. Fatigue measured with EORTC-QLQ-C15-PAL at baseline and after 12 weeks. 25-hydroxyvitamin D levels in blood at baseline and after 12 weeks. ESAS (Edmonton Symptom Assessment Scale ) measured at baseline and at week 4, 8 and 12.

Safety Parameters: S-calcium will be controlled in all subjects at baseline, at week 4, 8 and 12 and U-calcium in selected cases Power: The least clinically meaningful effect is estimated to be a 20% decline in opioid dose compared to the placebo. To obtain this result with 80% power the number of patients is estimated to be 127 in each arm i.e. 254 patients in total. This includes a drop-out of 25% per group.

Statistical Analyse plan: The primary endpoint will be analysed using linear regression, using bias corrected and accelerated bootstrap confidence intervals, while controlling for baseline measure of opioid dose (similar to ANCOVA). Adjustment for other background variables - such as vitamin D-level at baseline, gender and age - will be made in a secondary analysis to gain efficiency. The continuous secondary endpoints will be analysed using the same method as the primary endpoint .

POPULATION OF TRIAL SUBJECTS Number of Subjects: 254 (127 vitamin D and 127 placebo) Description of Trial Subjects: Palliative Cancer Patients (any cancer form) with a life expectancy of more than 3 months.

TRIAL TIMETABLE First Subject In Aug 2017 Last Subject In Sept 2019 (25 months to include participants) Last Subject Out Dec 2019 End of intervention Dec 2019 End of follow up Dec2019 End of Trial: Dec 2020


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 254 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 'Palliative-D' Vitamin D Supplementation to Palliative Cancer Patients - A Double Blind, Randomised Controlled Trial
Actual Study Start Date : November 1, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

Arm Intervention/treatment
Active Comparator: Vitamin D
Cholecalciferol (Detremin) solved in MIGLYOL® 812
Drug: Cholecalciferol
To test the hypothesis that vitamin D treatment during 12 weeks to palliative cancer patients is superior to placebo in decreasing opioid consumption, fatigue and infectious burden and increase quality of life.
Other Name: Detremin

Placebo Comparator: Placebo
MIGLYOL® 812
Device: Placebo
To test the hypothesis that placebo is inferior to vitamin D treatment during 12 weeks to palliative cancer patients in decreasing opioid consumption,
Other Name: MIGLYOL® 812




Primary Outcome Measures :
  1. Change in opioid dose during 12 weeks [ Time Frame: 12 weeks ]
    The change in decline of opioid-consumption during 12 weeks in the vitamin D group compared to the placebo group, based on 4 measurements with 4 weeks intervals.


Secondary Outcome Measures :
  1. Change in Antibiotic Consumption during 12 weeks [ Time Frame: 12weeks ]
    Change in Antibiotic consumption expressed as % of days with antibiotics during the last 4 weeks measured at baseline and at week 4, 8 and 12.

  2. Change in Quality of life after 12 weeks [ Time Frame: 12 weeks ]
    Change in Quality of Life measured with EORTC-QLQ-C15-PAL at baseline and after 12 weeks.

  3. Change in Fatigue after12 weeks [ Time Frame: 12 weeks ]
    Change in Fatigue measured with EORTC-QLQ-C15-PAL at baseline and after 12 weeks.

  4. Change in 25-hydroxyvitamin D levels after 12 weeks [ Time Frame: 12 weeks ]
    Change in 25-hydroxyvitamin D levels in blood at baseline and after 12 weeks.

  5. Change in Symptom burden during 12 weeks [ Time Frame: 12 weeks ]
    Change in Symptom burden measured with ESAS (Edmonton Symptom Assessment Scale) at baseline and at week 4, 8 and 12.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients admitted to ASIH Stockholm Södra or Stockholms Sjukhem.
  2. Incurable cancer patients with any type of cancer. They could have ongoing oncological treatment but only with palliative intention. No patients with ongoing oncological treatment with curative intended treated will be included.
  3. The life expectancy should be at least 3 months according to the clinical assessment of the study physician at the screening visit.
  4. The patient should have no cognitive failure, being able to comprehend oral and written information about the study.
  5. 25 OHD < 50 nmol/L.
  6. Men and women aged ≥18
  7. Signed 'informed consent'

Exclusion Criteria:

  1. Ongoing vitamin D supplementation at the time for inclusion.
  2. Serum level of 25-OH vitamin D3 <50 nmol/L
  3. Known sarkoidosis
  4. Treatment with tiazides or digoxin or digitoxin
  5. Primary hyperparathyroidism
  6. Hypercalcaemia (verified by a laboratory result younger than 2 month)
  7. Plans to leave the Stockholm county within 12 weeks of inclusion
  8. History of kidney stones
  9. Taking part of another clinical study involving drugs
  10. Hypersensitivity to cholecalciferol and/or any of the excipients
  11. Other criteria that could jeopardize the study or its intention as judged by the investigator
  12. Not being able to perform EORTC-QLQ-C15-PAL or ESAS

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): NCT03038516


Contacts
Contact: Linda Björkhem-Bergman, Assoc Prof +46 8 1234 77 70 linda.bjorkhem-bergman@ki.se
Contact: Maria Helde-Frankling, MD +46 8 1234 77 00 maria-helde-franlking@ki.se

Locations
Sweden
Stockholms Sjukhem ASIH Recruiting
Stockholm, Sweden, 11219
Contact: Linda Björkhem-Bergman, PhD, MD    +46 8 1234 77 70    linda.bjorkhem-bergman@ki.se   
Contact: Marie Nordström, PhD, MD    +46 8-617 93 97    marie.nordstrom@stockholmssjukhem.se   
Principal Investigator: Marie Nordström, PhD, MD         
ASIH Stockholm Södra Recruiting
Älvsjö, Sweden, 12559
Contact: Linda Björkhem-bergman, Assoc prof    +46 8 1234 77 70    linda.bjorkhem-bergman@ki.se   
Contact: Maria Helde-Frankling, MD    +46 8 1234 77 00    maria.helde.frankling@ki.se   
Sponsors and Collaborators
Stockholm County Council, Sweden
Investigators
Principal Investigator: Linda Björkhem-Bergman, Assoc Prof Stockholm Läns Landsting

Responsible Party: Linda Björkhem-Bergman, MD, PhD, Assoc Prof, Senior Consultant, Stockholm County Council, Sweden
ClinicalTrials.gov Identifier: NCT03038516     History of Changes
Other Study ID Numbers: Palliative-D
First Posted: January 31, 2017    Key Record Dates
Last Update Posted: January 31, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents