'Palliative-D' Vitamin D to Palliative Cancer Patients (Palliative-D)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03038516|
Recruitment Status : Recruiting
First Posted : January 31, 2017
Last Update Posted : January 31, 2018
|Condition or disease||Intervention/treatment||Phase|
|Vitamin D Deficiency||Drug: Cholecalciferol Device: Placebo||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||254 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
Active Comparator: Vitamin D
Cholecalciferol (Detremin) solved in MIGLYOL® 812
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
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
- 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.
- 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.
- 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.
- Change in Fatigue after12 weeks [ Time Frame: 12 weeks ]Change in Fatigue measured with EORTC-QLQ-C15-PAL at baseline and after 12 weeks.
- 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.
- 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.
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
|Contact: Linda Björkhem-Bergman, Assoc Prof||+46 8 1234 77 email@example.com|
|Contact: Maria Helde-Frankling, MD||+46 8 1234 77 firstname.lastname@example.org|
|Stockholms Sjukhem ASIH||Recruiting|
|Stockholm, Sweden, 11219|
|Contact: Linda Björkhem-Bergman, PhD, MD +46 8 1234 77 70 email@example.com|
|Contact: Marie Nordström, PhD, MD +46 8-617 93 97 firstname.lastname@example.org|
|Principal Investigator: Marie Nordström, PhD, MD|
|ASIH Stockholm Södra||Recruiting|
|Älvsjö, Sweden, 12559|
|Contact: Linda Björkhem-bergman, Assoc prof +46 8 1234 77 70 email@example.com|
|Contact: Maria Helde-Frankling, MD +46 8 1234 77 00 firstname.lastname@example.org|
|Principal Investigator:||Linda Björkhem-Bergman, Assoc Prof||Stockholm Läns Landsting|