Vitamin D to improve Fatigue and Quality of Life in Patients with Colorectal Cancer

Personalized Vitamin D Supplementation for Reducing or Preventing Fatigue and Enhancing Quality of Life of Patients with Colorectal Tumor: Randomized Intervention Trial - Vitamin D for Reducing Cancer related Fatigue and Enhancing Quality of Life

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-000502-30-DE

Enrollment

456

Registered

2020-02-06

Start date

2020-03-26

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fatigue in patients with colorectal cancer (ICD codes C18-C20 and C21.8) within 12 months after a colorectal cancer therapy (surgery, chemotherapy and/ or radiation) and not optimal vitamin D status MedDRA version: 22.0 Level: PT Classification code 10082239 Term: Cancer fatigue System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.0 Level: PT Classification code 10061451 Term: Colorectal cancer System Organ Class: 10029104 - Neo

Interventions

Trade Name: Dekristol® 20 000 I.E. Weichkapseln Pharmaceutical Form: Capsule, hard INN or Proposed INN: COLECALCIFEROL CAS Number: 67-97-0 Other descriptive name: Vitamin D3 Concentration unit: IU int

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Age = 18 years - Colorectal cancer patients - Both men and women - Colorectal cancer therapy in last 12 months (surgical removal of tumor, radiation and/ or chemotherapy (adjuvant or neoadjuvant)) - At least 3 weeks in-patient rehabilitation in a cooperating clinic is planned - Sufficient knowledge of the German language and mental capabilities to be able to give written informed consent and comply with the study requirements Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 156 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 300

Exclusion criteria

Exclusion criteria: - Sufficient vitamin D status (25(OH)D > 60 nmol/L) - Severe renal impairment (eGFR 1000 mg calcium daily) - Participation in another intervention trial - Pregnancy, planned pregnancy in next 12 weeks, or lactation - No use of adequate contraceptive measures in women of childbearing potential

Design outcomes

Primary

Measure	Time frame
Main Objective: To test whether the proposed personalized vitamin D3 dosing regimen reduces or prevents fatigue (primary outcome) among colorectal cancer patients with no optimal vitamin D status. ;Secondary Objective: To investigate the impact of a personalized vitamin D3 supplementation on the vitamin D status, the change of the fatigue score between baseline and follow-up, the fatigue domains (physical, emotional, and cognitive fatigue), quality of life, functional well-being, probable depression, infection frequency and other blood biomarkers (secondary endpoints). ;Primary end point(s): Mean difference in FACIT-F fatigue subscale between intervention and placebo group. A mean difference = 3 FACIT-F fatigue subscale points will be considered a clinically relevant difference.;Timepoint(s) of evaluation of this end point: Week 13 to 16	—

Measure

Time frame

Main Objective: To test whether the proposed personalized vitamin D3 dosing regimen reduces or prevents fatigue (primary outcome) among colorectal cancer patients with no optimal vitamin D status. ;Secondary Objective: To investigate the impact of a personalized vitamin D3 supplementation on the vitamin D status, the change of the fatigue score between baseline and follow-up, the fatigue domains (physical, emotional, and cognitive fatigue), quality of life, functional well-being, probable depression, infection frequency and other blood biomarkers (secondary endpoints). ;Primary end point(s): Mean difference in FACIT-F fatigue subscale between intervention and placebo group. A mean difference = 3 FACIT-F fatigue subscale points will be considered a clinically relevant difference.;Timepoint(s) of evaluation of this end point: Week 13 to 16

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Secondary

Measure	Time frame
Secondary end point(s): - Mean difference in change of FACIT-F fatigue subscale from baseline to trial week 13-16 between intervention and placebo group. A mean difference = 3 FACIT-F fatigue subscale points will be considered a clinically relevant difference - Mean differences in EORTC-FA12 physical, emotional and cognitive fatigue scores between intervention and placebo group as well as mean differences in changes in these scores from baseline to trial week 13-16 between intervention and placebo group. - Mean difference in GDS-15 scale between intervention and placebo group as well as mean difference in changes in this scale from baseline to trial week 13-16 between intervention and placebo group. - Mean difference in FACIT-F functional well-being (FWB) score between intervention and placebo group as well as mean difference in changes in this score from baseline to trial week 13-16 between intervention and placebo group. - Mean differences in overall and domain specific quality of life scores of the EORTC QLQ-C30 questionnaire between intervention and placebo group as well as mean differences in changes in these scores from baseline to trial week 13-16 between intervention and placebo group. Mean differences = 5 points in the overall and domain specific scores of the EORTC QLQ-C30 will be considered clinically relevant differences. - Mean differences in infection frequencies (total, upper respiratory and lower respiratory tract infections) between intervention and placebo group. - Mean difference in levels of total serum 25(OH)D between intervention and placebo group as well as mean difference in change of levels of total serum 25(OH)D from baseline to trial day 12-21 and from baseline to trial week 13-16. - Mean serum 25(OH)D levels > 60 nmol/L in intervention group. - Mean differences in levels of disease biomarkers (including white blood cell count (WBC), leukocyte subtype counts (neutrophils, eosinophils, basophils, lymphocytes, and monocytes), platele	—

Measure

Time frame

Secondary end point(s): - Mean difference in change of FACIT-F fatigue subscale from baseline to trial week 13-16 between intervention and placebo group. A mean difference = 3 FACIT-F fatigue subscale points will be considered a clinically relevant difference - Mean differences in EORTC-FA12 physical, emotional and cognitive fatigue scores between intervention and placebo group as well as mean differences in changes in these scores from baseline to trial week 13-16 between intervention and placebo group. - Mean difference in GDS-15 scale between intervention and placebo group as well as mean difference in changes in this scale from baseline to trial week 13-16 between intervention and placebo group. - Mean difference in FACIT-F functional well-being (FWB) score between intervention and placebo group as well as mean difference in changes in this score from baseline to trial week 13-16 between intervention and placebo group. - Mean differences in overall and domain specific quality of life scores of the EORTC QLQ-C30 questionnaire between intervention and placebo group as well as mean differences in changes in these scores from baseline to trial week 13-16 between intervention and placebo group. Mean differences = 5 points in the overall and domain specific scores of the EORTC QLQ-C30 will be considered clinically relevant differences. - Mean differences in infection frequencies (total, upper respiratory and lower respiratory tract infections) between intervention and placebo group. - Mean difference in levels of total serum 25(OH)D between intervention and placebo group as well as mean difference in change of levels of total serum 25(OH)D from baseline to trial day 12-21 and from baseline to trial week 13-16. - Mean serum 25(OH)D levels > 60 nmol/L in intervention group. - Mean differences in levels of disease biomarkers (including white blood cell count (WBC), leukocyte subtype counts (neutrophils, eosinophils, basophils, lymphocytes, and monocytes), platele

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Countries

Germany

Contacts

Public ContactClinical Trial Office

German Cancer Research Center (DKFZ)

cto@dkfz-heidelberg.de

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026