MedTrace Logo

The Role of Vitamin D3 Supplementation in Advanced Cancer Patients With Pain

NCT05450419 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2023-08-31

No results posted yet for this study

Summary

Many patients with cancer have insufficient vitamin D levels, and low vitamin D levels are associated with increased 'all-cause mortality' and especially mortality due to cancer. Vitamin D has anti-cancer effects, including anti-proliferation, anti-angiogenesis, and anti-inflammation. Besides, low vitamin D levels are associated with higher opioid dose usage, fatigue, and impaired quality of life in palliative cancer patients. Therefore, patients with low vitamin D levels needs instant vitamin D supplement with "stoss therapy" which is single high dose vitamin D with maintenance dose by enteral route. The stoss therapy has been applied in many fields, including neonatal, diabetes, hemodialysis, heart failure, osteoporosis. In critically ill patients, such as surgical, medical, burn intensive unit admission patients, high dose vitamin D supplement was associated lower mortality amount the vitamin D deficiency patients. This study aims for evaluating the effects of enteral high dose vitamin D supplement on advanced cancer patients with pain, serum concentration changes of vitamin D, quality of life, symptom burden, and analyze its correlation with inflammation, immune and nutritional markers.

Conditions

Interventions

DIETARY_SUPPLEMENT

Vitamin D3

8pc (576,000 IU/40ml) vitamin D3 on week 1, then 1pc (72,000 IU/5ml) vitamin D3 on week 2, week 3 \& week 4.

DIETARY_SUPPLEMENT

placebo

8pc placebo on week 1, then 1pc placebo on week 2, week 3 \& week 4.

Sponsors & Collaborators

  • Chang Gung Memorial Hospital

    lead OTHER

Principal Investigators

  • Hang Huong Ling, MD · Chang Gung Memorial Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-01
Primary Completion
2024-12-31
Completion
2025-06-30

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05450419 on ClinicalTrials.gov