Vitamin D3 supplementation for advanced cancer patients with pain
The Role of Vitamin D3 Supplementation in Advanced Cancer Patients With Pain
This study is testing if high-dose vitamin D3 can help advanced cancer patients with pain feel better and improve their quality of life while they are receiving chemotherapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 20 Years to 80 Years |
| Sex | All |
| Sponsor | Chang Gung Memorial Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Keelung) |
| Trial ID | NCT05450419 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effects of high-dose vitamin D3 supplementation on advanced cancer patients experiencing pain. It focuses on patients with recurrent or metastatic cancer who are undergoing systemic chemotherapy without curative intent. The intervention involves administering a single high dose of vitamin D followed by maintenance doses via enteral route, aiming to improve pain management and overall quality of life. The study will assess the impact of vitamin D on pain levels, opioid usage, and patient well-being.
Who should consider this trial
Good fit: Ideal candidates are adults aged 20-80 with recurrent or metastatic cancer, experiencing significant pain and requiring opioid treatment.
Not a fit: Patients with gastrointestinal issues that prevent enteral feeding or those with pre-existing hypercalcemia may not benefit from this study.
Why it matters
Potential benefit: If successful, this could lead to improved pain management and quality of life for advanced cancer patients.
How similar studies have performed: Previous studies have shown positive outcomes with vitamin D supplementation in cancer patients, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Recurrent/metastatic cancer patients scheduled to receive 2nd or later lines of systemic chemotherapy with no curative intent. * Oral equivalent morphine of at least 60 mg/day. * Visual analog scale (VAS) of pain ≥ 3. * Age between 20-80 years old. * Life expectancy should be at least 3 months according to the clinical assessment of physician. * The patient should have no cognitive dysfunction and able to answer questionnaire. Exclusion Criteria: * Abnormal gastrointestinal function: patients could not tolerate enteral feeding. * Current use of supplemental vitamin D or supplements containing vitamin D beyond the protocol. * Pre-existing hypercalcemia (defined as baseline serum calcium above the institutional upper limit of normal (ULN), corrected for albumin level if albumin is not within institutional limits of normal. * Concomitant drugs which may interfere with study evaluation: 1. Steroids: treated with steroid for medical purpose such as autoimmune disease (i.e, SLE) for long term; Short term use of corticosteroids as anti-emetic therapy for chemotherapy is permitted. 2. Astragalus Polysaccharides (PG2). 3. Chemo young oral solution. * Heart failure New York Heart Association (NYHA) Class IV. * Impaired liver function (serum total bilirubin \> 3x ULN, alanine amino transferase (ALT) or aspartate amino transferase (AST) \> 5 x ULN). * Impaired renal function: serum creatinine \> 2 x ULN. * Inadequate bone marrow function (absolute neutrophil count \< 1,500/mm\^3 (\< 1.5 x 10\^9/L), platelets \< 75,000 / mm\^3 (\< 75 x 10\^9/L) and hemoglobin \< 10 g/dL). * Uncontrolled infection * History of primary hyperparathyroidism * History of nephrolithiasis * Thiazides or digoxin use
Where this trial is running
Keelung
- Chang Gung Memorial Hospital — Keelung, Taiwan (Recruiting)
Study contacts
- Principal investigator: Hang Huong Ling, MD — Chang Gung Memorial Hospital
- Study coordinator: Li-Ting Lian
- Email: liting@cgmh.org.tw
- Phone: +886-224329292
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.