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

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.

Sex

All

Minimum age

20 Years

Maximum age

80 Years

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

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