Vitamin D for Muscle Metabolic Function in Cancer Cachexia

Inclusion Criteria:

Patients must have histologically or cytologically confirmed stage II-IV lung cancer and be planned for definitive non-surgical therapy.

Patients may have a history of prior malignancy.

Mild cancer cachexia, defined by the miniCASCO score of 0-25 points

Vitamin D insufficiency, defined as 25(OH)D < 32 ng/ml

Aged 45 to 75 years. Stratified randomization by age

ECOG performance status ≤ 2 (see Appendix A).

Life expectancy of greater than 3 months

Patients must have normal renal and liver function as defined below:

AST(SGOT)/ALT(SGPT) ≤2.5 × institutional upper limit of normal creatinine within normal institutional limits OR creatinine clearance ≥60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal.

Able to swallow thin liquids

No uncontrolled illness including, but not limited to, any of the following:

• Ongoing or active serious infection
• Symptomatic congestive heart failure
• Unstable angina pectoris
• Uncontrolled cardiac arrhythmia
• Uncontrolled hypertension
• Psychiatric illness or social situation that would preclude compliance with study requirements

Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.

Patients with untreated brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. Patients with treated brain metastasis are eligible for this trial, providing they have completed treatment at least one day prior to registration.

History of allergic reactions to whey or milk proteins.

Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Patients with a history of calcium oxalate nephrolithiasis are excluded.

Patients with a significant history of malabsorption (e.g. celiac sprue, short bowel syndrome, IBD or other, as determined by the treating physician) are excluded.

Patients will not be eligible if actively receiving treatment for vitamin D deficiency and have had recent (3 month) history of vitamin D supplementation (>1000 IU) or calcium supplementation (>800mg).

The following exclusion criteria will avoid the possibility of preexisting muscle impairment: history of congenital myopathies; neurologic disorder involving sequelae of spinal derangement; disk disease or vascular disease; tremor and rigidity.

Patients will also be excluded if they report lower extremity (LE) surgery or injury to the LE in the past 3 months or a past medical history of primary hyperparathyroidism; or rhabdomyolysis.

Additional exclusion criteria include participation in a scheduled resistance exercise program 1 month;

• metal implants or other contraindications for the MRI;
• diabetes,
• advanced renal disease,
• uncontrolled hypertension;
• a vitamin D status (25(OH)D) of > 32ng/mL.