Vitamin C Deficiency

Smoking

Surgery

Surgery--Complications

Wound

Wound Complication

Wound Infection

Wound Dehiscence

Wound of Skin

Mandible Fracture

Mandible Open Fracture

Mandible Closed Fracture

Mandibular Fractures

Ascorbic Acid Deficiency

Oxidative Stress

Inflammation

Just after induction of anesthesia in the OR, subjects will be administered a single intravenous (IV) dose of Vitamin C at 66mg/kg/hr for 2 hours during surgery. Post-operatively (beginning the morning after surgery) Vitamin C Treatment Group subjects will receive a 4 week prescription of oral, liquid Vitamin C, 500mg by mouth two times a day. These dosages are known to be safe and effective.89-91

Vitamin C

Subjects will receive IV placebo (normal saline) identically packaged. Post-operatively Placebo Control Treatment Group participants will receive a 4-week prescription of the aqueous solution base used for the treatment group without the active component (Vitamin C).

Placebo

Hennepin Healthcare Research Institute

The Effect of Vitamin C on Wound Healing In Mandibular Fracture Patients

The Effect of Vitamin C on Wound Healing In Mandibular Fracture Patients: A Double Blind, Placebo-controlled Randomized Clinical Trial

Biomarker of soft tissue repair. Measured in picogram/milliliter (pg/ml) in blood serum.

Biomarker of soft tissue repair. Measured in picogram/milliliter (pg/ml) in blood

Biomarker of soft tissue repair. Measured in nanogram/milliliter (ng/ml) in blood

Biomarker of soft tissue repair. Measured in micro Molar uM in blood

Biomarker of soft tissue repair. Measured in nanomol/microliter (nmol/ul) in blood

Biomarker of bone repair. Measured in enzyme unit/liter (U/L) in blood

Biomarker of bone repair. Measured in picogram/milliliter (pg/ml) in blood

Biomarker of bone repair. Measured in nanogram/milliliter (ng/ml) in blood

Vitamin C levels. Measured in nanomols (nmmol) in blood serum

Biomarker of tobacco exposure. Measured in nanograms/milliliter (mg/ml) in blood serum.

Wounds are scored from photographs using the InCISE wound score developed by the investigator.

Regions Hospital

University of Minnesota

Patients receive phenelzine sulfate PO QD on days -7 to -4, and then BID on days -3 to 21. Patients receive docetaxel IV over 60 minutes on day 1. Treatment repeats every 21 days for at least 12 weeks in the absence of disease progression or unacceptable toxicity.

Combination Phenelzine and Docetaxel

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Region of Enrollment

PSA response: A ≥ 30% reduction from baseline within 12 weeks of initiation of therapy (confirmed on a second measurement at least 3 weeks later).

Proportion of Patients Who Experience a PSA (Prostate-Specific Antigen) Decline of at Least 30%

Progression free survival is calculated as the time from Day 1 of Combination therapy to first evidence of progression (by PSA, Measureable Disease, or Clinical Progression). For subjects who did not meet progression criteria, date of new therapy or date of death was used. Outcome is reported as mean.

Patients receive phenelzine sulfate orally (PO) once daily (QD) on days -7 to -4, and then twice daily (BID) on days -3 to 21. Patients receive docetaxel intravenously (IV) over 60 minutes on day 1. Treatment repeats every 21 days for at least 12 weeks in the absence of disease progression or unacceptable toxicity.

Duration of Progression Free Survival After Initiation of Combination Phenelzine and Docetaxel Therapy

Reported as Number of participants with MAOA expression greater than 5%.

Frequency of MAOA (Monoamine Oxidase A) Overexpression in CRPC (Castration-Resistant Prostate Cancer) Tumors That Are Progressing on Docetaxel

HIF-1alpha Expression in CTC (Circulating Tumor Cells) as a Potential Measure of MAO Activity

A Pearson's correlation will be used to correlate tumor biopsy MAOA expression and circulating tumor cells MAOA expression.

MAOA Expression in CTC (Circulating Tumor Cells) and Comparison to Biopsy MAOA Expression

Measured from Day 1 of Combination therapy to PSA at 12 Weeks on therapy (or earlier if subject not on therapy for 12 weeks).

Maximum Change in PSA

Response in measurable disease is defined as a 30% decrease in the sum of diameters of target lesions (as described by RECIST 1.1).

Response Rate in Measurable Disease by RECIST (Response Evaluation Criteria In Solid Tumors) Criteria

Time to death is calculated from Day 1 of Combination therapy to death from any cause.

Time to Death From All Causes

Number of participants who experienced an Adverse Event. Detail of Adverse Events is reported in the Adverse Event Section

Toxicity of the Regimen

Overall Study

Kristi Eilers

Hormone-Resistant Prostate Cancer

Metastatic Prostatic Adenocarcinoma

Prostate Adenocarcinoma

Recurrent Prostate Carcinoma

Undergo transrectal ultrasound (TRUS) guided prostate biopsy OR image-guided (CT or ultrasound) core bone or soft tissue biopsy

lysine/hypoxia

The Effect of Vitamin C on Wound Healing In Mandibular Fracture Patients

Phenelzine Sulfate and Docetaxel in Treating Patients With Prostate Cancer With Progressive Disease After First-Line Therapy With Docetaxel

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