Charles L. Loprinzi, M.D.

Closed for Enrollment

• A Phase III, Double-Blind, Controlled Trial of Oxybutynin in the Management of Hot Flashes Rochester, Minn.

  This randomized phase III trial studies how well oxybutynin chloride works in managing hot flashes in patients who are not candidates for, or not interested in hormone replacement therapy. Previous studies have shown that oxybutynin is effective in managing hot flashes, however doses used in prior studies have resulted in side effects. This trial is evaluating lower doses of oxybutynin with the goal of determining if they are efficacious with less side effects.

• A Pilot Randomized, Placebo-controlled, Double Blind Study of Venlafaxine to Prevent Oxaliplatin-Induced Neuropathy Rochester, Minn.

  You are being asked to take part in this research study because you are going to be treated with oxaliplatin chemotherapy as part of your standard care. Oxaliplatin commonly causes neuropathy (numbing, tingling and/or pain).The purpose of this study is to compare the effects, good and/or bad, of venlafaxine with a placebo (an inactive agent) on oxaliplatin-induced neuropathy (numbing, tingling and/or pain)

• A Randomized, Phase II Clinical Trial of a Controlled Diet Prior to Selected Chemotherapy Treatment in Breast and Prostate Cancer to Evaluate the Impact on Toxicity and Efficacy Rochester, Minn.

  This randomized phase II trial studies how well a controlled low calorie diet works in reducing side effects and increasing response to chemotherapy in patients with breast or prostate cancer. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Eating a special diet with low calories may reduce the side effects of chemotherapy and improve the response to treatment

• Efficacy and Safety of Rivaroxaban Prophylaxis Compared with Placebo in Ambulatory Cancer Patients Initiating Systemic Cancer Therapy and at High Risk for Venous Thromboembolism Rochester, Minn.

  The purpose of this study is to demonstrate that rivaroxaban is superior to placebo for reducing the risk of lower extremity proximal deep vein thrombosis (DVT), asymptomatic lower extremity proximal DVT, symptomatic upper extremity DVT, symptomatic non-fatal pulmonary embolism (PE), incidental PE, and venous thromboembolism (VTE)-related death in ambulatory adult patients with various cancer types receiving systemic cancer therapy who are at high risk of developing a VTE.

• Efficacy of Rose Geranium in Sesame Oil Nasal Spray for Treating Established Chemotherapy and Targeted Therapy-Related Nasal Vestibulitis Rochester, Minn.

  The purpose of this study is to

  1. Explore the efficacy of rose geranium in sesame oil nasal spray in treating nasal vestibulitis related to cancer-directed therapy.
• Incidence of Chemotherapy and Targeted Therapy-Related Nasal Vestibulitis Rochester, Minn.

  The purpose of this study is to determine the percentage of patients receiving cancer-directed therapy at the Gonda 10 chemotherapy unit who have had or are currently experiencing symptoms of nasal vestibulitis.

• MC15C1 Randomized Scrambler Therapy vs TENS for the Treatment of Chemotherapy-Induced Peripheral Neuropathy Rochester, Minn.

  This randomized clinical trial studies how well MC5-A scrambler therapy or transcutaneous electrical nerve stimulation (TENS) therapy work in treating patients with chemotherapy-induced peripheral neuropathy (a nerve problem that causes pain, numbness, tingling, swelling, or muscle weakness in different parts of the body). MC5-A scrambler therapy is a type of treatment for nerve pain that uses electrodes placed on the skin, where electricity is carried from the electrodes through the skin and blocks the pain. TENS is a procedure in which mild electric currents are applied to some areas of the skin. It is not yet known whether TENS therapy is more effective than MC5-A scrambler therapy in treating chemotherapy-induced peripheral neuropathy.

• MC1893, Nasal Vestibulitis Natural History Evaluation (MC1893) Rochester, Minn., Mankato, Minn., Albert Lea, Minn., Austin, Minn.

  The purpose of this study is to evaluate treatment-emergent nasal vestibulitis symptoms in patients undergoing systemic antineoplastic therapy.

• MC18C1, Prevention of Paclitaxel-associated Neuropathy with Fingolimod: A Pilot Trial (MC18C1) Rochester, Minn.

  The purpose of this study is to determine if the use of Gilenya® can reduce neuropathy caused by paclitaxel.

   

• MC18C2, Treatment of Established Chemotherapy-induced Neuropathy with Fingolimod: A Pilot Trial (MC18C2) Rochester, Minn.

  The purpose of this study is to determine if the use of Fingolimod can reduce neuropathy caused by chemotherapy.

• MC19C1, Rose Geranium in Sesame Oil Nasal Spray as an Agent to Improve Symptoms of Nasal Vestibulitis: A Phase III Double Blinded Randomized Controlled Trial (MC19C1) Rochester, Minn., Albert Lea, Minn., Mankato, Minn.

  This trial will be an evaluation of rose geranium in sesame oil nasal spray versus nasal saline. Rose geranium in sesame oil nasal spray is a compounded preparation, containing 0.2 mL (4 drops) of pharmaceutical grade rose geranium oil to 119.8 mL of pharmaceutical grade sesame oil and then put into 30mL bottles. This is the same compound that was used in the aforementioned study of patients with hereditary hemorrhagic telangiectasia (2). Isotonic nasal saline will contain 0.9% sodium chloride with benzalkonium chloride, as a preservative, in a 30 mL bottle.

   Treatment duration

  The therapy will be given for two weeks. This should give us adequate time to determine whether rose geranium in sesame oil nasal spray can decrease nasal vestibulitis.  Following that two week period, participants taking the saline spray will be allowed to cross over to the other spray. Subjects may cross over within two weeks after completion of treatment and be on therapy for an additional two weeks  such a patient must still be receiving chemotherapy or within 2 weeks of the last chemotherapy dose,  at the time of crossover.

   

• Olanzapine for the Prevention of Chemotherapy Induced Nausea and Vomiting (CINV) in Patients Receiving Highly Emetogenic Chemotherapy (HEC): A Randomized, Double-Blind, Placebo-Controlled Trial Rochester, Minn.

  This randomized phase III trial studies antiemetic therapy with olanzapine to see how well they work compared to antiemetic therapy alone in preventing chemotherapy-induced nausea and vomiting in patients with cancer receiving highly emetogenic (causes vomiting) chemotherapy. Antiemetic drugs, such as palonosetron hydrochloride, ondansetron, and granisetron hydrochloride, may help lessen or prevent nausea and vomiting in patients treated with chemotherapy. Olanzapine may help prevent chemotherapy-induced nausea and vomiting by blocking brain receptors that appear to be involved in nausea and vomiting.

• Olanzapine for the Treatment of Chronic Nausea and/or Vomiting, Unrelated to Chemotherapy or Radiation, in Advanced Cancer Patient - A Pilot, Dose-Finding Trial Rochester, Minn.

  The purpose of this study is to evaluate the use of olanzapine for the treatment of cancer patients with chronic nausea and/or vomiting unrelated to chemotherapy or radiation in a randomized placebo-controlled pilot trial.

• Olanzapine for the Treatment of Chronic Nausea and/or Vomiting, Unrelated To Chemotherapy or Radiation, In Advanced Cancer Patients – A Confirmatory Phase III MNCCTN Trial Rochester, Minn., Mankato, Minn.

  The purpose of this study is to conduct a confirmatory phase III double-blind randomized clinical trial to evaluate the ability of olanzapine to decrease nausea in patients with advanced-cancer associated nausea/vomiting.

• Pilot Clinical Trial Evaluating the Utility of Minocycline as an Agent to Decrease Chemotherapy-Induced Peripheral Neuropathy (CIPN) and Paclitaxel-Induced Acute Pain Syndrome (P-APS): A Randomized Placebo-Controlled, Double Blind Trial Rochester, Minn.

  The purpose of this study is to compare the effects, good and/or bad, of minocycline with placebo (an inactive agent) on symptoms caused by paclitaxel. In this study, the participant will get the minocycline or a placebo starting on the morning of the first dose of chemotherapy and continuing twice a day until a week after chemotherapy is finished.

• Pilot Clinical Trial Evaluating the Utility of Topical Cryotherapy to Decrease Chemotherapy-Induced Peripheral Neuropathy (CIPN) and Paclitaxel-Induced Acute Pain Syndrome (P-APS): A Randomized Controlled Trial Rochester, Minn., Jacksonville, Fla.

  This randomized pilot clinical trial studies topical cryotherapy (a procedure in which an extremely cold liquid is used to freeze and destroy abnormal tissue) in reducing pain in patients with chemotherapy induced peripheral neuropathy or paclitaxel induced acute pain syndrome. Peripheral neuropathy is a nerve problem that causes pain, numbness, tingling, swelling, or muscle weakness in different parts of the body. Paclitaxel produces a disabling syndrome of acute aches and pains. Topical cryotherapy may help relieve pain from peripheral neuropathy or acute pain syndrome caused by chemotherapy.

• Scrambler Therapy for the Treatment of Neuropathy and Pain: An Open Access Trial Rochester, Minn.

  This pilot clinical trial studies scrambler therapy in treating pain and peripheral neuropathy in patients previously treated with chemotherapy. Scrambler therapy may help relieve pain from peripheral neuropathy caused by chemotherapy.

• The Use of Calcium and Magnesium for Prevention of Ixabepilone Induced Peripheral Neuropathy: A Phase III Double-Blind Placebo Controlled Study Rochester, Minn.

  RATIONALE: Giving calcium together with magnesium may stop or delay the development of peripheral neuropathy in patients with cancer who are receiving treatment with ixabepilone. It is not yet known whether calcium and magnesium are more effective than a placebo in preventing peripheral neuropathy caused by ixabepilone.

  PURPOSE: This randomized phase III trial is studying calcium given together with magnesium to see how well it works compared with a placebo in preventing peripheral neuropathy caused by ixabepilone in patients with breast cancer.

• The Use of Glutathione (GSH) for Prevention of Paclitaxel/Carboplatin (TAXOL/CBDCA) Induced Peripheral Neuropathy: A Phase III Randomized, Double-Blind Placebo Controlled Study Rochester, Minn.

  This randomized phase III trial is studying glutathione to see how well it works in preventing peripheral neuropathy caused by paclitaxel and carboplatin in patients with ovarian cancer, fallopian tube cancer, and/or primary peritoneal cancer. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Chemoprotective drugs, such as glutathione, may help prevent peripheral neuropathy caused by paclitaxel and carboplatin. It is not yet known whether glutathione is more effective than a placebo in preventing peripheral neuropathy.

• Treatment of Established Chemotherapy-Induced Neuropathy with N-Palmitoylethanolamide, a Cannabimimetic Nutraceutical: A Randomized Double-Blind Phase II Pilot Trial Rochester, Minn., Eau Claire, Wis.

  The purpose of this study the efectiveness of PEA (N-palmitoylethanolamide) at two different doses relative to placebo responses, as a treatment for chemotherapy-induced neuropathy (CIPN). Also, to assess the safety of PEA at the two study doses, and to evaluate changes in patient-reported symptoms and quality of life from baseline to the end of 8 weeks.