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Clinical Studies
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“Prescribing” Exercise to Cancer Patients at Risk for Falls
Rochester, Minn.
The purpose of this study is to develop a data-driven approach that enables healthcare providers to “prescribe” exercise in the appropriate dose in a manner analogous to prescribing a drug.
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A Feasibility Double-Blinded, Randomized Study of Educational Materials for Hiccups
Rochester, Minn.
This is a research study about hiccup educational materials. The purpose of this study is to learn whether this type of research can be done and whether patients report that updated educational materials on hiccups are useful. Patients will randomly receive one of two sets of materials on hiccups education. These educational materials will be provided through email. A few weeks after receiving these materials, patients will be contacted to complete a 5-minute follow-up questionnaire over the phone.
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A Phase II Clinical Study of BBI503 in Asymptomatic Recurrent Ovarian Cancer Patients With CA-125 Elevation
Rochester, Minn.
This is an open label, single-arm, phase II study. The study population is adult patients with asymptomatic recurrent ovarian cancer who have an elevation in their CA-125 level.
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A Pilot Randomized, Placebo-Controlled Study to Test Auranofin (Ridaura®) to Control the Paclitaxel-Induced Pain Syndrome (PIAPS)
Rochester, Minn.
This randomized pilot trial studies whether auranofin will relieve pain following paclitaxel in patients who have previously experienced paclitaxel-induced pain. Auranofin is a drug given by mouth to treat other diseases such as rheumatoid arthritis, and is being studied to see if it will decrease pain following paclitaxel.
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A222004, A Randomized Phase III Trial of Olanzapine Versus Megestrol Acetate for Cancer-Associated Anorexia
Rochester, Minn.,
Eau Claire, Wis.,
Albert Lea, Minn.
This phase III trial compares the effects of olanzapine versus megestrol acetate in treating loss of appetite in patients with cancer that has spread to other places in the body (advanced). Olanzapine may stimulate and increase appetite. This study aims to find out if olanzapine is better than the usual approach (megestrol acetate) for stimulating appetite and preventing weight loss.
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Consent Forms in Cancer Research: Examining the Effect of Length on Readability
Rochester, Minn.
The objectives of this study are to determine whether cancer patients report that shorter, or less wordy, consent forms are helpful to them as they decide about whether or not to enroll in a cancer clinical trial, and to determine whether shorter consent forms result in a greater percentage of patients’ enrolling in a cancer clinical trial, based on whether or not the patient has signed a mock consent form.
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Do patients diagnosed with cancer suffer from scan-itis? - A Qualitative Study
Rochester, Minn.
The purpose of this study is to determine what patients experience when they return for scans or other testing during their oncology follow-up visits after their initial cancer diagnosis.
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Double-Blinded, Placebo-Controlled Pilot Trial to Explore Whether Lipids Prevent Carboplatin and Oxaliplatin Hypersensitivity Reactions
Rochester, Minn.
This randomized pilot trial studies how well fat emulsion works in preventing hypersensitivity reactions in patients with cancer receiving carboplatin or oxaliplatin. Giving lipids before chemotherapy may prevent some drug reactions from carboplatin or oxaliplatin.
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Learning from Patients How They Were Educated on Chemotherapy Side Effects
Rochester, Minn.
To learn in patients’ own words how they were educated on chemotherapy side effects, what aspects of that education were most helpful, and what aspects could be done better (and why).
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Loneliness in Cancer Patients: A Qualitative Study
Rochester, Minn.
The purpose of this study is to characterize, using the patients’ own words, the experience of loneliness (or lack of privacy) that may be felt on inpatient units.
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MC1267, A Randomized, Blinded Phase II Placebo-Controlled Trial With Oral Serum Bovine Immunoglobulin (SBI) to Assess Quality of Life and the Faster Post-Operative Recovery of Gynecological Cancer Patients
Rochester, Minn.
This randomized pilot phase II trial studies how well serum bovine immunoglobulin protein isolate works in improving quality of life and post-operative recovery in patients with gynecological cancer after undergoing surgery. Serum bovine immunoglobulin supplementation may improve the quality of life of patients with gynecological cancer.
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MC1512: A Randomized, Double-Blinded, Placebo-Controlled Expansion Cohort Study of Disulfiram and Chemotherapy in Pancreas Cancer Patients
Rochester, Minn.
This partially randomized phase I trial studies the side effects and best dose of disulfiram when given together with gemcitabine hydrochloride in treating patients with a solid tumor that cannot be removed by surgery (unresectable) or pancreatic cancer that has spread to other places in the body (metastatic) and to compare whether disulfiram and gemcitabine hydrochloride may reduce tumor induced muscle loss. Weight loss occurs in pancreatic cancer patients and is common in a multitude of other cancers. Patients with metastatic cancer and weight loss sometimes are not able to receive treatment due to physical weakness or debility. Disulfiram is a potential inhibitor of muscle degradation and may reduce tumor induced muscle wasting. Disulfiram may also help gemcitabine hydrochloride work better by making tumor cells more sensitive to the drug. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet know whether giving gemcitabine hydrochloride with or without disulfiram is a better treatment for unresectable solid tumors or metastatic pancreatic cancer.
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MC1761 Phase II Trial to Evaluate the Efficacy of Auranofin and Sirolimus in Serous Ovarian Cancer Patients with Recurrent Disease
Rochester, Minn.
This phase II trial studies how well auranofin and sirolimus work in treating participants with ovarian cancer. Immunosuppressive therapy, such as auranofin and sirolimus, is used to decrease the body?s immune response and may increase blood cell count.
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MC17C1 Double-Blinded, Placebo-Controlled Trial to Explore the Anti-Androgen, Ketoconazole, for Treating Patients with an Ongoing Epidermal Growth Factor Receptor (EGFR) Inhibitor-Induced Rash
Rochester, Minn.
This early phase I trial studies the side effects of ketoconazole and how well it works in treating participants with ongoing EGFR inhibitor-induced rash. Ketoconazole may reduce the symptoms related to EGFR inhibitor therapy and improve EGFR inhibitor-induced rash.
We would like to see if use of topical ketoconazole will improve rashes in patients with EGFR inhibitor-induced rash.
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Phase 1 Pilot Study of Curcumin and Piperine to Derive a Safe, Optimal Biologic Dose for Ureteral Stent-Induced Symptoms
Rochester, Minn.
Ureteral stents can cause severe symptoms yet are necessary to preserve/improve renal function in patients with malignant ureteral obstruction. Stent-induced symptoms are particularly challenging because the medications commonly used to treat them can spawn unacceptable side effects. These stent-induced symptoms appear to be mediated by prostaglandins, particularly prostaglandin E2. Curcumin, a group of spices derived from turmeric, has been tested in 80+ clinical trials and down-regulates prostaglandin E2 and as well other mediators of inflammation.
We hypothesize that urine prostaglandin E2 can serve as a biologic marker to derive an optimal biological dose of oral curcumin + piperine (the latter improves the bioavailability of the former).
We propose a phase I trial with oral curcumin + piperine in older cancer to derive a safe, optimal biological dose to be tested for stent symptoms in a future randomized phase 2 or 3 cancer cooperative group trial.
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Phase I Trial and Expansion Cohort Study of Tofacitinib and Gemcitabine in Weight-Losing Pancreas Cancer Patients
Rochester, Minn.
The purpose of this study is to test the safety, tolerability and possible benefit of a drug called tofacitinib in patients with metastatic pancreas cancer when given combined with a standard chemotherapy drug called gemcitabine.
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Piloting a Referral System to Address the Educational Needs of Patients with Dexamethasone-Induced Hiccups
Rochester, Minn.
The purpose of this study is to provide descriptive data on hiccup incidence among a group of patients at risk, to provide descriptive data on the percentage of patients who choose to engage in a short educational session on hiccups, and to provide descriptive data on whether patients reported finding this educational session helpful.
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Resistance Training and 1,25 (OH)2D3 Administration to Maintain Respiratory Muscle Function and Reduce Pneumonia Risk in Cancer Patients
Rochester, Minn.
This research is intended to begin to explore the impact of inspiratory muscle resistance exercise and/or 1,25(OH)2D3 for improving respiratory muscle strength in cancer patients (subjects).
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Symptoms from Olaparib: Understanding a Real-World Patient Experience with Qualitative Methodology.
Rochester, Minn.
The purpose of this study is to gather real-world, patient-reported experiences of ovarian cancer patients who have been prescribed olaparib; this experience will be captured in patients’ own words with qualitative research methodology.
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Understanding Hiccups from the Perspective of Patients
Rochester, Minn.
The purpose of this study is to characterize the experiences patients have with hiccups using their own words.
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