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NCT ID: NCT00717717 Completed - Cancer Clinical Trials

A Clinical Controlled Trial on the Effect of Physical Activity After Cancer Treatment (PACT)

PACT
Start date: November 2006
Phase: N/A
Study type: Interventional

The PACT Study (Physical Activity after Cancer Treatment) is a unique study within the field of cancer rehabilitation in Denmark. It differs from other studies mainly due to the intervention itself. A combination of physiological, health educational and therapeutic elements will be tested. These components are incorporated into a one-year training program for mixed groups (i.e. men + women, with varying cancer diagnoses) to encourage them to enhance their well.-being and quality of life. The overall aim of this approach is to place increased focus on the treated cancer patient's introduction to and exploitation of both physiological and psychosocial yields through physical exercise. Whether or not the study results bear a positive effect, they are expected to support new knowledge in rehabilitation for cancer survivors.

NCT ID: NCT00716898 Completed - Cancer Clinical Trials

Pharmacokinetics of Low Molecular Weight Heparin in Cancer Patients

Start date: February 2009
Phase: N/A
Study type: Observational

The purpose of the study is to determine the Pharmacokinetics of Low Molecular Weight Heparin (LMWH) in Cancer patients, and compare it to the Pharmacokinetics of LMWH in Patients without cancer. We also intend to detect any correlation between heparanase blood and urine levels and the Pharmacokinetics of LMWH.

NCT ID: NCT00716872 Completed - Cancer Clinical Trials

Improving the Sleep of Cancer Patients Using an Internet-Based Program

SHUTi-C
Start date: July 2008
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether an Internet-based program, Sleep Healthy Using the Internet (SHUTi, or "Shut-Eye"), can help to improve the sleep of people who are in remission from cancer and experiencing symptoms of insomnia.

NCT ID: NCT00710658 Completed - Breast Cancer Clinical Trials

Internet Support for Cancer Patients

WebChoice
Start date: May 2006
Phase: N/A
Study type: Interventional

Cancer patients often experience multiple physical, functional and psychosocial symptoms, but have limited support while being at home between treatments and during rehabilitation. WebChoice is a novel Internet support system that extends traditional health services into patients' homes. The system allows patients to monitor symptoms over time, and provides access to evidence-based self-management options tailored to their reported symptoms as well as a communication area where patients can ask questions to a clinical nurse specialist in cancer care and exchange experiences with other cancer patients. This randomized clinical trial: 1. Tests the effects of WebChoice on primary outcomes of symptom distress, quality of life, depression and health service use, and secondary outcomes of self-efficacy, social support . We will also analyze: 2. Relationships between primary and secondary outcomes; 3. How patients' symptom distress varies over time; 4. Patients' preferences for participation in decision making about symptom management 5. How patients use WebChoice, such as frequency of use, duration, most used components; 6. How patients' experience WebChoice's usefulness and ease of use; 7. Patterns and content of patients' communication with the cancer nurse and other patients. 325 cancer patients (189 breast cancer and 136 prostate cancer patients) were recruited from throughout Norway through advertisements and invitation letters and the Norwegian Cancer Registry. Patients were randomly assigned to WebChoice or the control group that received usual care. Patients are being followed with 5 repeated measures over 12 months. Data are being collected through questionnaires, from system logs, and from interviews that were conducted in subset of experimental group patients. The primary hypothesis will be tested with Repeated Measures ANCOVA techniques. The other research questions will be answered using various inferential and descriptive techniques and through content analysis of messages and transcripts of patient interviews. This study can make a significant contribution to reduce unnecessary suffering and improve the quality of life for a large group of cancer patients.

NCT ID: NCT00709813 Completed - Cancer Clinical Trials

Study to Test a Computer-assisted Support System to Improve Patient-centered Care and Symptom Relief in Cancer Patients

Start date: December 2003
Phase: N/A
Study type: Interventional

Patient-provider shared decision making and the inclusion of patients' illness experiences and preferences in patient care are prioritized areas in health care. CHOICE is a computer-based support system for patient-centered symptom management of cancer patients developed for this purpose. In this randomized clinical trial at Rikshospitalet- Radiumhospitalet HF 145 adult stem-cell transplantation and newly diagnosed lymphoma and leukemia patients used CHOICE for assessments of their symptoms, problems and priorities for care at in-and outpatient visits during treatment and rehabilitation. In the experimental group this information was shared with physicians an nurses for subsequent care planning, but not in the control group. This study tested effects of CHOICE on symptom- related patient care and outcomes of symptom relief, patients' needs for care over time and patient satisfaction;(2) analyzed how patients' symptoms, needs for care varied during illness/treatment stages; and (3) evaluated CHOICE' ease of use and user satisfaction. Controlling for gender, age, diagnosis, and type/stage of treatment, education, depression, health related quality of life, and social support, repeated measurement models were used to test differences and variations in outcome variables within and between groups and over time.

NCT ID: NCT00708877 Terminated - Cancer Clinical Trials

Liver Transplantation for Cholangiocarcinoma

Start date: March 2007
Phase: N/A
Study type: Interventional

Today, available therapies for hilar cholangiocarcinomas (CCA) are not satisfactory. Although these tumors are rare, their study is important because of the high death rates in afflicted patients, rivaling that of pancreatic cancer. Surgical resection offers the only current hope for long-term survival, averaging only 20% in major series1. The reality is such that for the majority of patients, CCA is a diagnosis of despair. Although surgery has offered the only hope of cure, one of the major limiting factors in achieving long-term survival following surgical resection of CCA is the technical ability to achieve negative resection margins. The presence of malignant cells at the surgical margins following resection is a major prognostic factor predicting recurrence and death. Theoretically, the likelihood of achieving negative margins can be increased with total hepatectomy and orthotopic liver transplantation (OLT). Previous experience with OLT performed in isolation for hilar CCA's has been discouraging with dismal survival rates. However, a recent report has demonstrated that long-term survival can occur in carefully selected patients by combining the benefits of radiotherapy, chemosensitization, and OLT. With this strategy, patients survival rates of 92%, 82%, and 82% at 1, 3, and 5 years after transplantation have been achieved. It is not clear that these preliminary results can be confirmed at other centers, nor is it clear what selection criteria should optimally be used for this treatment strategy. Our hypothesis is that select patients undergoing liver transplantation for CCA in the context of multi-modality neoadjuvant therapy exhibit survival equivalent to other established indications for liver transplantation as previously demonstrated. We will also attempt to extend previously published criteria for liver transplantation in the setting of CCA by offering this protocol to patients with evidence of intrahepatic disease and regional nodal disease. Patients undergoing transplantation for CCA will be followed longitudinally for their entire post-transplant course and compared with a matched cohort of liver transplant recipients in regard to post-transplant survival, survival on the waiting list, as well as complications pre-and post-transplantation. Explanted livers will be examined for the presence of residual tumor. Data will be collected on the rate of regional lymph node metastasis, invasion of adjacent organs and tissues, and the rate of peritoneal metastases. The rate of tumor recurrence, site, and time to recurrence will also be assessed.

NCT ID: NCT00708721 Terminated - Cancer Clinical Trials

Low-dose Oral Clofarabine for the Treatment of IPSS INT-1, INT-2 or HIGH Myelodysplastic Syndromes and Chronic Myelomonocytic Leukemia

Start date: March 2008
Phase: Phase 1/Phase 2
Study type: Interventional

Study and Dose Rationale The safety profile of clofarabine appears acceptable within the target populations studied to date in the clinical studies summarized in Section 2.3. clofarabine has demonstrated anti-cancer activity through inhibition of DNA synthesis and repair, induction of apoptosis, and possibly through other mechanisms. The effect of clofarabine on DNA methylation has not been determined. Numerous responses have been observed after treatment with clofarabine in heavily pre-treated relapsed/refractory patients with ALL or AML. Recently 2 small studies were conducted at the M.D. Anderson Cancer Center looking at the use of clofarabine in the treatment of MDS.31 The first study randomized patients in a Bayesian fashion to 15 vs. 30 mg/m2 given IV daily for 5 days every 4 to 8 weeks. In the 15 mg/m2 arm 3 of 7 patients had a complete remission according to the International Working Group (IWG)32 criteria for response. In the 30 mg/m2 arm, 2 of 6 patients had a complete remission while 1 patient had hematologic improvement according to IWG criteria. In the second study, patients were treated with oral clofarabine at a dose of 40 mg/m2 daily for 5 days every 4 to 8 weeks. Two of 7 patients had hematologic improvement according to IWG criteria. The main toxicities in both trials were prolonged myelosuppression and liver function abnormalities. Preclinical animal models have shown increased clofarabine activity against multiple different tumors with repetitive daily dosing for prolonged periods of time.33 The use of an oral therapy is advantageous for the treatment of a chronic malignancy such as MDS. Furthermore, based on the pre-clinical data mentioned above daily repetitive dosing over a protracted period may provide increased efficacy. Since most MDS patients are elderly and may not tolerate aggressive therapy, a schedule of administration of low dose oral clofarabine over a protracted period may provide the advantage of increased efficacy without severe toxicity. The safety of a protracted daily dosage of oral clofarabine in humans has not been determined. The dosing scheme for this study will therefore include a dose escalating phase I component followed by a phase II component. The starting dose will be 5 mg (fixed dose) orally daily for 10 days. This dose will be escalated in cohorts of 3 patients as tolerated up to a maximal dose of 15 mg (fixed dose) orally for 10 consecutive days. Note that at the latter dose a patient will receive a total of 150 mg of clofarabine per cycle, which far lower than the MD Anderson study of oral clofarabine in MDS whereby patients received 200 mg/m2 per cycle. OBJECTIVES: Study Overview The purpose of this study is to determine the efficacy and toxicity of Clofarabine administered orally at a low daily dose for the treatment of myelodysplastic syndromes.

NCT ID: NCT00708448 Completed - Cancer Clinical Trials

Early Prediction of Therapeutic Response to Targeted Therapy in Stage IIIB/IV or Recurrent Lung Cancer Patients

Start date: March 28, 2008
Phase: Phase 1
Study type: Interventional

This exploratory clinical study is designed to obtain pre-therapeutic imaging assessments using positron emission tomography (PET) imaging in 21 patients with Stage IIIB/IV or recurrent non-small cell lung cancer (NSCLC) and an early post therapy assessment at baseline and at various early time points (2 weeks in 7 patients, 4 weeks in 7 patients, and 6 weeks in 7 patients) after institution of erlotinib (anti-EGFR) (Tarceva) and bevacizumab (anti-VEGF) (Avastin) for first-line treatment of Stage IIIB/IV or recurrent non-squamous NSCLC. The proposed PET imaging and blood derived biomarkers trial is a companion study to an approved therapeutic trial (IRB# 24377). The therapeutic trial of erlotinib (Tarceva) and bevacizumab (Avastin) for first-line treatment of Stage IIIB/IV or recurrent lung cancer with drug costs exceeding $150,000 per patient/year (study drug budget exceeds $5 million) was funded for study at the HCI and the HICCP, statewide trial network. The proposed imaging study has been funded by the University of Utah Synergy Grant Program. The clinical imaging biomarkers will include an assessment of tumor metabolism [Banrasch 1986, Frauwirth 2002, Garber 2006, Kelloff 2005, Pauwels 1998, Semenza 2001, Smith 1999, Smith 2000, Sokoloff 1977, Warburg 1956, Weber 1977A, Weber] (dynamic FDG-PET); tumor proliferation [Rasey 2002,Shields 2001,Shields 1998, Vesselle 2002, Schwartz 2003] (dynamic FLT-PET); tumor blood flow and perfusion( H215O-PET)[Lodge 2000]; and tumor blood volume of distribution ( H215O -PET)[Lodge 2000] in the same patient at baseline and then in the same patient at one of the post therapy time points (2 weeks, 4 weeks, or 6 weeks). The investigators hypothesize that by using a set of imaging derived biomarkers and biomarkers from blood they can predict response, either prior to or at an earlier time point than would normally be determined with standard imaging techniques, in patients with lung cancer receiving combined bevacizumab and erlotinib.

NCT ID: NCT00708045 Completed - Cancer Clinical Trials

A Multi-modality Imaging Assessment of Chemobrain

Chemobrain
Start date: May 9, 2007
Phase: Phase 1
Study type: Interventional

Patients must have had their breast cancer treated at the Huntsman Cancer Institute to be eligible for this trial. OBJECTIVES: To use quantitative FDG-positron emission tomography (PET), functional MRI (fMRI) and co-registered anatomic MRI imaging to better understand the cognitive disorder known as "chemobrain" which effects up to 16 -50% of individuals receiving long-term adjuvant chemotherapy [Tannock 2004, Matsuda 2005]. The study is exploratory to obtain proof of feasibility pilot data to support an eventual submission to the NIH. Neuropsychological Testing A battery of testing will be used to assess the subjective complaints of cognitive impairment in the symptomatic patient cohort. Similarly the same battery of tests will be used to assure that the non-symptomatic patient control group and the age-matched normal controls do not exhibit any cognitive impairment. The following set of clinical tests will be performed to assess the degree of cognitive impairment in all subjects.

NCT ID: NCT00708019 Active, not recruiting - Pain Clinical Trials

Improving Cancer Pain Management Through Self-Care

Start date: December 2007
Phase: N/A
Study type: Interventional

This study will test two different doses of a psychoeducational intervention to improve cancer pain management. In addition, the study will determine if the changes in pain management behaviors that the patients and family caregivers learn continue to be used when the intervention stops. It is hypothesized that patients and family caregivers who receive the high dose intervention will have a greater decrease in pain intensity scores.