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Breast Cancer clinical trials

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NCT ID: NCT01191164 Not yet recruiting - Breast Cancer Clinical Trials

Pilot Study of Partial Breast Irradiation Utilizing Permanent Breast Seed Implant to Treat Breast Cancer

Start date: September 2011
Phase: N/A
Study type: Interventional

Background: Recent single arm studies have suggested that partial breast irradiation (PBI), delivered in a relatively short overall treatment time of a few days, may be an effective alternative to adjuvant whole breast irradiation (WBI) delivered over a number of weeks. Several PBI modalities and techniques have been investigated, including interstitial brachytherapy and external beam radiation therapy, most often given over the course of one week of twice daily outpatient treatments. One randomized study has shown equivalency between WBI and PBI using brachytherapy. There are currently three large phase-III randomized studies comparing PBI to WBI. Permanent Breast Seed Implant (PBSI) is the newest PBI technique which has been piloted at the Odette Cancer Centre (OCC) in Toronto. The main advantage of this technique is that it requires only one out-patient procedure. The treatment is administered by implanting radioactive Palladium (103Pd) seeds into the tumor bed region in a 1 to ½ hour outpatient procedure, after which the patient is discharged home to resume her normal living activities. This PBI procedure was shown to be well tolerated with minimal acute toxicity. Estimated partner radiation exposure was well within internationally acceptable levels. Subjects with a seroma >2cm were, however, excluded. Hypothesis: PBSI is a feasible, safe, and acceptable treatment option for the subject and her partner in the context of medical practice and resources in BC. Objectives: In subjects who have undergone breast conserving surgery for early breast cancer: 1. To determine the technical feasibility of PBSI in BC 2. To measure the subject's partner in terms of radiation protection 3. To evaluate acceptability of PBSI by the subject 4. To assess resource requirements for PBSI Method: This is a single arm feasibility study. Five women who had undergone breast conserving surgery for breast cancer with low risk of local recurrence will be accrued. This study will adhere to a detailed written protocol for radiation measurements and protection. Subjects will undergo PBSI within 4-14 weeks from last breast surgery. The procedure will be performed in an outpatient setting, under conscious sedation and local anesthesia, by a team with a wide brachytherapy experience. The technique used in this feasibility study will be based on the OCC technique. It is intended that two oncologists and one physicist will spend 2-3 days at the OCC to acquire detailed and firsthand knowledge of the technique as implemented at that centre. The OCC technique is US-based; in this study, however, an additional CT-assisted planning component will be investigated building on the experience of the VIC team which conducted the BC Cancer Agency Vancouver Island Centre's pilot study of CT-based multi-catheter brachytherapy PBI. Systemic therapy will be according to BCCA guidelines; however, subjects requiring adjuvant chemotherapy will be excluded from this study. Subjects will be followed prospectively for 5 years for evaluation of toxicity, QOL and cosmesis. Disease status will be recorded. Relevance: Completing adjuvant breast irradiation with a single out-patient treatment could significantly improve QOL and convenience for patients choosing breast conserving therapy. Confirming the technical feasibility and safety of PBSI is needed before progressing to larger prospective evaluation of this novel adjuvant radiation therapy technique as a viable treatment option for women in British Columbia.

NCT ID: NCT01089699 Not yet recruiting - Breast Cancer Clinical Trials

A Trial Testing Professional and Peer-led Support Online Support Groups for Young Canadian Breast Cancer Survivors

CBCRA09
Start date: April 2010
Phase: Phase 0
Study type: Interventional

Young women who have finished treatment for breast cancer regularly report a lack of psychological and social support in their lives. They often continue to struggle with survivorship issues such as ongoing distress and the challenge of how to rebuild their lives after treatment. This experiment will compare two online support group (OSG) options to determine if both forms of support help young breast cancer survivors adjust, by reducing treatment-related intrusions and helping women re-engage in valued activities and commitments. It will also test if these 2 types of OSG's help womens' mood, feelings of loneliness, confidence, and overall life satisfaction. It will explore the processes within support groups that help to create positive change for young women after cancer treatment. Previous work by this team in a smaller study has shown that online support groups led by professional counselors can be carried out over the Internet, and that they produce helpful benefits for young women survivors of breast cancer. The online groups were comprised of 10 sessions of real time chats, with each session focused on a specific topic. Participants were provided with an educational manual designed to improve skills for coping after cancer, and they were instructed to read one chapter a week in preparation for the chats. The women enjoyed the groups and 3 months after completing the groups, they reported improved quality of life, lower emotional distress, and enhanced coping. However, a large study to determine the strength and reliability of these early promising findings is needed. The questions to be examined are whether trained peers (other young breast cancer survivors) might be able to facilitate the online groups and provide similar positive benefits for young breast cancer survivors, and what facilitators can do to maximize positive benefits in online support groups. This is a multi-provincial, 3-arm study that will compare a professionally-led OSG (with an educational manual) and a peer-led OSG (with an education manual) with a group that just receives the educational manual. Psychological assessment measures given immediately following the 12 week group, and at 6 months and 12 months follow-up, will determine if one or both of the study groups effectively improve quality of life, reduce distress, and enhance self-efficacy and life satisfaction for young breast cancer survivors. Additionally, tests will be performed to investigate whether discussing emotional matters predicts greater improvements.

NCT ID: NCT01071109 Not yet recruiting - Breast Cancer Clinical Trials

The Clinical and Biochemical Effect of Therapeutic Massage on Fatigue and Insomnia in Women With Breast Cancer Receiving Radiation Therapy

RTTM301
Start date: November 2010
Phase: N/A
Study type: Interventional

A majority of women with breast cancer receive radiation therapy, and many of them experience the debilitating side effects of fatigue and insomnia. There is a need for an effective treatment that could ameliorate these symptoms and improve quality of life in the radiation therapy population. The primary purpose of the proposed research is to study the impact of massage therapy as a tool for the management of fatigue and insomnia experienced by women diagnosed with breast cancer and receiving radiation therapy. The secondary purpose is to explain, at the biochemical level, the effect of therapeutic massage on the level of fatigue and insomnia in radiation therapy patients. Prior studies have shown an association between fatigue and insomnia in the breast cancer patient following radiation therapy and the presence of inflammation as evidenced by increased proinflammatory cytokine production. The investigators hypothesize that therapeutic massage will ameliorate the symptoms of fatigue and insomnia associated with radiation therapy, and will be associated with a reduction in the plasma levels of interleukin-6 (IL-6),soluble IL-6 receptor (sIL-6R/CD126), and C-Reactive Protein (CRP). This reduction in proinflammatory biomarkers will be due to the activation of the cholinergic anti-inflammatory pathway via the activation of the vagus nerve.

NCT ID: NCT01043055 Not yet recruiting - Breast Cancer Clinical Trials

Evaluation the Diagnostic Ability of the Cancer Detection Technology (CDT) to Detect Breast Cancer Among Women Population Over Age 40

Start date: January 2010
Phase: N/A
Study type: Observational

This study aimed to validate the diagnostic ability of the CDT (cancer detection technology) software to detect breast cancer among women population.

NCT ID: NCT01038908 Not yet recruiting - Breast Cancer Clinical Trials

Breast Lymph Node Mapping

Start date: June 2013
Phase: Phase 2
Study type: Interventional

The purpose of this study is to map the arm lymphatic drainage system in the axilla with blue dye and the breast drainage system with a radioactive material. By identifying the arm lymphatics they can be protected during surgery and this may decrease the occurrence of lymphedema. The information obtained in this study may provide us with better surgical techniques to identify and protect the arm lymphatic drainage system in the axilla.

NCT ID: NCT01018719 Not yet recruiting - Breast Cancer Clinical Trials

Evaluation of Radiation Induced Toxicity to the Heart by Multi-detector Computed Tomography (MDCT)

Start date: January 2010
Phase: N/A
Study type: Observational

The current study is aimed to evaluate various imaging methods, including multidetector computed tomography (MDCT) as potential surrogates to assess the degree of damage caused to the heart by radiation therapy to the breast, in breast cancer survivors many years before it becomes clinically apparent.

NCT ID: NCT01016574 Not yet recruiting - Breast Cancer Clinical Trials

Evaluating the Adequacy of Giro-Couch to Support Prone Breast Boost Irradiation Using IMRT Technique With IGRT.

IN902
Start date: December 2011
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the Giro-couch, an innovative patient support device for the application of prone RT for treatment of breast cancer. This study will assess the feasibility of a new positioning approach to facilitate the delivery of external beam, delivered to the lumpectomy cavity, (the boost dose, partial breast therapy).

NCT ID: NCT01004796 Not yet recruiting - Breast Cancer Clinical Trials

Study of Biomarkers in Tissue Samples From Patients With Breast Cancer

Start date: n/a
Phase: N/A
Study type: Observational

RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. PURPOSE: This research study is looking at tissue samples from patients with breast cancer.

NCT ID: NCT00910884 Not yet recruiting - Breast Cancer Clinical Trials

Plant Extracted Natural Compounds Impact on Stage IV Breast Cancer Survival Time and Remission.

Start date: September 2020
Phase:
Study type: Observational

RATIONALE: Plant extracted natural compounds, in an adjunct therapy position, slow the growth and reproduction of Stage IV Breast Cancer tumor cells. May help eradicate different types of cancers. PURPOSE: The purpose of this randomized Phase I trial is to first IDENTIFY, through laboratory analysis and validating cellular biochemical pathways, and HELP CONTROL, using natural plant extracted compounds, G.R.A.S. (Generally Accepted As Safe), compounds, the reproduction, growth progress and metastasis of Stage IV Breast Cancer cells. The therapy position is adjunct to conventional therapies and in "one-off" trials have been excitingly effective for long-term survival. Novel use of bioactive GRAS compounds to augment and enhance conventional cancer therapies and as stand-alone parallel therapies.

NCT ID: NCT00688337 Not yet recruiting - Breast Cancer Clinical Trials

Correlation Between Fluorodeoxyglucose (FDG) and FLT Uptake and Gene-Expression Oncotype Assay in Patients With Breast Cancer

Start date: June 2008
Phase: N/A
Study type: Observational

In the current study FDG (Fluorodeoxyglucose) uptake, FLT uptake (F18-Fluoro-3'-deoxythymidine) and their ratios will be correlated with the risk score results of the Oncotype gene-expression assay in patients with clinically negative nodal disease planned for surgical removal of the tumor.