Symptoms and General Pathology

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Recurrence

Breast Neoplasms

Neoplasm Metastasis

Breast Diseases

Skin Diseases

Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks. Patients drink 8 ounces of alkaline water within 30 minutes immediately prior to and after undergoing radiation therapy.

Patients undergo external beam radiation therapy as in arm I. Patients also drink 8 ounces of distilled water within 30 minutes immediately prior to and after undergoing radiation therapy

Patients drink 8 ounces of alkaline water within 30 minutes immediately prior to and after undergoing radiation therapy.

alkaline water

Patients also drink 8 ounces of distilled water within 30 minutes immediately prior to and after undergoing radiation therapy.

distilled water

Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks.

external beam radiation therapy (EBRT)

Charles Kunos, MD

This phase II trial is studying how well alkaline water works in reducing skin toxicity in women with breast cancer undergoing radiation therapy. Alkaline water may reduce radiation therapy-related skin toxicity in patients with breast cancer.

OBJECTIVES:

I. The goal of this two-phase study is to assess the rate of grade 2 or higher radiation-related skin toxicity in adult patients with breast malignancies after administration of alkaline (pH 9.0) or distilled (pH 7.0) water consumed immediately prior to and after daily radiation treatments.

OUTLINE:

FEASIBILITY PHASE: Patients undergo external beam radiation therapy once daily (QD), 5 days a week for 6 weeks. Patients drink 8 ounces of alkaline water within 30 minutes immediately prior to and after undergoing radiation therapy.

INTERVENTION PHASE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks. Patients drink 8 ounces of alkaline water within 30 minutes immediately prior to and after undergoing radiation therapy.

ARM II: Patients undergo external beam radiation therapy as in arm I. Patients also drink 8 ounces of distilled water within 30 minutes immediately prior to and after undergoing radiation therapy.

Treatment continues in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 1 month.

Alkaline Water in Reducing Skin Toxicity in Women With Breast Cancer Undergoing Radiation Therapy

Alkaline Water Consumption to Reduce Skin Radiation Toxicity in Women With Breast Cancer

Information will include the type, severity, time of onset and resolution of its onset, and its probable association with the study regimen. Frequency tables will be constructed to summarize observed incidents by severity and type of toxicity during weekly radiation treatment and 1 month after radiation treatment. Observed toxicity differences among the treatment arms may be reported in frequency tables.

A paired sample t-test (a=0.05) assessing change in urine pH between before treatment day 0 and after radiation and alkaline water treatment day 33.

National Cancer Institute (NCI)

Case Comprehensive Cancer Center

Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks. Patients drink 8 ounces of alkaline water within 30 minutes immediately prior to and after undergoing radiation therapy.

alkaline water: Patients drink 8 ounces of alkaline water within 30 minutes immediately prior to and after undergoing radiation therapy.

external beam radiation therapy (EBRT): Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks.

Arm I: Alkaline Water

Patients undergo external beam radiation therapy as in arm I. Patients also drink 8 ounces of distilled water within 30 minutes immediately prior to and after undergoing radiation therapy

distilled water: Patients also drink 8 ounces of distilled water within 30 minutes immediately prior to and after undergoing radiation therapy.

external beam radiation therapy (EBRT): Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks.

Arm II: Distilled Water

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Dr. Charles A. Kunos, MD, PhD

Acute and Grade 2 or Higher Radiation-related Skin Toxicity as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0

pH at baseline

pH at day 33 of treatment

Only the first ten patients in the alkaline water group, who took part in the safety lead-in portion of the study were analyzed for urine pH

Change in Urine pH

Overall Study

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Urinary Bladder Neoplasms

Disease Attributes

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Antineoplastic Agents

All Drugs and Chemicals

Mitomycins

Mitomycin

the group of patients with superficial bladder cancer in the intermediate risk group who had their first recurrence after 6 months from the initial TUR. We plan to administer 200 ml of distilled water as immediate instillation for 2 hours

we plan to administer 200ml of distilled water after TUR of the tumor and block the catheter for 2 hours

Zafer Kozacioglu, MD

Murat Arslan, MD

Tansu Degirmenci, MD

Fatih Duz, MD

Ali R Ayder, MD

Nukhet Eliyatkin, MD

The purpose of this study is to compare and evaluate the efficacy of distilled water vs Mitomycin C on preventing the recurrences of intermediate risk group recurrent superficial bladder cancer administered as a single dose immediate instillation after complete Transurethral Resection(TUR) of the tumor.

We plan to administer 200ml of distilled water as a single peroperative instillation and block the catheter for 2 hours to our eligible recurrent superficial bladder cancer patients who were in our follow-up schedule since 2002.

We plan to look over the histories of the same patients in terms of the pathologies, recurrence patterns, the presence of peroperative intracavitary therapy after their previous TURs for recurrences.

So we shall compare the effectiveness of MMC and distilled water on reducing the recurrences over the same patient pool.

The patients will be scheduled for a follow-up program after TUR as;

* cystoscopy
* urine cytology
* bladder wash cytology for the probability of recurrence for 2 years to see if there is any difference in the recurrence patterns after instillation with distilled water vs MMC.

Efficacy of Distilled Water Versus Mitomycin C on Preventing Recurrences of Bladder Cancer After Transurethral Resection

The Efficacy of Distilled Water vs Mitomycin C as a Single Dose Immediate Instillation After Transurethral Resection of Intermediate Risk, Recurrent Superficial Bladder Cancer

Bozyaka Training and Research Hospital

Zafer Kozacioglu

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Vasodilator Agents

Platelet Aggregation Inhibitors

Iloprost

Iloprost 10μg of inhaled iloprost (Ventavis®)

Study drug was inhaled to ventilated lung through a nebulized system in inspiratory limb after one-lung ventilation in the lateral decubitus position.

Iloprost 20μg of inhaled iloprost (Ventavis®)

Study drug was inhaled to ventilated lung through a nebulized system in inspiratory limb after one-lung ventilation in the lateral decubitus position.

Distilled water

Study drug was inhaled to ventilated lung through a nebulized system in inspiratory limb after one-lung ventilation in the lateral decubitus position.

Study drug was inhaled to ventilated lung through a nebulized system in inspiratory limb after one-lung ventilation in the lateral decubitus position.

Inhaled iloprost

Distilled water

Wonjung Hwang

During one-lung ventilation in patients undergoing thoracic surgery, the persistent flow in the non-ventilated lung increases intrapulmonary shunt and decreases systemic arterial oxygenation. This prospective, randomized, double blind study was conducted to evaluate the effects of inhaled iloprost during one-lung ventilation on arterial oxygenation and shunt fraction during thoracic surgery.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Alkaline Water in Reducing Skin Toxicity in Women With Breast Cancer Undergoing Radiation Therapy	NCT01487954	Radiation Toxic... Recurrent Breas... Stage I Breast ... Stage II Breast... Stage IIIA Brea... Stage IIIB Brea... Stage IIIC Brea... Stage IV Breast...	alkaline water distilled water external beam r...	18 Years -	Case Comprehensive Cancer Center
Efficacy of Distilled Water Versus Mitomycin C on Preventing Recurrences of Bladder Cancer After Transurethral Resection	NCT00816075	Recurrent Super... Distilled Water	distilled water	-	Bozyaka Training and Research Hospital
Efficacy of Distilled Water Versus Mitomycin C on Preventing Recurrences of Bladder Cancer After Transurethral Resection	NCT00816075	Recurrent Super... Distilled Water	distilled water	-	Bozyaka Training and Research Hospital
The Effect of Iloprost on Oxygenation During One-lung Ventilation for Lung Surgery	NCT03936140	Lung Cancer	Inhaled ilopros... Distilled water	20 Years - 75 Years	Seoul St. Mary's Hospital
The Effect of Iloprost on Oxygenation During One-lung Ventilation for Lung Surgery	NCT03936140	Lung Cancer	Inhaled ilopros... Distilled water	20 Years - 75 Years	Seoul St. Mary's Hospital
The Effect of Iloprost on Oxygenation During One-lung Ventilation for Lung Surgery	NCT03936140	Lung Cancer	Inhaled ilopros... Distilled water	20 Years - 75 Years	Seoul St. Mary's Hospital

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