One capsule contains 2.5 billion CFU of Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14.

Placebo. It is the same composition as the active capsule, without the bacteria.

Breast Cancer Female

Participants will take the probiotic or placebo daily for 90 days.

Probiotic Natural Health Product - RepHresh Pro-B

Placebo

St. Joseph's Health Care

Probiotics and Breast Health

Re-setting the Breast Microbiome to Lower Inflammation and Risk of Cancer.

The diversity of the breast microbiota analysed using next-generation sequencing.

Blood samples will be testing by luminex for inflammatory cytokine/chemokine markers.

Urine and blood will be tested for heavy metals using LC-MS.

Urine and blood will be tested for pesticides using LC-MS.

Muriel Brackstone

Principal Investigator

Lawson Health Research Institute

Double blind randomized, placebo-controlled pilot trial.

Patients receive topical urea/lactic acid-based cream applied to palms and soles twice daily and oral pyridoxine once daily on days 1-21.

Patients receive topical urea/lactic acid-based cream as in arm I (closed to accrual as of 10/24/2007) and oral placebo once daily on days 1-21.

Patients receive placebo cream applied to palms and soles twice daily and pyridoxine as in arm I (closed to accrual as of 10/24/2007).

Patients receive placebo cream as in arm III and oral placebo as in arm II (closed to accrual as of 10/24/2007).

Patients receive topical urea/lactic acid-based cream applied to palms and soles twice daily on days 1-21.

Patients receive placebo cream applied to palms and soles twice daily on days 1-21.

Urea/Lactic Acid Cream

Placebo Cream

Total

Age, Customized

Sex: Female, Male

Region of Enrollment

A patient self-reported hand-foot syndrome (HFSD), also known as palmar-plantar erythrodysesthesia, was completed daily while applying the cream. Patients rated skin severity symptoms individually in their hands and in their feet. Definitions of symptoms, which were based on Common Terminology Criteria for Adverse Events (CTCAE) v3.0, were provided to patients. The number of patients reporting moderate to severe symptoms in either hands or feet were tabulated and percentages are reported.

Patients receive topical urea/lactic acid-based cream applied to palms and soles twice daily.

Patients receive placebo cream applied to palms and soles twice daily.

To Determine Whether the Prophylactic Use of a Topical Urea/Lactic Acid Cream Can Decrease the Incidence/Severity of Capecitabine-caused Palmar-plantar Erythrodysesthesia

Frequency and severity of adverse events reported by patients in weekly diary and evaluated through clinical assessment by NCI CTCAE v3.0. The number of patients reporting grade 3 or higher events are reported in this outcome measure. For a full list of all events, please refer to the Adverse Events section of this report.

To Evaluate the Potential Toxicity of Urea/Lactic Acid Cream

A patient self-reported hand-foot syndrome diary (HFSD) was completed daily while applying the cream. Patients rated skin severity symptoms individually in their hands and in their feet. Definitions of symptoms, which were based on Common Terminology Criteria for Adverse Events (CTCAE) v3.0, were provided to patients. The number of patients reporting moderate to severe symptoms were tabulated and percentages are reported.

Arm I: (Urea/Lactic Acid +Vit B6)

Arm II: (Urea/Lactic Acid + Placebo)

Patients receive placebo cream applied to palms and soles twice daily and pyridoxine as in Arm I

Arm III: (Placebo +Vit B6)

Patients receive placebo cream and oral placebo.

Arm IV: (Placebo + Placebo)

Arm V: Urea/Lactic Acid

Arm VI: (Placebo)

Determine Whether the Prophylactic Use of Vitamin B6 Can Decrease the Incidence and/or Severity of Capecitabine-caused Palmar-plantar Erythrodysesthesia (HFSD).

Patients receive placebo cream applied to palms and soles twice daily and pyridoxine as in arm I.

Patients receive placebo cream as in arm III and oral placebo as in arm II.

Evaluate the Potential Toxicity of Vitamin B6.

A patient self-reported hand-foot syndrome diary (HFSD) was completed daily while applying the cream. Patients rated skin severity symptoms individually in their hands and in their feet. Definitions of symptoms, which were based on Common Terminology Criteria for Adverse Events (CTCAE) v3.0, were provided to patients. The number of patients reporting moderate to severe symptoms were tabulated.

Patients receive topical urea/lactic acid-based cream as in arm I (closed to accrual as of 10/24/2007) and oral placebo once daily on days 1-21.
urea/lactic acid-based topical cream: Applied topically
placebo: Given orally or applied topically

Determine Whether the Prophylactic Use of a Topical Urea/Lactic Acid Cream in Combination With Vitamin B6 Can Decrease the Incidence and/or Severity of Capecitabine Caused Palmar-plantar Erythrodysesthesia.

Overall Study

Charles Lawrence Loprinzi, M.D.

Breast Cancer

Drug/Agent Toxicity by Tissue/Organ

Unspecified Adult Solid Tumor, Protocol Specific

pyridoxine hydrochloride

urea/lactic acid-based topical cream

placebo

Mayo Clinic Scottsdale

Aurora Presbyterian Hospital

Boulder Community Hospital

Penrose Cancer Center at Penrose Hospital

St. Anthony Central Hospital

Porter Adventist Hospital

Presbyterian - St. Luke's Medical Center

St. Joseph Hospital

Rose Medical Center

CCOP - Colorado Cancer Research Program

Swedish Medical Center

St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center

North Colorado Medical Center

Sky Ridge Medical Center

Hope Cancer Care Center at Longmont United Hospital

McKee Medical Center

St. Mary - Corwin Regional Medical Center

North Suburban Medical Center

Exempla Lutheran Medical Center

Memorial Cancer Institute at Memorial Regional Hospital

Mayo Clinic - Jacksonville

Rush-Copley Cancer Care Center

St. Joseph Medical Center

Graham Hospital

Memorial Hospital

Eureka Community Hospital

Galesburg Clinic, PC

Galesburg Cottage Hospital

Mason District Hospital

Hopedale Medical Complex

Joliet Oncology-Hematology Associates, Limited - West

McDonough District Hospital

Trinity Cancer Center at Trinity Medical Center - 7th Street Campus

BroMenn Regional Medical Center

Community Cancer Center

Community Hospital of Ottawa

Oncology Hematology Associates of Central Illinois, PC - Ottawa

Cancer Treatment Center at Pekin Hospital

Proctor Hospital

CCOP - Illinois Oncology Research Association

Oncology Hematology Associates of Central Illinois, PC - Peoria

Methodist Medical Center of Illinois

OSF St. Francis Medical Center

Illinois Valley Community Hospital

Perry Memorial Hospital

St. Margaret's Hospital

Carle Cancer Center at Carle Foundation Hospital

CCOP - Carle Cancer Center

St. Francis Hospital and Health Centers - Beech Grove Campus

Elkhart General Hospital

Howard Community Hospital

Saint Anthony Memorial Health Centers

Reid Hospital & Health Care Services

CCOP - Northern Indiana CR Consortium

Memorial Hospital of South Bend

Saint Joseph Regional Medical Center

South Bend Clinic

McFarland Clinic, PC

Cedar Rapids Oncology Associates

Mercy Regional Cancer Center at Mercy Medical Center

Mercy Capitol Hospital

CCOP - Iowa Oncology Research Association

John Stoddard Cancer Center at Iowa Methodist Medical Center

Medical Oncology and Hematology Associates at John Stoddard Cancer Center

Medical Oncology and Hematology Associates at Mercy Cancer Center

Mercy Cancer Center at Mercy Medical Center - Des Moines

John Stoddard Cancer Center at Iowa Lutheran Hospital

McCreery Cancer Center at Ottumwa Regional

Siouxland Hematology-Oncology Associates, LLP

Mercy Medical Center - Sioux City

St. Luke's Regional Medical Center

Cancer Center of Kansas, PA - Chanute

Cancer Center of Kansas, PA - Dodge City

Cancer Center of Kansas, PA - El Dorado

Cancer Center of Kansas-Independence

Cancer Center of Kansas, PA - Kingman

Southwest Medical Center

Cancer Center of Kansas, PA - Newton

Cancer Center of Kansas, PA - Parsons

Cancer Center of Kansas, PA - Pratt

Cancer Center of Kansas, PA - Salina

Cancer Center of Kansas, PA - Wellington

Associates in Womens Health, PA - North Review

Cancer Center of Kansas, PA - Medical Arts Tower

Cancer Center of Kansas, PA - Wichita

CCOP - Wichita

Via Christi Cancer Center at Via Christi Regional Medical Center

Cancer Center of Kansas, PA - Winfield

Hickman Cancer Center at Bixby Medical Center

Saint Joseph Mercy Cancer Center

CCOP - Michigan Cancer Research Consortium

Oakwood Cancer Center at Oakwood Hospital and Medical Center

Green Bay Oncology, Limited - Escanaba

Genesys Hurley Cancer Institute

Hurley Medical Center

Van Elslander Cancer Center at St. John Hospital and Medical Center

Dickinson County Healthcare System

Foote Memorial Hospital

Pyridoxine and Topical Urea/Lactic Acid-Based Cream in Preventing Hand-Foot Syndrome in Patients Receiving Capecitabine for Breast Cancer or Other Cancer

A Phase III Randomized, Placebo-controlled, Double-blind Trial to Determine the Effectiveness of a Urea/Lactic Acid-Based Topical Keratolytic Agent and Vitamin B-6 for Prevention of Capecitabine-Induced Hand and Foot Syndrome

lactic acid/рак на гърдата

Probiotics and Breast Health

Pyridoxine and Topical Urea/Lactic Acid-Based Cream in Preventing Hand-Foot Syndrome in Patients Receiving Capecitabine for Breast Cancer or Other Cancer

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