Participants will engage in three center-based exercise sessions each week for 12 weeks; each session lasting roughly 1-hour. Participants will be given a fitbit (electronic watch that measures steps or heart rate) as well to track heart rate and monitor activity throughout the study.

Participants will not participate in the creatine intervention (creatine supplementation). Participants will engage in three center-based exercise sessions each week for 12 weeks; each session lasting roughly 1-hour. Exercise sessions will be held by trained study staff held at the Medical Arts and Research Center Physical Therapy clinic (address listed above).

Breast Cancer

Chemotherapy Effect

Muscle Weakness

Muscle Loss

Exercise

Those randomized to receive creatine (experimental group) will be initially dosed at 20 g/day for 7 days to boost availability of creatine systemically. Thereafter, the dose will be reduced to 5 g/day for maintenance through the duration of the 12-week protocol.

Creatine

Effects of Creatine Supplementation in Breast Cancer Survivors

The THRIVE Study: An Open-Label Randomized Trial of Exercise ± Creatine Supplementation to Augment the Adaptations of Exercise Training in Breast Cancer Survivors

Participants will be evaluated for knee extensor strength via isometric maximum voluntary contraction at approximately 60° knee flexion.

Functional exercise capacity will be assessed via the 6 minute walk test (6MWT).

Muscle Creatine, Phosphocreatine, and Adenosine-triphosphate content will be assessed in vivo by 31P-MRS using a whole body 3.0T MRI scanner.

Magnetic resonance imaging will be used to capture the mid-thigh cross section.

Darpan Patel

Associate Professor/Research

The University of Texas Health Science Center at San Antonio

This study plans to enroll 30 breast cancer patients who have completed chemotherapy within 6 months prior to consenting for this study. Patients eligible to participate in this study will be allocated to either the creatine group or the control group (1:1) based on a pre-determined randomization list. Each arm will have 15 participants. One arm will receive creatine and the other will serve as the control group with no creatine.

Postmenopausal Symptoms

Vaginal Dryness

Calmera-Licorice Root Extract (Licogen)

Rabin Medical Center

Effectiveness of Licorice Extract Dietary Supplement on the Treatment of Postmenopausal Symptoms

This outcome will be measured by:
a diary in which she should report daily. The reporting would be for 3 parameters: number of hot flushes per day, wakefull night episodes and nocturnal sweating measured by Greens Climateric Scale

this objective will be measured by Pap Smear, Vaginal Ultra sound and vaginal PH

Nir Kedem

F&C Licorice Ltd

Standard doxorubicin and cyclophosphamide (AC) followed by weekly paclitaxel (80 mg/m^2) x 12 with concurrent standard dose trastuzumab (weekly x 12, then repeat 3 weeks for an additional 9 months) plus daily lapatinib (modified to 750 mg during Paclitaxel + Trastuzumab + Lapatinib (PTL) and 1000 mg during trastuzumab + lapatinib (TL)) for a total of 12 months.

AC/PTL

Sex: Female, Male

Race (NIH/OMB)

Region of Enrollment

Performance Status Grade:
0=Fully active, able to carry on all predisease activities without restriction (Karnofsky 90-100); 1=Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light housework, office work (Karnofsky 70-80).

Eastern Cooperative Oncology Group (ECOG) performance status

T Stage

N0=Node negative (either by negative sentinel node or by axillary dissection); N1=Node positive (axillary nodal dissection with 1-3 + nodes); N2=Node positive (axillary nodal dissection with 4-9 + nodes); N3=Node positive (axillary nodal dissection with 10+ nodes); SLN+ refers to Positive Sentinel Node

Nodal Status

Hormonal Status

FISH Amp/IHC refers to fluorescence in situ hybridization amplification/immunohistochemistry

HER2 Status - Positive

Left Ventricular Ejection Fraction (LVEF) Measurement

Smoking status

Current use of hypertensive medication

History of diabetes

Menopausal status

Education level

Number of Patients With Congestive Heart Failure (CHF) While on Active Treatment

Maximum grade for each type of adverse event will be recorded for each patient.

Adverse Event Profile as Measured by NCI CTCAE v 3.0

Evaluable patients included those completed the AC phase of their treatment regimen; with post AC cardiac evaluation indicates they are eligible to begin treatment with PTL; and those have begun their post-AC therapy.
Cardiac events: symptomatic congestive heart failure (CHF), cardiac death and other cardiac events (NCI Common Terminology Criteria for Adverse Events (CTCAE) Grade >=3)

Cumulative Incidence (CI) of Cardiac Events

Number of Patients Who Experience >= 10 Percent Drop in Left Ventricular Ejection Fraction (LVEF) Between Two Time Points

DFS was defined as the time from registration to the earliest date of documentation of any local, regional, or distant recurrence of breast cancer (BC); the development of a contralateral BC or second primary other than squamous or basal cell carcinoma of the skin, carcinoma in situ of the cervix, or lobular carcinoma in situ of the breast; or death from any cause without the documentation of one of these events. Participants were followed for a maximum of 5 years from randomization. The median OS with 95%CI was estimated using the Kaplan Meier method.

Disease-free Survival (DFS)

OS was defined as the time from registration to death of any cause. Participants were followed for a maximum of 5 years from randomization. The median OS with 95%CI was estimated using the Kaplan Meier method.

Overall Survival (OS)

Comparison of Selected Quality-of-life Questionnaires

Quality-of-life

Pulmonary events to be included were grade 3 and higher pulmonary adverse events at least possibly related to study treatment, which occur at any time after post-AC treatment is begun, but prior to documentation of a breast cancer recurrence, contralateral breast cancer, secondary primary cancer, non-pulmonary death, or pulmonary death not related to study treatment.

Incidence of Pulmonary Events

Overall Study

Dr. Edith A. Perez

Cardiac Toxicity

trastuzumab

cyclophosphamide

doxorubicin hydrochloride

lapatinib ditosylate

paclitaxel

gene expression analysis

reverse transcriptase-polymerase chain reaction

fluorophotometry

laboratory biomarker analysis

mass spectrometry

adjuvant therapy

quality-of-life assessment

Mayo Clinic Cancer Research Consortium

Doxorubicin and Cyclophosphamide Followed By Trastuzumab, Paclitaxel, and Lapatinib in Treating Patients With Early-Stage HER2-Positive Breast Cancer That Has Been Removed By Surgery

Phase II Study of Cardiac Safety and Tolerability of an Adjuvant Chemotherapy Plus Trastuzumab With Lapatinib in Patients With Resected HER2 + Breast Cancer

creatine/krūties vėžys

Effects of Creatine Supplementation in Breast Cancer Survivors

Effectiveness of Licorice Extract Dietary Supplement on the Treatment of Postmenopausal Symptoms

Doxorubicin and Cyclophosphamide Followed By Trastuzumab, Paclitaxel, and Lapatinib in Treating Patients With Early-Stage HER2-Positive Breast Cancer That Has Been Removed By Surgery

Išsamiausia vaistinių žolelių duomenų bazė, paremta mokslu