Postmenopausal breast cancer survivors undergoing tamoxifen treatment, who will do the evaluations before the beginning and after 12 weeks of exercise training and subsequently 12 weeks of detraining.

Breast Neoplasm Female

The exercise training program will last 12 weeks, with a frequency of three sessions per week, held on Mondays, Wednesdays, and Fridays. Each session will last approximately 50 minutes. Whenever the maximum number of pre-established repetitions is successfully performed, the intensity will be increased by 5 to 10%. All sessions will be supervised by trained professionals.

Resistance exercise training

The exercise detraining will last 12 weeks without exercise.

Exercise detraining

Guilherme Morais Puga

Effects of Training and Detraining on Postmenopausal Breast Cancer Survivors

Effects of Training and Detraining on Body Composition and Inflammatory, Oxidative and Lipid Profiles of Postmenopausal Breast Cancer Survivors Undergoing Tamoxifen Treatment

Blood samples will be collected after 8-10 hours overnight fasting directly in evacuated tubes containing separator gel. After centrifugation for 10 min at 3000 rpm, the serum will be separated for immediate analysis or stored at -80 °C for further analysis. Serum levels of IL-4, IL-6, IFN-γ, TNF-α and Adiponectin will be determined by enzyme-linked immunosorbent assays (ELISA) using commercial kits (BD Biosciences, San Jose, CA, USA), according to the manufacturer's instructions, in an Immulite 2000 analyzer (BD Biosciences, San Jose, CA, USA). Expressed in pg/mL.

Blood samples will be collected after 8-10 hours overnight fasting in evacuated tubes containing separator gel. After 10 min centrifugation at 3000 rpm, the serum will be stored at -80 °C for further analysis. Lipid peroxidation was estimated by determining the serum concentration of thiobarbituric acid reactive substances (TBARS). The TBARS concentration will be obtained by spectrophotometric reading at 535 nm and interpolation in a malondialdehyde calibration curve. Oxidative damage to serum proteins will be estimated by determining the concentration of carbonylated proteins by reading the absorbance at 370 nm and using the molar absorptivity coefficient of 22.000 M-1cm-1. The levels of non-protein thiols will be obtained by the colorimetric method based on the reaction of the sulfhydryl group with 5,5'-dithiobis (2-nitrobenzoic acid) (DTNB). Expressed in mmol/L.

Blood samples will be collected after 8-10 hours overnight fasting directly in evacuated tubes containing separator gel. After centrifugation for 10 min at 3000 rpm, the serum will be separated for immediate analysis or stored at -80 °C for further analysis.Catalase (Cat) activity was evaluated by the ability of this enzyme to convert H2O2 into O2 and H2O. Expressed in K/gHb.s.

Blood samples will be collected after 8-10 hours overnight fasting directly in evacuated tubes containing separator gel. After centrifugation for 10 min at 3000 rpm, the serum will be separated for immediate analysis or stored at -80 °C for further analysis. The activity of superoxide dismutase (SOD) was evaluated based on their ability to inhibit pyrogallol auto-oxidation and promote a decline in absorbance at 420 nm over time. Expressed in U/gHb.

Blood samples will be collected after 8-10 hours overnight fasting directly in evacuated tubes containing separator gel. After centrifugation for 10 min at 3000 rpm, the serum will be separated for immediate analysis or stored at -80 °C for further analysis. The serum levels of triglycerides (TGC), total cholesterol (t-C), high-density lipoprotein cholesterol (HDL-C) and low-density lipoprotein cholesterol (LDL-C) will be determined using commercial kits (Labtest, Lagoa Santa, MG, Brazil) in a Technicon RA-XT biochemical analyzer (Bayer, New York, NY, USA). Expressed in mg/dL.

The test of one-repetition maximum (1-RM) was adopted to assess muscle strength in all exercises, except for abdominal exercise on the ground, which will be performed only with body mass. Before each test, the subjects will perform a general warm-up (3-5 minutes of light activity), followed by dynamic stretches also for the muscles involved. Then, the participants will perform a specific set of warm-ups that consisted of 8 repetitions with approximately 50% of the estimated load for 1-RM, followed by 3 repetitions with 70% of the estimated load for 1-RM. Subsequently, the loads will be progressively increased until the 1-RM load was found. Rest intervals of approximately 4 to 5 minutes will be inserted between each attempt and the result will be considered valid when performed properly, in a controlled manner, and without assistance from the researchers involved in the assessment. The number of attempts to determine such values will be not more than five. Expressed in kg.

Fat mass (FM) and lean mass (LM) will be measured using a tetrapolar bioimpedance analyzer (InBody230™, Seoul, Korea). Expressed in kg.

Fat mass percentage (BF%) will be measured using a tetrapolar bioimpedance analyzer (InBody230™, Seoul, Korea).

Height was measured in a stadiometer with 0.1 cm accuracy and total body mass was measured using a balance with 0.1 kg accuracy. Body mass index will be calculated using the formula: body mass/height². Expressed in kg/m².

Igor Moraes Mariano

Principal Investigator

Federal University of Uberlandia

At baseline and 6-mo after, a nutrition diagnosis will be done by measuring body composition components with DXA and basic anthropometric measurements. Based on the results, an individualized food-based intervention will be prescribed for each patient according to her diagnosis, food preferences, cultural and socioeconomic status. Follow-up will be every 2-weeks and a different diet menu will be provided in each session by a specialized dietitian, unto 6-mo are completed and initial measurements are repeated.

Breast Neoplasm

Breast Cancer

Diet plans and recommendations will be based on the individual's nutritional status, symptoms and treatment side-effects, socioeconomic and cultural preferences; as well as the WCRF/AICR guidelines adapting 1.5g/kg/d of dietary protein and when required, a caloric restriction (500-1000 kcal/d). Garlic and cruciferous vegetables will be encouraged as well as 5-9 servings of fruits and vegetables a day. The program will be based on the macronutrient meal-equivalent menu method, and standard food servings will be based on the Mexican Food Equivalent System. Breast cancer patients follow-up will be every 2-weeks and a different diet menu will be provided in each session by a specialized dietitian, unto 6-mo are completed.

Individualized food-based intervention

Centro de Investigacion en Alimentacion y Desarollo (CIAD)

Effect of a Clinical Nutrition Intervention Program in Breast Cancer Patients During Antineoplastic Treatment

Effect of a Clinical Nutrition Intervention Program on Body Composition, Metabolism and Antioxidant Activity Associated With Micronutrients in Breast Cancer Patients During Antineoplastic Treatment

change in skeletal muscle mass (kilograms)

change in waist circumference (centimeters)

change in glutathione peroxidase concentration (ng/mL)

change in superoxide dismutase concentration (ng/mL)

change in IL1A, IL1B, IL2, IL4, IL6, IL8, IL10, IL12, IL17A, IFNg, TNFa, and GM-CSF (pg/mL)

Humberto Francisco Astiazaran Garcia, PhD

Director Department of Nutrition

Masking during data analysis. Technicians and investigators will not be aware of the participants personal data and particularities.

Epirubicin 90 mg/m2 and cyclophosphamide 600mg/m2 IV every 3 weeks for 4 cycles.
Nab paclitaxel 125mg/m2 IV days 1, 8 and 15 for 12 weeks In case of HER2 positive tumour patients will receive trastuzumab in combination with nab-Paclitaxel

Nab-Paclitaxel- 125 mg/m2 days 1,8, 15 for 12 weeks

Nab-Paclitaxel

Bankstown Lidcome Hospital

Royal North Shore Hospital

Barwon Health

St John of God Healthcare, Geelong

South West Healthcare

IST Neoadjuvant Abraxane in Newly Diagnosed Breast Cancer

Tailored Neoadjuvant Epirubicin and Cyclophosphamide (EC) and Nanoparticle Albumin Bound (Nab) Paclitaxel for Newly Diagnosed Breast Cancer

Pathological complete response defined as breast only, ypT0/ ypTis regardless of nodal status

Safety will be measured using NCI Common Toxicity Criteria for Adverse Effects version 4.0

All patients receive APN201 and placebo at the same time. The irradiated region is divided vertically into two symmetric areas (left and right). One area is treated with APN201, the other area is treated with placebo (empty liposomes formulated as a hydrophilic gel) in a double-blind fashion.

APN201 (recombinant human superoxide dismutase (rhSOD) encapsulated in liposomal vesicles formulated as a hydrophilic gel)

Radiation Induced Dermatitis

All patients receive APN201 and placebo at the same time. The irradiated region is divided vertically into two symmetric areas (left and right). One area is treated with APN201 (recombinant human superoxide dismutase (rhSOD) encapsulated in liposomal vesicles formulated as a hydrophilic gel; 1.6 mg rhSOD per mL), the other area is treated with placebo (empty liposomes formulated as a hydrophilic gel) in a double-blind fashion.
Study treatment (APN201 and placebo) starts on the day of initiation of radiation therapy and continues until the end of radiation therapy to the whole breast (25 or 28 daily fractions to a total dose of 50.0 Gy or 50.4 Gy, respectively). Study treatment is applied as a thin film on the irradiated area ≥10 minutes each day before radiation therapy (approximately 1 mL APN201 per 100 cm2 of the radiation field size and approximately 1 ml placebo per 100 cm2 of the radiation field size).

APN201

Placebo

Medical University Graz; Department of Therapeutic Radiology and Oncology

Study of APN201 (Liposomal Recombinant Human Cu/Zn-Superoxide Dismutase) for the Prevention of Radiation-induced Dermatitis in Women With Breast Cancer

Randomized, Double-blind, Split-body, Placebo-controlled Phase Ib Study of APN201 (Liposomal Recombinant Human Cu/Zn-superoxide Dismutase) for the Prevention of Radiation-induced Dermatitis in Women With Breast Cancer

Adverse events, vital signs and laboratory assessments (hematology, serum chemistry) are used for safety evaluations.

The following parameters are used for efficacy evaluations:
Time to ≥ grade 2 radiation dermatitis
Incidence of ≥ grade 2 radiation dermatitis
Severity of radiation dermatitis
Pain intensity (pain on touching the skin) due to radiation therapy
Irradiated skin evaluations using the digital wound documentation system W.H.A.T. (wound healing analysing tool) and a spectrophotometer

Apeiron Biologics

SOD1 inhibitor ATN-224

exemestane

protein expression analysis

proteomic profiling

laboratory biomarker analysis

pharmacological study

Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford

Exemestane With or Without ATN-224 in Treating Postmenopausal Women With Recurrent or Advanced Breast Cancer

A Cancer Research UK Randomised Phase II Trial of ATN-224 (Copper Binding Agent) in Combination With Exemestane Versus Exemestane Alone in Post-menopausal Women With Recurrent or Advanced, Oestrogen and/or Progesterone Receptor Positive Breast Cancer

superoxide dismutase/breast neoplasms

Effects of Training and Detraining on Postmenopausal Breast Cancer Survivors

Effect of a Clinical Nutrition Intervention Program in Breast Cancer Patients During Antineoplastic Treatment

IST Neoadjuvant Abraxane in Newly Diagnosed Breast Cancer

Study of APN201 (Liposomal Recombinant Human Cu/Zn-Superoxide Dismutase) for the Prevention of Radiation-induced Dermatitis in Women With Breast Cancer

Exemestane With or Without ATN-224 in Treating Postmenopausal Women With Recurrent or Advanced Breast Cancer

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