Symptoms and General Pathology

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Inflammation

Breast Neoplasms

Breast Diseases

Skin Diseases

Menopause

All Drugs and Chemicals

Hormones

Jenny Chang-Claude, Prof. Dr.

The MARIEplus study is a prospective cohort of breast cancer patients recruited into the MARIE (Mamma Carcinoma Risk factor InvEstigation) study, a population-based case-control study of breast cancer conducted in two German study regions, Hansestadt Hamburg and Rhine-Neckar-Karlsruhe (RNK) region. Participants were identified through participating clinics and the Hamburg cancer registry between January 1st, 2001 and September 30th, 2005 in Hamburg and between August 1st, 2002 and July 31st, 2005 in the RNK study region. Patients were aged 50-74 years at histologically confirmed primary invasive (stages I to IV) or in situ breast tumor (stage 0). Comprehensive information on demographic, socio-economic, and lifestyle factors was collected at multiple time points: at recruitment by a standardized face-to-face interview and at follow-up median 6 years as well as 11 years later using computer assisted telephone interview.

Vital status was assessed in 2009 and again in 2015 via the population registries and causes of death were obtained from death certificates and coded according to the 10th revision of the International Statistical Classification of Diseases and Related Health Problems (ICD-10).

Information on the clinical course was abstracted from medical records to verify clinical events either self-reported in follow-up interviews or reported by treating physicians.

The studies were approved by the ethics committee of the University of Heidelberg and the University of Hamburg and conducted in agreement with the Helsinki Declaration. Written informed consent was provided by all participants at baseline and during follow-up.

The primary objectives of this study are

* To assess the association of modifiable lifestyle factors and personal factors, including BMI, diet, physical activity, tobacco and alcohol use, menopausal hormone therapy, socioeconomic status, with breast cancer survival, overall and according to tumor type, after accounting for established prognostic factors.
* To examine the influence of genetic variants on breast cancer relapse and survival
* To assess the association of lifestyle factors and their changes in the course of survivorship on subsequent breast cancer prognosis.
* To assess the individual and combined association of inflammation/metabolic biomarkers as well as changes in their serum levels with subsequent breast cancer prognosis overall and according to tumor type.
* To assess whether and to what extent the associations between breast cancer prognosis and lifestyle factors and/or their changes are mediated by circulating biomarker levels.

Nonfasting serum or plasma samples provided at recruitment and follow-up by the patients are stored at -80°C.

Influence of Lifestyle, Inflammatory Biomarkers, and Genetic Factors on Long-term Breast Cancer Prognosis

The Influence of Lifestyle and Genetic Risk Factors, Circulating Inflammatory Biomarkers and Menopausal Hormone Therapy on Long-term Prognosis After Postmenopausal Breast Cancer

Risk of mortality (all-cause, breast cancer specific)

German Cancer Research Center

From the first postoperative day, with the approval of the surgeon performing the operation, the postoperative exercise program will be started once a day under the supervision of a physiotherapist during the stay of the participants in the hospital.

At the same time, participants will be directed to moderate intensity aerobic exercise (walking, jogging...) for 150 min/week. Information will be given on the importance of physical activity and increasing the level of physical activity. In addition, a brochure containing explanatory information about the postoperative physiotherapy program after breast surgery will be given to the participants.

The patients in the control group will be informed about the postoperative physiotherapy program and patient education will be provided by the physiotherapist before the operation. Within the knowledge and approval of the surgeon performing the operation, preoperatively, respiratory control, diaphragmatic breathing, relaxation exercises, passive-active assistive-active range of motion exercises are shown by the physiotherapist, and patient education is provided with information about possible postoperative complications and what needs to be considered. will be given.

only preoperative patient information is given.

preoperative patient informaiton, information leaflet and Physiotherapy meeting will be held every 2 weeks for 3 months

physitherapy follow-up

no intervention; preoperative patient informaiton and information leaflet

control

Sevda YILMAZ, dr

Hande ŞENOL, dr

At least 42 patients between the ages of 30-65, who were followed up in Pamukkale University General Surgery Breast Polyclinic and planned for breast surgery, will be included in the study. Those who met the criteria for inclusion in the study and those who voluntarily agreed to participate in the study, who were preoperatively evaluated, will be randomly divided into two groups using the closed envelope method by matching age, gender, type of surgery and breast cancer stage. The first of these groups is the study (n=21) and the second is the control group (n=21).

Study group: Patients in the study group will be informed about the postoperative physiotherapy program and patient education will be provided by the physiotherapist before the operation. After obtaining the consent of the surgeon performing the operation, preoperative and post-operative complications (infection, lymphedema, fatigue...) and the things to be considered (use of upper extremities, skin care, importance of weight control...) and patient education will be given by the physiotherapist. In addition, respiratory control, diaphragmatic breathing, relaxation exercises, gradual passive-active assistive-active range of motion exercises, stretching exercises will also be demonstrated preoperatively.

From the first postoperative day, with the approval of the surgeon performing the operation, the postoperative exercise program will be started once a day under the supervision of a physiotherapist during the stay of the participants in the hospital.

At the same time, participants will be directed to moderate intensity aerobic exercise (walking, jogging...) for 150 min/week. Information will be given on the importance of physical activity and increasing the level of physical activity. In addition, a brochure containing explanatory information about the postoperative physiotherapy program after breast surgery will be given to the participants.

Participants will continue the exercises as a home program after discharge. During this follow-up period, the participants will meet again with the physiotherapist every two weeks for the control, compliance and continuity of the exercises. In these interviews, while compliance with the exercise program is checked, exercise tolerance will also be determined and necessary interventions and modifications will be made. In case of any complication (limitation in physical functions, lymphedema...) during the home program, he will be informed about meeting with the relevant physician and physiotherapist as soon as possible.

Control group: The patients in the control group will be informed about the postoperative physiotherapy program and patient education will be provided by the physiotherapist before the operation. Within the knowledge and approval of the surgeon performing the operation, preoperatively, respiratory control, diaphragmatic breathing, relaxation exercises, passive-active assistive-active range of motion exercises are shown by the physiotherapist, and patient education is provided with information about possible postoperative complications and what needs to be considered. will be given.

Written consent of all participants was obtained; demographic information will be recorded, and their physical and psychosocial conditions will be evaluated. Circumference measurements for lymphedema The extremity volume will be calculated using the Frustum formula. Modified Constant Murley Score for shoulder and upper extremity loss of function and evaluation of activities of daily living, pectoralis major and pectoralis minor shortness tests, Tanita for body composition determination, L-Dex score for bioimpedance analysis, Functional Evaluation of Breast Cancer Treatment for functional status ( Functional Assessment of Cancer Therapy -Breast Cancer - FACT-B scale, Cancer Fatigue Scale for fatigue, 6 Minute Walk Test (6MWT) for cardiovascular endurance and Hospital Anxiety and Depression Scale (HAD) for psychosocial status will be used. All measurements will be repeated preoperatively (at least 3 days before the operation), on the 1st postoperative day and 3 months later.

intervention (Group 1), control (Group 2) and routine follow-up (Group 3) groups

participants do not know which group they belong to

The Effect of Early Rehabilitation After Breast Cancer Surgery on Physical and Psychosocial Functions

The circumference measurements for lymphedema will be calculated using the Frustum formula. calculations will compare with operated and non-operated limb, and also subsequent measurements. A volume increase of \>200 ml is interpreted as the onset of lymphedema.

Modified Constant Murley Score for assessment of shoulder and upper extremity functions. high score indicates good function.

Pectoralis major and pectoralis minor muscle shortness tests.measurements will compare with operated and non-operated limb, and also subsequent.

Tanita bioimpedance analysis device will be used to determine body composition. Measurements will be compared with the subsequent. bioimpedance analysis determines that; body weight (kg), muscle mass (kg), estimated bone ratio (kg).

Tanita bioimpedance analysis device will be used to determine body composition. Measurements will be compared with the subsequent. bioimpedance analysis determines that; body mass index (kg/m2).

Tanita bioimpedance analysis device will be used to determine body composition. Measurements will be compared with the subsequent. bioimpedance analysis determines that; body fat percentage, body water percentage.

Tanita bioimpedance analysis device will be used to determine body composition. Measurements will be compared with the subsequent. bioimpedance analysis determines that; visceral fat level.

Tanita bioimpedance analysis device will be used to determine body composition. Measurements will be compared with the subsequent. bioimpedance analysis determines that; total daily energy consumption (kcal/day).

Tanita bioimpedance analysis device will be used to determine body composition. Measurements will be compared with the subsequent. bioimpedance analysis determines that; metabolic age (years).

Moisturemeter compactD for measurement of subdermal fluid ratio. Measurements will be compared with the subsequent.

Cancer Fatigue Scale for assesment of fatigue. A low score indicates a low fatigue rate.

6 Minute Walk Test (6MWT) will be used for cardiovascular endurance.Changes of \>35 m are significant changes.

It is expected that the psychosocial functions that have decreased due to breast cancer will be restored in a short time with physiotherapy follow-up and improvement of physical functions. Hospital Anxiety and Depression Scale (HAD) will be used for psychosocial status. A low score indicates low anxiety and depression.

Functional Assessment of Cancer Therapy -Breast Cancer (FACT-B) scale for assessment of functional status and activities of daily living. high score indicates good function.

Pamukkale University

Principal Investigator; Phd. PT

Recurrence

Disease Progression

Phytoestrogens

Miriam V Dwek, PhD

Diet has been found to influence hormone production and metabolism which in turn could affect the incidence of hormone related cancers. Consumption of soy-containing foods, known to be rich in phytoestrogens, is thought to be one of the chemoprotective factors against breast cancer in Asian populations. Phytoestrogens have a wide range of metabolic effects and may have a role in effecting breast cancer risk. Although there is mounting evidence of the positive influence of phytoestrogens on breast cancer risk, very little research has been carried out in humans as to the effects of phytoestrogens on breast cancer recurrence and survival. The DietCompLyf study aims to explore this effect by carrying out an observational study in 3,000 breast cancer women in the UK. The effects of diet, lifestyle practices and use of complementary treatments will also be investigated. Participants are recruited 9-15 months post-diagnosis and followed up for 5 years. Questionnaires as well as blood and urine samples are collected annually.

Women matching the eligibility criteria are consented at breast cancer follow-up hospital visits. Blood and urine samples are then collected and questionnaires are provided for the participants to take away and return within 4 weeks. The process of sample collection and questionnaire provision is repeated for visit at years 3 and 5.

Year 2 and 4 study visit vary in that questionnaires including a 7 day food diary are sent to participants at home to be filled in 7 days before their scheduled follow-up appointment. At hospital, blood and urine samples are collected as usual.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Influence of Lifestyle, Inflammatory Biomarkers, and Genetic Factors on Long-term Breast Cancer Prognosis	NCT03401034	Breast Cancer Breast Cancer M... Breast Cancer S... Postmenopausal ... Lifestyle Genetic Factors Inflammation Inflammatory Bi... Hormone Therapy Phytoestrogens		50 Years - 74 Years	German Cancer Research Center
The Effect of Early Rehabilitation After Breast Cancer Surgery on Physical and Psychosocial Functions	NCT04979715	Breast Cancer S...	physitherapy fo... control	30 Years - 65 Years	Pamukkale University
The Role of Diet and Lifestyle in Breast Cancer Survival	NCT00701584	Breast Cancer		18 Years - 75 Years	University College London Hospitals

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