TeleHealth Resistance Exercise Intervention to Preserve Dose Intensity and Vitality in Elder Breast Cancer Patients (THRIVE-65)
This research is being done to assess whether an exercise intervention with protein intake support vs a health education and support program will make it easier for women age 65 or older who are receiving chemotherapy for breast cancer to receive all of their planned chemotherapy according to schedule and at the planned dose.
NCT05535192 — Breast Cancer
Status: Recruiting
http://inclinicaltrials.com/breast-cancer/NCT05535192/
Use of a Tele-rehabilitation Platform to Enable Physical Activity in Women With Breast Cancer During the Quarantine Period Due to COVID-19.
Introduction: Cancer is the main public health problem in the world and is already among the main causes of death. Breast CA will be the second most common type of cancer in the Brazilian population between 2020-2022. The pandemic caused by COVID-19 brought several changes in society, affecting health services, one of which was the need to maintain regular treatment for various health conditions, such as cancer. Physical therapy is an essential part of the multidisciplinary treatment of cancer patients. With the new technologies available, it is possible to allow continuous treatment of cancer patients, even during quarantine, and one possibility is the application of information and communication technologies to provide rehabilitation therapy to remote people, called home telerehabilitation. Objective: To verify the effect of virtual reality (VR) training on motor performance, pain and heart rate variability variables in patients diagnosed with breast cancer. Methods: The study will be composed of 30 women over 18 years old with a diagnosis of breast cancer attended at an oncology physical therapy clinic in the city of Juiz de Fora - MG. Participants will undergo training using virtual reality technology, always guided by the researcher. There will be a total of 10 (ten) interventions, with two training sessions per week. The participant will be guided by a researcher who will instruct her online. Five games will be used: Reaction Time, Coincident Timing, Fitts, Genius, MoveHero. Participants will answer some questionnaires and scales such as EORTC QLQ-C30 which assesses quality of life in cancer patients, perceived exertion scale will be applied before and between matches, a mood scale (BRUMS) will be applied at the beginning and at the end of training and Affective Analog Face Scale for pain assessment and analysis of Heart Rate Variability (HRV) that will be performed before, during and after the first and last training, through a heart rate monitor that will be given to each participant and an application cell phone (Elite HRV).
NCT05530876 — Breast Cancer
Status: Active, not recruiting
http://inclinicaltrials.com/breast-cancer/NCT05530876/
Intervention to Promote Breast Cancer Screening Among American Indian Women
Our objectives in this project are to develop and evaluate the feasibility and effectiveness of the Mobile Web App Breast Cancer Screening (wMammogram) intervention that is culturally tailored for AI women residing in rural areas. The proposed study will be a multi-method, two-phase research project that will take place in South Dakota over a three-year period. The two phases are: (1) developing the wMammogram intervention and (2) evaluating the feasibility and efficacy of the wMammogram. Phase 1 incorporates a community-based participatory research approach and a series of focus groups with various stakeholders in American Indian (AI) communities to design a culturally informed and practically refined intervention. Phase 2 uses a randomized clinical trial (RCT) design with AI women. The wMammogram intervention will be applied throughout a seven-day period, with assessment at three intervals: baseline (face-to-face interview survey), one-week post-intervention (telephone survey), and six-month follow-up (telephone survey) and post-intervention focus group (qualitative assessment). The wMammogram intervention will be implemented with AI women using the two-arm RCT that includes recruiting a total of 120 AI women aged 40 to 70 years and randomly assigning them to either (a) the wMammogram intervention group (n=60) to receive culturally and personally tailored multilevel and multimedia messages through a Mobile Web App along with health navigator services or (b) the control group (n=60) to receive the mailing of printed educational materials on breast cancer and relevant screening guidelines along with health navigator services. Hypotheses: In assessing the efficacy and feasibility of the wMammogram, Investigators hypothesize that: (H1)The wMammogram intervention participants will show a higher rate of mammograms received than will participants in the educational materials intervention. (H2)The wMammogram intervention participants will show improvements in knowledge, attitude, and beliefs about breast cancer screening and readiness for mammography as compared to participants in the educational materials intervention. (H3)The wMammogram intervention participants will demonstrate greater satisfaction with and acceptance of the intervention than would participants in the educational materials intervention.
NCT05530603 — Breast Cancer
Status: Completed
http://inclinicaltrials.com/breast-cancer/NCT05530603/
Phase II Study of Genomically Guided Radiation Dose Personalization in the Management of Triple Negative Breast Cancer
The purpose of the study is to determine the feasibility of genomically guided radiation therapy (RT) in people with triple negative (HER2 negative, hormone receptor negative) breast cancer undergoing breast conservation therapy.
NCT05528133 — Triple Negative Breast Cancer
Status: Recruiting
http://inclinicaltrials.com/triple-negative-breast-cancer/NCT05528133/
Prospective, Multicenter, Single-arm Clinical Study of Chemotherapy Combined With Bevacizumab Neoadjuvant Therapy for Early or Locally Advanced HER2-negative Breast Cancer
This is an prospective, multicenter, single-arm clinical study.
NCT05525767 — Solid Tumor
Status: Recruiting
http://inclinicaltrials.com/solid-tumor/NCT05525767/
Predicting an Accurate Tamoxifen Dose: a Feasibility Study in Patients With Hormone Sensitive Breast Cancer
Adjuvant treatment with tamoxifen is the standard of care for women with estrogen receptor positive (ER+) breast cancer. Tamoxifen is converted to endoxifen, its active metabolite, via CYP2D6 enzymes. The literature states that an endoxifen concentration of at least 16 nmol/L is needed to produce a therapeutic effect (4). Therapeutic Drug Monitoring (TDM) has been proven to be a successful technique to reach the 16 nmol/L endoxifen threshold after 6 months. However, in general TDM can only be used when a drug is in steady-state, which for endoxifen is reached after 3 months for normal metabolizers. For poor- and intermediate metabolizers, the time until steady-state is presumably even longer. This could possibly result in undertreatment within the first 3 to 6 months of tamoxifen treatment. In this study, model-informed precision dosing (MIPD) will be used to counter this problem. The Pharmacokinetic-model, which is used for MIPD, includes CYP2D6 genotype, co-medication, age, body height, BMI and CYP2D6/CYP3A inhibitor use to predict a patient tailored dose. Using MIPD, our aim is to decrease the proportion of patients that are undertreated within the first three months of tamoxifen treatment.
NCT05525481 — ER+ Breast Cancer
Status: Recruiting
http://inclinicaltrials.com/er-breast-cancer/NCT05525481/
Phase II, Open-Labeled, Single-Armed Combination Treatment With Anastrozole, Fulvestrant and Abemaciclib for Hormone Receptor Positive, HER2(-) Metastatic Breast Cancer
This is a phase 2, open-label, singled-arm clinical trial determining efficacy of combination therapy with anastrozole, fulvestrant and abemaciclib in subjects with breast cancer. These are subjects who are newly diagnosed advanced or metastatic hormone receptor positive breast cancer or subjects who have progressed following treatment free interval of more than 12 months following adjuvant or neoadjuvant treatment.
NCT05524584 — Breast Cancer
Status: Recruiting
http://inclinicaltrials.com/breast-cancer/NCT05524584/
Effect of Vitamin D and Calcium Supplementation on Letrozole-induced Musculoskeletal Side Effects in Breast Cancer Egyptian Patients
This study aims at assessing the vitamin Dstatus in breast cancer patients who receive letrozole for more than two months and to evaluate effects of vitamin D3 and calcium supplementation on arthalgia caused by letrozole on these patients.
NCT05523609 — Breast Cancer
Status: Recruiting
http://inclinicaltrials.com/breast-cancer/NCT05523609/
Effects on Quality of Life of Adapted Physical Activity Supervised by CAMI for Breast Cancer Patients.
Every year in France, there are approximately 58,000 new cases of breast cancer, which is the leading cancer in women according to the National Cancer Institute. Among the various tools in the fight against cancer, it is now proven that physical activity improves the prognosis of cancers, particularly breast cancer. Indeed, APA (Adapted Physical Activity) reduces morbidity and mortality, the risk of recurrence and improves quality of life. It is one of the tools of the Ten-Year Cancer Control Strategy 2021-2030 of the anti-cancer plan. However, it seems to be insufficiently proposed and prescribed in France at present. CAMI (Cancer Arts Martiaux et Information) is a non-profit association comprising health professionals specifically trained to support cancer patients through APA. It works in collaboration with the Hospices Civils de Lyon and in particular the Gynecology Department of the CHU (University Hospital Center) of Croix Rousse. According to the World Health Organization (WHO), quality of life is "an individual's perception of his or her place in life, in the context of the culture and value system in which he or she lives, in relation to his or her goals, expectations, norms and concerns. It is a very broad concept influenced in a complex way by the subject's physical health, psychological state, level of independence, social relationships as well as their relationship to the essential elements of their environment." Quality of life is thus synonymous with well-being, perceived health and life satisfaction. The quality of a person's life is based both on the objective elements of his or her life (physical health, living environment and material and/or contextual conditions) and on his or her experience, which can be defined as the subjective quality of life. Thus, quality of life is considered to be a multidimensional concept that is structured around four dimensions, the first of which encompasses the physical state (autonomy, physical abilities), the second the somatic sensations that often translate into the expression of pain, the consequences of trauma related to the disease or treatment. With the increase in the incidence of breast cancer and the improvement in its prognosis, the number of breast cancer survivors has increased significantly. Quality of life has become an important outcome measure in clinical breast cancer surveys and survival studies, in addition to survival. The investigators' main objective is to study the effects of APA managed by CAMI in routine practice, on the quality of life of breast cancer patients. They also want to analyze how, by whom, and which patients are referred to CAMI to improve their care and describe the program offered by CAMI. The aim of this research is therefore to establish an axis of work and improvement for the Gynecology Department of the Croix Rousse Hospital in order to better identify the patients for whom APA would be most beneficial, to better refer them to CAMI and to study in real practice the effects of APA on these patients.
NCT05523063 — Breast Cancer
Status: Withdrawn
http://inclinicaltrials.com/breast-cancer/NCT05523063/
Water and Land-based Aerobic Training on Health-related Outcomes in Breast Cancer Survivors: a Randomized Clinical Trial
Background: Breast cancer is the type of cancer that mostly affects women in the world. Although physical and psychological side effects accompany cancer and the aggressiveness of the treatment, regular practice of physical exercise is considered a non-pharmacological tool to improve the quality of life of breast cancer survivors. The present study aims to evaluate the effects of aerobic training programs in aquatic and land environments plus a health education program, compared with a health education program alone, on cancer-related fatigue and other health-related outcomes in breast cancer survivors. Methods: The WaterMama trial is a randomized, single-blinded, three-arm, parallel, superiority trial. Forty-eight women, ≥18 years of age, who have completed primary treatment and been diagnosed with stage I-III breast cancer are recruited. Participants are randomly allocated on a 1:1:1 ratio to 12-week interventions of aerobic exercise training programs either on the aquatic or land environment two times per week plus health education, or an active-control group receiving health education intervention, once a week. Cancer-related fatigue (primary outcome), physical fitness (i.e., muscle strength of the knee extensors, muscle thickness and muscle quality of quadriceps, resting heart rate, maximum oxygen consumption, and performance in functional tests), mental health (i.e., depressive and anxiety symptoms), cognitive function, pain and quality of life are measured before and after 12 weeks of intervention. The analysis plan will use an intention-to-treat approach and protocol criteria. Discussion: The conceptual hypothesis is that both training programs plus health education positively affect cancer-related fatigue, physical fitness, mental health, cognitive function, pain, and quality of life compared to the health education group alone. Additionally, it is expected that the aquatic program plus health education to provide more significant effects on cancer-related fatigue and physical parameters due to its multi-component character, with a consequent greater positive impact on other investigated parameters in this group.
NCT05520515 — Breast Cancer
Status: Recruiting
http://inclinicaltrials.com/breast-cancer/NCT05520515/