A clinical trial incorporates data on the lifestyle of breast cancer patients to assess their bone health

The study led by Incliva collects information through smart devices to better direct treatment

VALENCIA, May 3. (EUROPA PRESS) -

The Incliva Health Research Institute has launched a clinical trial on bone health in breast cancer patients, within the framework of the European 'Rebecca' project. The objective is to incorporate data on the way of life of these women to assess their condition and be able to improve treatment.

Incliva is leading this trial, in which the doctors Begoña Bermejo, Juan Miguel Cejalvo, Maite Martínez, Marta Tapia and Cristina Hernando, from the Research Group of the Breast Cancer Biology Group; and doctors Ana Martínez Aspas and Dolores Estellés, from the Gynecology and Obstetrics Service of the Clinical Hospital of Valencia.

Rebecca (Research on Breast Cancer induced chronic conditions supported by Causal Analysis of multi-source data), funded by the European Union's Horizon 2020 research and innovation programme, focuses on research into chronic diseases induced by breast cancer through based on real data obtained from multiple sources.

This project is based on a technological tool that allows obtaining information on the way of life of each patient -physical activity, diet, quality of sleep and the time spent daily at work, rest and travel- through smart devices - -as a mobile phone, tablet and smart watch- to integrate it into your clinical history and, in this way, be able to better direct your treatment, details the research institute in a statement.

The development of Rebecca is expected to demonstrate the usefulness of this tool, which could be applied to the care of patients with other types of cancer.

To achieve this goal, several clinical studies have been designed. One of them, called Rebecca-OST, led by Incliva, which was launched in January and has a duration of twelve months, focuses on research on bone health and osteoporosis induced by breast cancer treatment. .

It is an exploratory study that will evaluate the characteristics of the functional and emotional environment of the patients during the first year of treatment with adjuvant endocrine therapy with aromatase inhibitors, an oral hormonal treatment that is applied after localized treatment of the disease to reduce and prevent the risk of relapse and indicated from 5 to 10 years, one of whose side effects is its negative impact on bone health, since it accelerates the process of osteopenia and osteoporosis.

Osteopenia and osteoporosis are part of the same process of loss of bone mass and density, with osteopenia representing a lesser degree of deterioration in bone health than osteoporosis.

Osteopenia develops when there is low bone density and the bones are weaker than normal. In osteoporosis there is a decrease in the resistance of the bone against trauma or the load that favors fractures.

Breast cancer patients are at increased risk of osteoporosis-related fractures compared to healthy women of the same age, since most treatments, by causing a loss of estrogen, significantly decrease mineral density levels. Bone (BMD).

To counteract the important vital effects of BMD in patients with breast cancer, current disease management schemes propose the integration of non-pharmacological measures to maintain optimal bone health, such as weight-bearing exercise and calcium and vitamin D8 supplementation.

However, they point out, the lack of objective data on the effects of increased BMD on lifestyle poses a serious challenge for the design of pragmatic and individualized patient management strategies.

In fact, lifestyle advice to increase physical activity is often generic and lacks disease-specific knowledge, which likely affects the efficacy of exercise interventions.

In general, more evidence is needed to optimize specific treatments for bone health, the use and choice of pharmacological agents, the duration of treatment, and the potential for interaction with ongoing endocrine treatments.

All this must be considered in parallel with the particularities of the lifestyle after treatment, the age of the patients and the interaction of ovarian suppression with the other comorbid chronic symptoms related to cancer.

In this scenario, Rebecca contributes real world data (RWD, for its acronym in English: Real World Data) that will allow the first objective exploratory evaluation of the functional and emotional characteristics of life in patients with breast cancer undergoing the first year of adjuvant endocrine therapy with aromatase inhibitors.

Rebecca-OST will include 82 patients --of which 43 have already been recruited-- divided into two groups, based on their BMD: one group with osteoporosis or severe osteopenia, and the other with moderate-mild osteopenia or normal BMD.

In addition to the BMD baseline exam, all participants in both groups receive a smartwatch, which they will use continuously throughout the twelve-month trial, as well as training in its use.

Through the Rebecca platform, the data will be collected from the devices provided (smart watch and application for mobile and tablet), in addition to that obtained during the visits and periodic examinations, with the aim of comparing both groups in terms of items of quality of life and functional-emotional indices.