Breast neoplasms Neoplasms
Conditions
Interventions
This is a randomized, placebo-controlled, double-blind, crossover clinical trial. The study will include 108 women with breast cancer undergoing neoadjuvant or adjuvant chemotherapy, randomized into t
Sponsors
Instituto do Câncer do Ceará
Instituto do Câncer do Ceará
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Women; aged 18 years or older; diagnosis of stage II, III, or IV breast cancer; prescribed neoadjuvant chemotherapy; treatment with chemotherapy regimens containing anthracyclines (doxorubicin or epirubicin), alkylating agents (cyclophosphamide), or taxanes (paclitaxel or docetaxel); treatment with AC (doxorubicin + cyclophosphamide), AC-T (doxorubicin + cyclophosphamide followed by paclitaxel or docetaxel), or DC (docetaxel + cyclophosphamide) regimens.
Exclusion criteria
Exclusion criteria: History of tumor recurrence; renal insufficiency; hepatic insufficiency; breast cancer as a second primary malignancy; no access to WhatsApp; cognitive impairment; withdrawal from the study; progression to palliative care; need for surgery before the time scheduled in the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected that a reduction in the severity of sarcopenia will be observed in women with breast cancer undergoing neoadjuvant chemotherapy after supervised remote physical training, with or without creatine supplementation, verified by means of bioelectrical impedance and handgrip dynamometry. Skeletal muscle mass, skeletal muscle mass index, and handgrip strength values ??obtained before the start of the intervention and after the completion of the protocol will be compared, as well as between the study groups.;It is expected that a reduction in the severity of fatigue will be observed in women with breast cancer undergoing neoadjuvant chemotherapy after supervised remote physical training, with or without creatine supplementation, as verified by the Brazilian version of the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale. Fatigue scores obtained before the start of the intervention and after the completion of the protocol will be compared, as well as between the study groups, considering the variation in FACIT-F scale scores throughout the follow-up period. | — |
Secondary
| Measure | Time frame |
|---|---|
| The aim is to characterize the clinical, nutritional, and body composition conditions of the participants before the start of neoadjuvant chemotherapy, through the collection of clinical data, bioelectrical impedance analysis, and laboratory tests. The frequency values, means, standard deviations, and proportions of the evaluated variables will be described.;It is expected to determine the frequency of sarcopenia and fatigue before the start of neoadjuvant chemotherapy, using the results of electrical bioimpedance, manual dynamometry and the FACIT-F scale. The percentages of participants classified as having sarcopenia and fatigue in the initial assessment will be presented.;Higher adherence to supervised remote physical training during chemotherapy is expected, as verified by the record of sessions completed via the MFIT PERSONAL® app. The percentage of sessions completed per participant throughout the intervention period will be calculated. | — |
Countries
BR
Contacts
Public ContactPaulo Goberlânio Silva
Instituto do Câncer do Ceará
Outcome results
None listed