An interventional study of Aerobic Training Presential and Aerobic Training Home-based in Cancer of Breast and Healthy, sponsored by Universidade Estadual Paulista Júlio de Mesquita Filho. Completed at 1 site in Brazil. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-04-30.
Sponsored by Universidade Estadual Paulista Júlio de Mesquita Filho · Not applicable, Interventional, and Treatment
Among 350 studies in Breast Neoplasms with a site in Brazil — 52 open to participants now, 111 under way, 61 of them phase 3. Breast Neoplasms · Brazil.
Among the 350 studies in Breast Neoplasms with a site in Brazil, this one is the 303rd largest by enrollment of the 308 interventional ones that give a count, is one of 15 that started in 2018, is one of 78 with no phase, and was the 179th registered.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
Browse Breast Neoplasms studies →52 of the 350 studies in Breast Neoplasms with a site in Brazil are open now. Recruiting first, the newest first:
BeOne Medicines · Sites in Brazil, United States, Australia and 13 more countries
Hoffmann-La Roche · Sites in Brazil, United States, Argentina and 23 more countries
Hoffmann-La Roche · Sites in Brazil, United States, Argentina and 9 more countries
Eli Lilly and Company · Sites in Brazil, United States, Argentina and 16 more countries
Hospital de Clinicas de Porto Alegre · Sites in Brazil
A study can be open while its sites in Brazil have not opened yet or have stopped. Only those recruiting at a site in Brazil →
Of the 2,400 Breast Neoplasms studies recruiting now, 1,572 (66%) set no upper age limit and 591 (25%) stop at 75 or younger; 103 take children under 18; 214 take healthy volunteers.
This study: 18 Years and older · female · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
350 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 14 · Phase 2 79 · Phase 3 149 · Phase 4 4
First in 1997; this study’s year is marked. 15 started in 2018.
This study's enrollment of 6 is below the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Median enrollment 250 across the 308 interventional studies, 251 across the 40 observational. Of the 205 that completed or were terminated, 109 (53%) have results posted.
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214 of 350 have an industry lead sponsor. The 10 most frequent:
Universidade Estadual Paulista Júlio de Mesquita Filho is the lead sponsor of 82 studies on the registry; 9 are open to participants now.
Universidade Estadual Paulista Júlio de Mesquita Filho has 2 studies filed under Breast Neoplasms — fewer than ten, so there is no comparison to draw.
32 of the studies in Breast Neoplasms with a site in Brazil that are under way reach primary completion within a year, 17 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05646862Phase 3Hoffmann-La RocheA Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy | 2026-11-13 |
| NCT05909397Phase 3PfizerVepdegestrant (ARV-471/PF-07850327) + Palbociclib vs Letrozole + Palbociclib in ER(+)/HER2(-) Advanced Breast Cancer | 2026-12-30 |
| NCT05894239Phase 3Hoffmann-La RocheA Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer | 2026-12-31 |
| NCT04906395Phase 3Tolmar Inc.Ovarian Suppression Evaluating Subcutaneous Leuprolide Acetate in Breast Cancer | 2027-01-30 |
| NCT06839001Phase 3Hospital do CoracaoCRYoablation for Small Tumors As Local Treatment - SIX Trial | 2027-03-01 |
Among the 350 studies in Breast Neoplasms with a site in Brazil, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Introduction. Treatment with hormone therapy reduced the likelihood of tumor recurrence and metastasis in the patient. However, it has adverse effects such as: loss of bone mineral density, increase in body weight, metabolic changes and, consequently, lower quality of life. Physical training has been used as a means of reducing these and other adverse effects, but there is no definite protocol on which training model is effective, especially in patients who only use Tamoxifen or Aromatase Inhibitor as an adjuvant therapy for treatment of breast cancer.
Objective: To compare the effect of aerobic training on body composition, metabolic and inflammatory variables, physical activity level, sleep, anxiety, depression, body image, fatigue, strength, flexibility and quality of life of women undergoing breast cancer treatment use Tamoxifen and Aromatase Inhibitor and women without cancer.
Method. The sample will be formed by women without cancer and under treatment with hormone therapy being accompanied by the public service for treatment of breast cancer of the city of Presidente Prudente. A 24-week notification in which the face-to-face training group will undergo aerobic training three times a week on interspersed days and the group accompanied at a distance will perform as a preferred activity under a distance supervision of professionals every 14 days of return to attend the UNESP for the adequacy of the analysis and selection of attendance to the proposed activities. Evaluations of the variables of interest at the baseline of the intervention will be performed after 12 weeks and soon after the intervention. The investigators will analyze: biomarkers (TNFα, LDL, HDL, VLDL, as well as in the lipid profile (triglycerides, total cholesterol and LDL fractions ), glycemia, insulin, anthropometric measurements, physical activity level, sleep, pain, anxiety, depression, body image, fatigue, strength, flexibility. Trainings will be performed within the target zone of maximum heart rate. Comparisons between groups at each time point will be performed using Student's T-test for independent samples. The comparisons of the variables of interest at the initial moment and after 12 and 24 weeks will be made through the multivariate analysis, where the group effects, time and interaction of both will be compared. All analyzes will be performed in SPSS software version 24.0 and significance of 5%.
Introduction. Breast cancer is one of the leading causes of morbidity and mortality in the world.Treatment with hormone therapy reduced the likelihood of tumor recurrence and metastasis in the patient. However, it has adverse effects such as: loss of bone mineral density, increase in body weight, metabolic changes (lipid and low grade systemic inflammation) and, consequently, lower quality of life. Physical training has been used as a means of reducing these and other adverse effects, but there is no definite protocol on which training model is effective, especially in patients who only use Tamoxifen or Aromatase Inhibitor as an adjuvant therapy for treatment of breast cancer.
Objective: To compare the effect of aerobic training on body composition, metabolic and inflammatory variables, physical activity level, sleep, anxiety, depression, body image, fatigue, strength, flexibility and quality of life of women undergoing breast cancer treatment use Tamoxifen and Aromatase Inhibitor and women without cancer.
Method. The sample will be formed by women without cancer and under treatment with hormone therapy being accompanied by the public service for treatment of breast cancer of the city of Presidente Prudente. Where participants will be distributed in six groups submitted to intervention with aerobic training: Tamoxifen group with face-to-face training (GTP); Aromatase Inhibitor Group with face-to-face training (GIP); Tamoxifen training group by distance monitoring (GTA); Training group Aromatase inhibitor by distance monitoring (GIA); Group without training with cancer (GC) and Group training face-to-face without cancer (GTSC). A 24-week notification in which the face-to-face training group will undergo aerobic training three times a week on interspersed days and the group accompanied at a distance will perform as a preferred activity under a distance supervision of professionals every 14 days of return to attend the UNESP for the adequacy of the analysis and selection of attendance to the proposed activities. Evaluations of the variables of interest at the baseline of the intervention will be performed after 12 weeks and soon after the intervention. The investigators will analyze: biomarkers will analyze: biomarkers (Tumor Necrosis Factor-Alpha (TNFα), (LDL), High Density Lipoprotein (HDL), and Very Low Density Lipoprotein (VLDL), as well as in the lipid profile (triglycerides, total cholesterol and low density lipoprotein (LDL) fractions) ), glycemia, insulin, anthropometric measurements, physical activity level, sleep, pain, anxiety, depression, body image, fatigue, strength, flexibility. Trainings will be performed within the target zone of maximum heart rate. Comparisons between groups at each time point will be performed using Student's T-test for independent samples. The comparisons of the variables of interest at the initial moment and after 12 and 24 weeks will be made through the multivariate analysis, where the group effects, time and interaction of both will be compared. All analyzes will be performed in SPSS software version 24.0 and significance of 5%.
Inclusion Criteria:
Inclusion Criteria for the group without cancer
Exclusion Criteria:
A group of women with breast cancer who use Tamoxifen or Aromatase Inhibitor and will perform presential aerobic training.
Other: Aerobic Training Presential
A group of women without breast cancer who use Aromatase Inhibitor and will perform presential aerobic training.
Other: Aerobic Training Presential
A group of women with breast cancer who use Tamoxifen or Aromatase Inhibitor and will perform home-based aerobic training.
Other: Aerobic Training Home-based
A group of women without breast cancer who use Aromatase Inhibitor and will perform aerobic training home-based.
Other: Aerobic Training Home-based
The intervention will last 24 weeks, in which the presential training group will undergo aerobic training three times a week on interspersed days, more follow-up.
Also known as: Physical exercise Presential
The intervention will last 24 weeks, the group accompanied by the distance will carry out the activities in their preferred place under the distance supervision of professionals and every 14 days must attend the UNESP to adjust the intensity and verification of attendance to the proposed activities, more follow-up.
Also known as: Physical exercise Home-based
Evaluation of body composition by Bone Densitometry (DEXA) equipment
Reduction of body mass and of increased fat free mass
Time frame: 24 week
Evaluation of quality of life by questionnarie EORTC-QLQ-30
Increased of quality of life global
Time frame: 24 week
Evaluation inflammatory response by ELISA equipment
Reduction of interleukin- IL 6
Time frame: 24 week
Evaluation of pain by questionnarie BPI.
Reduction of pain intensity to increased of functional capacity
Time frame: 24 week
Evaluation of level of physical activity by triaxial accelerometer equipment
Increased of level of physical activity
Time frame: 24 week
Nutritional evaluation by food register
Increased of quality of food
Time frame: 24 week
Plan to share: No
Ran from Jul 2018 to primary completion in Jun 2019, 11 months.
Of 2,661 non-industry interventional studies with no phase under Breast Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 66. This study's 11 months is below that.
Counting every sponsor, half of 2,771 studies reached it within 33 months; a quarter within 15 and three quarters within 66.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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Universidade Estadual Paulista Júlio de Mesquita Filho