Breast Neoplasm FemaleNCT04479098
Effects of Training and Detraining on Postmenopausal Breast Cancer Survivors
A study testing Resistance exercise training and Exercise detraining in people with Breast Neoplasm Female, run by Federal University of Uberlandia at 1 site in Brazil.
Trial summary
The present study aimed to verify the effects of resistance exercise training and successive detraining on body composition, lipid profile, muscle strength, oxidative stress, and inflammatory markers of postmenopausal breast cancer survivors undergoing tamoxifen treatment. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women only
- Conditions the study is for
- Breast Neoplasm Female
- What is being tested?
- Resistance exercise training and Exercise detraining
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jul 2016to 30 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1) age between 40 and 65 years; 2) stage 0-IIIA Breast Cancer; 3) submission to axillary lymphadenectomy); 4) completion of chemotherapy and radiation therapy at least 6 months before the study; 5) lack of participation in supervised physical exercise programs in the six months before the beginning of the research; 6) absence of a problem and/or musculoskeletal limitation that would prevent the performance of the proposed exercises; 7) release by a medical professional to participate in the physical training program; 8) residency in Uberlândia
Who cannot join
- missing more than 20% of the exercise sessions; unable to perform the proposed training protocols; change in drug therapy during the intervention.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Training and Detraining on Body Composition and Inflammatory, Oxidative and Lipid Profiles of Postmenopausal Breast Cancer Survivors Undergoing Tamoxifen Treatment
The present study aimed to verify the effects of resistance exercise training and successive detraining on body composition, lipid profile, muscle strength, oxidative stress, and inflammatory markers of postmenopausal breast cancer survivors undergoing tamoxifen treatment.
Read the detailed description
The present study aimed to verify the effects of 12 weeks of resistance exercise training and successive 12 weeks of detraining on body composition (Body Mass, Body Mass Index, Fat Mass, and Fat-Free Mass), lipid profile (Triglycerides, Total Cholesterol, LDL-Cholesterol, HDL-Cholesterol), muscle strength (1RM test), oxidative stress (Thiobarbituric acid reactive substances,Non-Protein Thiols, Catalase activity, and Superoxide Dismutase), and inflammatory markers (Interferon γ, Tumor Necrosis Factor α, interleukin 6 , Adiponectin, and Interleukin 4) of postmenopausal breast cancer survivors undergoing tamoxifen treatment.
- Conditions
- Breast Neoplasm Female
- Being tested
- Resistance exercise training, Exercise detraining
- Keywords
- Breast Cancer, Immune function, Inflammation, Resistance exercise, Oxidative Stress, Menopause
- Medical subject headings
- Breast Neoplasms, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance exercise trainingOther
The exercise training program will last 12 weeks, with a frequency of three sessions per week, held on Mondays, Wednesdays, and Fridays. Each session will last approximately 50 minutes. Whenever the maximum number of pre-established repetitions is successfully performed, the intensity will be increased by 5 to 10%. All sessions will be supervised by trained professionals.
Exercise detrainingOther
The exercise detraining will last 12 weeks without exercise.
| Study group | Role | What they receive |
|---|---|---|
| Exercise training | Experimental | Postmenopausal breast cancer survivors undergoing tamoxifen treatment, who will do the evaluations before the beginning and after 12 weeks of exercise training and subsequently 12 weeks of detraining. Receives: Other: Resistance exercise training; Other: Exercise detraining |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in blood biomarkers (pg/mL)
Blood samples will be collected after 8-10 hours overnight fasting directly in evacuated tubes containing separator gel. After centrifugation for 10 min at 3000 rpm, the serum will be separated for immediate analysis or stored at -80 °C for further analysis. Serum levels of IL-4, IL-6, IFN-γ, TNF-α and Adiponectin will be determined by enzyme-linked immunosorbent assays (ELISA) using commercial kits (BD Biosciences, San Jose, CA, USA), according to the manufacturer's instructions, in an Immulite 2000 analyzer (BD Biosciences, San Jose, CA, USA). Expressed in pg/mL.
Measured: Before and within 72 hours after 12 weeks of exercise training/detraining
Changes in blood biomarkers (mmol/L)
Blood samples will be collected after 8-10 hours overnight fasting in evacuated tubes containing separator gel. After 10 min centrifugation at 3000 rpm, the serum will be stored at -80 °C for further analysis. Lipid peroxidation was estimated by determining the serum concentration of thiobarbituric acid reactive substances (TBARS). The TBARS concentration will be obtained by spectrophotometric reading at 535 nm and interpolation in a malondialdehyde calibration curve. Oxidative damage to serum proteins will be estimated by determining the concentration of carbonylated proteins by reading the absorbance at 370 nm and using the molar absorptivity coefficient of 22.000 M-1cm-1. The levels of non-protein thiols will be obtained by the colorimetric method based on the reaction of the sulfhydryl group with 5,5'-dithiobis (2-nitrobenzoic acid) (DTNB). Expressed in mmol/L.
Measured: Before and within 72 hours after 12 weeks of exercise training/detraining
Changes in blood biomarkers (K/gHb.s)
Blood samples will be collected after 8-10 hours overnight fasting directly in evacuated tubes containing separator gel. After centrifugation for 10 min at 3000 rpm, the serum will be separated for immediate analysis or stored at -80 °C for further analysis.Catalase (Cat) activity was evaluated by the ability of this enzyme to convert H2O2 into O2 and H2O. Expressed in K/gHb.s.
Measured: Before and within 72 hours after 12 weeks of exercise training/detraining
Changes in blood biomarkers (U/gHb)
Blood samples will be collected after 8-10 hours overnight fasting directly in evacuated tubes containing separator gel. After centrifugation for 10 min at 3000 rpm, the serum will be separated for immediate analysis or stored at -80 °C for further analysis. The activity of superoxide dismutase (SOD) was evaluated based on their ability to inhibit pyrogallol auto-oxidation and promote a decline in absorbance at 420 nm over time. Expressed in U/gHb.
Measured: Before and within 72 hours after 12 weeks of exercise training/detraining
Changes in blood biomarkers (mg/dL)
Blood samples will be collected after 8-10 hours overnight fasting directly in evacuated tubes containing separator gel. After centrifugation for 10 min at 3000 rpm, the serum will be separated for immediate analysis or stored at -80 °C for further analysis. The serum levels of triglycerides (TGC), total cholesterol (t-C), high-density lipoprotein cholesterol (HDL-C) and low-density lipoprotein cholesterol (LDL-C) will be determined using commercial kits (Labtest, Lagoa Santa, MG, Brazil) in a Technicon RA-XT biochemical analyzer (Bayer, New York, NY, USA). Expressed in mg/dL.
Measured: Before and within 72 hours after 12 weeks of exercise training/detraining
Secondary outcomes (4)
Strength (kg)
The test of one-repetition maximum (1-RM) was adopted to assess muscle strength in all exercises, except for abdominal exercise on the ground, which will be performed only with body mass. Before each test, the subjects will perform a general warm-up (3-5 minutes of light activity), followed by dynamic stretches also for the muscles involved. Then, the participants will perform a specific set of warm-ups that consisted of 8 repetitions with approximately 50% of the estimated load for 1-RM, followed by 3 repetitions with 70% of the estimated load for 1-RM. Subsequently, the loads will be progressively increased until the 1-RM load was found. Rest intervals of approximately 4 to 5 minutes will be inserted between each attempt and the result will be considered valid when performed properly, in a controlled manner, and without assistance from the researchers involved in the assessment. The number of attempts to determine such values will be not more than five. Expressed in kg.
Measured: Before and within 72 hours after 12 weeks of exercise training/detraining
Anthropometry (kg)
Fat mass (FM) and lean mass (LM) will be measured using a tetrapolar bioimpedance analyzer (InBody230™, Seoul, Korea). Expressed in kg.
Measured: Before and within 72 hours after 12 weeks of exercise training/detraining
Anthropometry (%)
Fat mass percentage (BF%) will be measured using a tetrapolar bioimpedance analyzer (InBody230™, Seoul, Korea).
Measured: Before and within 72 hours after 12 weeks of exercise training/detraining
Anthropometry (kg/m²)
Height was measured in a stadiometer with 0.1 cm accuracy and total body mass was measured using a balance with 0.1 kg accuracy. Body mass index will be calculated using the formula: body mass/height². Expressed in kg/m².
Measured: Before and within 72 hours after 12 weeks of exercise training/detraining
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2020
- Study start1 Jul 2016
- Primary completion31 Jul 2017
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Neoplasm FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Uberlandia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Igor Moraes Mariano, Federal University of Uberlandia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04479098
- Sponsor's protocol ID
- CEP 57837416.5.0000.5152/2016
- Status last verified
- Jul 2020
- First submitted
- 16 Jul 2020
- Last updated
- 21 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Training and Detraining on Body Composition and Inflammatory, Oxidative and Lipid Profiles of Postmenopausal Breast Cancer Survivors Undergoing Tamoxifen Treatment
- ClinicalTrials.gov ID
- NCT04479098
- Acronym / sponsor ID
- CEP 57837416.5.0000.5152/2016
- Conditions
- Breast Neoplasm Female
- Keywords
- Breast Cancer, Immune function, Inflammation, Resistance exercise, Oxidative Stress, Menopause
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Federal University of UberlandiaUniversity, hospital or other
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 31 Jul 2017 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 21 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present study aimed to verify the effects of resistance exercise training and successive detraining on body composition, lipid profile, muscle strength, oxidative stress, and inflammatory markers of postmenopausal breast cancer survivors undergoing tamoxifen treatment.
Detailed description
The present study aimed to verify the effects of 12 weeks of resistance exercise training and successive 12 weeks of detraining on body composition (Body Mass, Body Mass Index, Fat Mass, and Fat-Free Mass), lipid profile (Triglycerides, Total Cholesterol, LDL-Cholesterol, HDL-Cholesterol), muscle strength (1RM test), oxidative stress (Thiobarbituric acid reactive substances,Non-Protein Thiols, Catalase activity, and Superoxide Dismutase), and inflammatory markers (Interferon γ, Tumor Necrosis Factor α, interleukin 6 , Adiponectin, and Interleukin 4) of postmenopausal breast cancer survivors undergoing tamoxifen treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise training | Experimental | Other: Resistance exercise training, Other: Exercise detrainingPostmenopausal breast cancer survivors undergoing tamoxifen treatment, who will do the evaluations before the beginning and after 12 weeks of exercise training and subsequently 12 weeks of detraining. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1) age between 40 and 65 years; 2) stage 0-IIIA Breast Cancer; 3) submission to axillary lymphadenectomy); 4) completion of chemotherapy and radiation therapy at least 6 months before the study; 5) lack of participation in supervised physical exercise programs in the six months before the beginning of the research; 6) absence of a problem and/or musculoskeletal limitation that would prevent the performance of the proposed exercises; 7) release by a medical professional to participate in the physical training program; 8) residency in Uberlândia
Key exclusion criteria (1 listed)
- missing more than 20% of the exercise sessions; unable to perform the proposed training protocols; change in drug therapy during the intervention.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resistance exercise trainingThe exercise training program will last 12 weeks, with a frequency of three sessions per week, held on Mondays, Wednesdays, and Fridays. Each session will last approximately 50 minutes. Whenever the maximum number of pre-established repetitions is successfully performed, the intensity will be increased by 5 to 10%. All sessions will be supervised by trained professionals. | Other | Exercise training |
| Exercise detrainingThe exercise detraining will last 12 weeks without exercise. | Other | Exercise training |
Primary outcome
Changes in blood biomarkers (pg/mL)
Time frame: Before and within 72 hours after 12 weeks of exercise training/detraining
Blood samples will be collected after 8-10 hours overnight fasting directly in evacuated tubes containing separator gel. After centrifugation for 10 min at 3000 rpm, the serum will be separated for immediate analysis or stored at -80 °C for further analysis. Serum levels of IL-4, IL-6, IFN-γ, TNF-α and Adiponectin will be determined by enzyme-linked immunosorbent assays (ELISA) using commercial kits (BD Biosciences, San Jose, CA, USA), according to the manufacturer's instructions, in an Immulite 2000 analyzer (BD Biosciences, San Jose, CA, USA). Expressed in pg/mL.
Changes in blood biomarkers (mmol/L)
Time frame: Before and within 72 hours after 12 weeks of exercise training/detraining
Blood samples will be collected after 8-10 hours overnight fasting in evacuated tubes containing separator gel. After 10 min centrifugation at 3000 rpm, the serum will be stored at -80 °C for further analysis. Lipid peroxidation was estimated by determining the serum concentration of thiobarbituric acid reactive substances (TBARS). The TBARS concentration will be obtained by spectrophotometric reading at 535 nm and interpolation in a malondialdehyde calibration curve. Oxidative damage to serum proteins will be estimated by determining the concentration of carbonylated proteins by reading the absorbance at 370 nm and using the molar absorptivity coefficient of 22.000 M-1cm-1. The levels of non-protein thiols will be obtained by the colorimetric method based on the reaction of the sulfhydryl group with 5,5'-dithiobis (2-nitrobenzoic acid) (DTNB). Expressed in mmol/L.
Changes in blood biomarkers (K/gHb.s)
Time frame: Before and within 72 hours after 12 weeks of exercise training/detraining
Blood samples will be collected after 8-10 hours overnight fasting directly in evacuated tubes containing separator gel. After centrifugation for 10 min at 3000 rpm, the serum will be separated for immediate analysis or stored at -80 °C for further analysis.Catalase (Cat) activity was evaluated by the ability of this enzyme to convert H2O2 into O2 and H2O. Expressed in K/gHb.s.
Changes in blood biomarkers (U/gHb)
Time frame: Before and within 72 hours after 12 weeks of exercise training/detraining
Blood samples will be collected after 8-10 hours overnight fasting directly in evacuated tubes containing separator gel. After centrifugation for 10 min at 3000 rpm, the serum will be separated for immediate analysis or stored at -80 °C for further analysis. The activity of superoxide dismutase (SOD) was evaluated based on their ability to inhibit pyrogallol auto-oxidation and promote a decline in absorbance at 420 nm over time. Expressed in U/gHb.
Changes in blood biomarkers (mg/dL)
Time frame: Before and within 72 hours after 12 weeks of exercise training/detraining
Blood samples will be collected after 8-10 hours overnight fasting directly in evacuated tubes containing separator gel. After centrifugation for 10 min at 3000 rpm, the serum will be separated for immediate analysis or stored at -80 °C for further analysis. The serum levels of triglycerides (TGC), total cholesterol (t-C), high-density lipoprotein cholesterol (HDL-C) and low-density lipoprotein cholesterol (LDL-C) will be determined using commercial kits (Labtest, Lagoa Santa, MG, Brazil) in a Technicon RA-XT biochemical analyzer (Bayer, New York, NY, USA). Expressed in mg/dL.
4 secondary outcomes
Strength (kg)
Time frame: Before and within 72 hours after 12 weeks of exercise training/detraining
Anthropometry (kg)
Time frame: Before and within 72 hours after 12 weeks of exercise training/detraining
Anthropometry (%)
Time frame: Before and within 72 hours after 12 weeks of exercise training/detraining
Anthropometry (kg/m²)
Time frame: Before and within 72 hours after 12 weeks of exercise training/detraining
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance exercise training and Exercise detraining in people with Breast Neoplasm Female, run by Federal University of Uberlandia at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in blood biomarkers (pg/mL) (time frame: Before and within 72 hours after 12 weeks of exercise training/detraining). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2020.