Breast Neoplasm FemaleNCT05244382
Overcome, a Program of Therapeutic Exercise and Functional Recovery to Improve the Functional Capacity of Women With Breast Cancer and Bone Metastases
A study testing Overcome in people with Breast Neoplasm Female and Neoplasm Metastasis, run by Universidad de Granada at 1 site in Spain.
Trial summary
The research to be carried out is aimed at patients with metastatic breast cancer, specifically bone metastases. These patients will be recruited from two hospitals in Granada, provided they meet the established inclusion criteria. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasm Female, Neoplasm Metastasis, Spinal Neoplasms
- What is being tested?
- Overcome
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteSpain
- Study dates
- 7 Feb 2022to Jun 2025
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having breast cancer controlled primary and occurrence of one or more bone lesions (metastases osteoblastic) with location in the pelvis, lumbar spine and / or thoracic, attributable to breast cancer
- The bone metastasis is located only at bone level (low neurological risk).
- Not having exercised regular physical during last 3 months.
- ECOG (Eastern Cooperative Oncology Group) ≤ 1.
- > 4 weeks from a major surgery and full recovery.
Who cannot join
- Present cardiac toxicity secondary to treatments with decreased LVEF (If the LVEF percentage falls ≥ 10 points with respect to baseline or LVEF is below 50%) or QT prolongation
- Present any other toxicity greater than grade 2 in related to the treatments you are receiving or received in advance.
- Have spinal cord involvement, epidural involvement or instrumentation due to disease metastatic. (Moderate-high neurological risk)
- Have started or changed treatment hormonal during the last 3 months at recruitment.
- Present any pathology that prevents participation in a physical exercise program (PARQ-YOU).
- Present brain metastasis.
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- Present uncontrolled hypertension (during recruitment, ≥2 / 3 evaluations <160/90 regardless of whether a regimen of antihypertensive therapy or not).
- Having had a serious cardiovascular event recently (in the last 12 months), including, but not limited to ischemic attack transient (TIA), cerebrovascular accident (CVA) or myocardial infarction (MI).
- Present a psychiatric illness, which would prevent the patient from signing the informed consent or adhere to the study protocol.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Faculty of Health Sciences
Granada, 18016
Mario Lozano-Lozano, PhD, +34958249590, mlozano@ugr.es
Manuel Arroyo-Morales, PhD
About this study
Official title: OveRCoME: functiOnal Recovery Cancer MEtastasis
The research to be carried out is aimed at patients with metastatic breast cancer, specifically bone metastases. These patients will be recruited from two hospitals in Granada, provided they meet the established inclusion criteria. With this study, it is pretend to demonstrate the benefits of a program of therapeutic exercise and functional recovery of motor control with ultrasound feedback for the improvement of the functional capacity of the women eligible to participate in the study, as well as a positive impact on the quality of life of the patients other than their survival. The effect of the Overcome program will be compared with the usual treatment in this type of pathology. To do this, a pre-intervention evaluation and another at the end of the evaluation of the variables to be measured, such as functional capacity, will be carried out. In addition other evaluation will be carried out, after 6 months to assess the long-term effects.
In addition to the three main variables such as functional capacity and quality of life, another relationship of secondary variables will be studied, such as physical state, body composition or pain threshold, among others. This study in its entirety will be carried out by the "Oncology Patient Support Unit - Take Care" in the hands of a multidisciplinary team, carrying out the intervention protocolized by physiotherapists and occupational therapists.
- Being tested
- Overcome
- Medical subject headings
- Neoplasm Metastasis, Spinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OvercomeOther
Multimodal program individualized and supervised 12 weeks duration (three months), with two sessions weekly face-to-face. This program will combine aerobic exercise in unloading through the use of the TRAG (AlterG® Anti-Gravity Treadmill®), functional recovery of motor control with feedback ultrasound and occupational therapy. Physical activity will be measured in parallel with the test. Likewise, the patients will be monitored by means of a heart rate sensor.
| Study group | Role | What they receive |
|---|---|---|
| Overcome group | Experimental | Three-month multimodal program. Aerobic exercise will be combined with the use of TRAG (AlterG® Anti-Gravity Treadmill®), functional recovery of motor control with feedback ultrasound and occupational therapy. Receives: Other: Overcome |
| Usual treatment | No intervention | Usual medical treatment for the same period of time |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional capacity
6-minute walking test
Measured: Participants will be followed over 14 weeks
Quality of life (QLQ)
QLQ-C30 (Quality of Life of Cancer Patients) by the "European organization for reseach and treatment of cáncer quality life" (EORTC). This scale has 30 items, divided into a global health scale, 5 function subscales and 9 items/symptom scales. The scoring is obtained from through an Excel template.
Measured: Participants will be followed over 14 weeks
Secondary outcomes (8)
hand strength
Hand dynamometry, for which a digital dynamometer (TKK) 5101 Grip-D; Takey, Tokyo, Japan)
Measured: Participants will be followed over 14 weeks
Lower limb strength
sit-up text
Measured: Participants will be followed over 14 weeks
Body composition
Height will be measured (cm). Weight (kg), body mass index, skeletal muscle mass, and body fat percentage will be obtained using bioelectrical impedance analysis (InBody 720; Biospace, Seoul, South Korea)
Measured: Participants will be followed over 14 weeks
Muscle architecture of multifidus muscle
Muscle ultrasound and quantitative elastosonography will be performed of the multifidus muscle. We will obtain information in real time on the parameters related to the structural organization of the tissues (normal or abnormal elasticity) with respect to the adjacent tissue.
of the multifidus muscle.
Measured: Participants will be followed over 14 weeks
Pain threshold on pressure, by algometry
Electronic algometer (Somedic AB, Farsta, Sweden)
Measured: Participants will be followed over 14 weeks
Anxiety and depression
"Hospital Anxiety and Depression Scale" (HADS). Composed of two subscales: Depression and Anxiety, each with seven items. The score of each subscale can vary between 0 and 21, since each item presents four response options, ranging from absence/minimal presence = 0, to maximum presence = 3.
Measured: Participants will be followed over 14 weeks
Opioid consumption and pain
By the scale"Brief Pain Inventory-SF". This questionnaire consists of 15 items of which only two subscales are scored organized into mean pain intensity (items 3-6) and mean pain interference (items 9A-9G), the rest of the items do not score.
Measured: Participants will be followed over 14 weeks
Specific quality of life of the patient with bone metastasis
QLQ-BM22 (quality of life questionnaire for bone metastases) by the "European organization for reseach and treatment of cáncer quality life" (EORTC). This questionnaire consists of 22 questions, which represent eight sections on symptom scales: five identify the painful sites, and three describe the characteristics of the pain; 14 headings represent functional scales: eight, of functional interferences, and six, refer to psychosocial aspects.
Measured: Participants will be followed over 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2022
- Study start7 Feb 2022
- Primary completionJun 2024 (estimated)
- Study completionJun 2025 (estimated)
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mario Lozano-Lozano, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05244382
- Sponsor's protocol ID
- Overcome project
- Status last verified
- Nov 2023
- First submitted
- 28 Dec 2021
- Last updated
- 29 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OveRCoME: functiOnal Recovery Cancer MEtastasis
- ClinicalTrials.gov ID
- NCT05244382
- Acronym / sponsor ID
- Overcome project
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- 7 Feb 2022 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 17 Feb 2022 (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 research to be carried out is aimed at patients with metastatic breast cancer, specifically bone metastases. These patients will be recruited from two hospitals in Granada, provided they meet the established inclusion criteria. With this study, it is pretend to demonstrate the benefits of a program of therapeutic exercise and functional recovery of motor control with ultrasound feedback for the improvement of the functional capacity of the women eligible to participate in the study, as well as a positive impact on the quality of life of the patients other than their survival. The effect of the Overcome program will be compared with the usual treatment in this type of pathology. To do this, a pre-intervention evaluation and another at the end of the evaluation of the variables to be measured, such as functional capacity, will be carried out. In addition other evaluation will be carried out, after 6 months to assess the long-term effects.
In addition to the three main variables such as functional capacity and quality of life, another relationship of secondary variables will be studied, such as physical state, body composition or pain threshold, among others. This study in its entirety will be carried out by the "Oncology Patient Support Unit - Take Care" in the hands of a multidisciplinary team, carrying out the intervention protocolized by physiotherapists and occupational therapists.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Overcome group | Experimental | Other: OvercomeThree-month multimodal program. Aerobic exercise will be combined with the use of TRAG (AlterG® Anti-Gravity Treadmill®), functional recovery of motor control with feedback ultrasound and occupational therapy. |
| Usual treatment | No intervention | –Usual medical treatment for the same period of time |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Having breast cancer controlled primary and occurrence of one or more bone lesions (metastases osteoblastic) with location in the pelvis, lumbar spine and / or thoracic, attributable to breast cancer
- The bone metastasis is located only at bone level (low neurological risk).
- Not having exercised regular physical during last 3 months.
- ECOG (Eastern Cooperative Oncology Group) ≤ 1.
- > 4 weeks from a major surgery and full recovery.
Key exclusion criteria (9 listed)
- Present cardiac toxicity secondary to treatments with decreased LVEF (If the LVEF percentage falls ≥ 10 points with respect to baseline or LVEF is below 50%) or QT prolongation
- Present any other toxicity greater than grade 2 in related to the treatments you are receiving or received in advance.
- Have spinal cord involvement, epidural involvement or instrumentation due to disease metastatic. (Moderate-high neurological risk)
- Have started or changed treatment hormonal during the last 3 months at recruitment.
- Present any pathology that prevents participation in a physical exercise program (PARQ-YOU).
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 |
|---|---|---|
| OvercomeMultimodal program individualized and supervised 12 weeks duration (three months), with two sessions weekly face-to-face. This program will combine aerobic exercise in unloading through the use of the TRAG (AlterG® Anti-Gravity Treadmill®), functional recovery of motor control with feedback ultrasound and occupational therapy. Physical activity will be measured in parallel with the test. Likewise, the patients will be monitored by means of a heart rate sensor. | Other | Overcome group |
Primary outcome
Functional capacity
Time frame: Participants will be followed over 14 weeks
6-minute walking test
Quality of life (QLQ)
Time frame: Participants will be followed over 14 weeks
QLQ-C30 (Quality of Life of Cancer Patients) by the "European organization for reseach and treatment of cáncer quality life" (EORTC). This scale has 30 items, divided into a global health scale, 5 function subscales and 9 items/symptom scales. The scoring is obtained from through an Excel template.
8 secondary outcomes
hand strength
Time frame: Participants will be followed over 14 weeks
Lower limb strength
Time frame: Participants will be followed over 14 weeks
Body composition
Time frame: Participants will be followed over 14 weeks
Muscle architecture of multifidus muscle
Time frame: Participants will be followed over 14 weeks
Pain threshold on pressure, by algometry
Time frame: Participants will be followed over 14 weeks
Anxiety and depression
Time frame: Participants will be followed over 14 weeks
Opioid consumption and pain
Time frame: Participants will be followed over 14 weeks
Specific quality of life of the patient with bone metastasis
Time frame: Participants will be followed over 14 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Overcome in people with Breast Neoplasm Female and Neoplasm Metastasis, run by Universidad de Granada at 1 site in Spain.
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 5 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 29 Nov 2023. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mario Lozano-Lozano, Dr (+34958249590, mlozano@ugr.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional capacity (time frame: Participants will be followed over 14 weeks). The study lists 2 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 29 Nov 2023.