Back to resultsOvercome, a Program of Therapeutic Exercise and Functional Recovery to Improve the Functional Capacity of Women With Breast Cancer and Bone Metastases
Primary Purpose
Breast Neoplasm Female, Neoplasm Metastasis, Spinal Neoplasms
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Overcome
Sponsored by
About this trial
This is an interventional treatment trial for Breast Neoplasm Female
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Sites / Locations
- Faculty of Health SciencesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Overcome group
Usual treatment
Arm Description
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.
Usual medical treatment for the same period of time
Outcomes
Primary Outcome Measures
Functional capacity
6-minute walking test
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.
Secondary Outcome Measures
hand strength
Hand dynamometry, for which a digital dynamometer (TKK) 5101 Grip-D; Takey, Tokyo, Japan)
Lower limb strength
sit-up text
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)
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.
Pain threshold on pressure, by algometry
Electronic algometer (Somedic AB, Farsta, Sweden)
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05244382
Brief Title
Overcome, a Program of Therapeutic Exercise and Functional Recovery to Improve the Functional Capacity of Women With Breast Cancer and Bone Metastases
Official Title
OveRCoME: functiOnal Recovery Cancer MEtastasis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 7, 2022 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Granada
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasm Female, Neoplasm Metastasis, Spinal Neoplasms
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
58 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Overcome group
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual treatment
Arm Type
No Intervention
Arm Description
Usual medical treatment for the same period of time
Intervention Type
Other
Intervention Name(s)
Overcome
Intervention Description
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.
Primary Outcome Measure Information:
Title
Functional capacity
Description
6-minute walking test
Time Frame
Participants will be followed over 14 weeks
Title
Quality of life (QLQ)
Description
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.
Time Frame
Participants will be followed over 14 weeks
Secondary Outcome Measure Information:
Title
hand strength
Description
Hand dynamometry, for which a digital dynamometer (TKK) 5101 Grip-D; Takey, Tokyo, Japan)
Time Frame
Participants will be followed over 14 weeks
Title
Lower limb strength
Description
sit-up text
Time Frame
Participants will be followed over 14 weeks
Title
Body composition
Description
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)
Time Frame
Participants will be followed over 14 weeks
Title
Muscle architecture of multifidus muscle
Description
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.
Time Frame
Participants will be followed over 14 weeks
Title
Pain threshold on pressure, by algometry
Description
Electronic algometer (Somedic AB, Farsta, Sweden)
Time Frame
Participants will be followed over 14 weeks
Title
Anxiety and depression
Description
"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.
Time Frame
Participants will be followed over 14 weeks
Title
Opioid consumption and pain
Description
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.
Time Frame
Participants will be followed over 14 weeks
Title
Specific quality of life of the patient with bone metastasis
Description
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.
Time Frame
Participants will be followed over 14 weeks
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mario Lozano-Lozano, Dr
Phone
+34958249590
Email
mlozano@ugr.es
First Name & Middle Initial & Last Name or Official Title & Degree
Mario Lozano-Lozano
Phone
+34958249590
Email
mlozano@ugr.es
Facility Information:
Facility Name
Faculty of Health Sciences
City
Granada
ZIP/Postal Code
18016
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mario Lozano-Lozano, PhD
Phone
+34958249590
Email
mlozano@ugr.es
First Name & Middle Initial & Last Name & Degree
Manuel Arroyo-Morales, PhD
First Name & Middle Initial & Last Name & Degree
Noelia Galiano-Castillo, PhD
First Name & Middle Initial & Last Name & Degree
Lydia Martin-Martin, PhD
First Name & Middle Initial & Last Name & Degree
Carolina Fernandez-Lao, PhD
First Name & Middle Initial & Last Name & Degree
Irene Cantarero-Villanueva, PhD
First Name & Middle Initial & Last Name & Degree
Mario Lozano-Lozano, PhD
First Name & Middle Initial & Last Name & Degree
María Fernández-González, MSc
12. IPD Sharing Statement
Learn more about this trial
Overcome, a Program of Therapeutic Exercise and Functional Recovery to Improve the Functional Capacity of Women With Breast Cancer and Bone Metastases
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