Overcome, a Program of Therapeutic Exercise and Functional Recovery to Improve the Functional Capacity of Women With Breast Cancer and Bone Metastases

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.

Study Overview

• Status: Recruiting
• Conditions: Neoplasm Metastasis; Breast Neoplasm Female; Spinal Neoplasms
• Intervention / Treatment: Other: Overcome

• Study Type: Interventional
• Enrollment (Estimated): 58
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mario Lozano-Lozano, Dr; Phone Number: +34958249590; Email: mlozano@ugr.es
• Study Contact Backup: Name: Mario Lozano-Lozano; Phone Number: +34958249590; Email: mlozano@ugr.es

Study Locations

• Spain
  • Granada, Spain, 18016
    • Recruiting
    • Faculty of Health Sciences
    • Sub-Investigator: Noelia Galiano-Castillo, Phd
    • Contact: Mario Lozano-Lozano, PhD; Phone Number: +34958249590; Email: mlozano@ugr.es
    • Principal Investigator: Manuel Arroyo-Morales, PhD
    • Sub-Investigator: Lydia Martin-Martin, PhD
    • Sub-Investigator: Carolina Fernandez-Lao, PhD
    • Sub-Investigator: Irene Cantarero-Villanueva, PhD
    • Principal Investigator: Mario Lozano-Lozano, PhD
    • Sub-Investigator: María Fernández-González, MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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
2. The bone metastasis is located only at bone level (low neurological risk).
3. Not having exercised regular physical during last 3 months.
4. ECOG (Eastern Cooperative Oncology Group) ≤ 1.
5. > 4 weeks from a major surgery and full recovery.

Exclusion Criteria:

1. 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
2. Present any other toxicity greater than grade 2 in related to the treatments you are receiving or received in advance.
3. Have spinal cord involvement, epidural involvement or instrumentation due to disease metastatic. (Moderate-high neurological risk)
4. Have started or changed treatment hormonal during the last 3 months at recruitment.
5. Present any pathology that prevents participation in a physical exercise program (PARQ-YOU).
6. Present brain metastasis.
7. Present uncontrolled hypertension (during recruitment, ≥2 / 3 evaluations <160/90 regardless of whether a regimen of antihypertensive therapy or not).
8. 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).
9. Present a psychiatric illness, which would prevent the patient from signing the informed consent or adhere to the study protocol.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Overcome group; 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.	Other: Overcome; 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.
No Intervention: Usual treatment; Usual medical treatment for the same period of time

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional capacity	6-minute walking test	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.	Participants will be followed over 14 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
hand strength	Hand dynamometry, for which a digital dynamometer (TKK) 5101 Grip-D; Takey, Tokyo, Japan)	Participants will be followed over 14 weeks
Lower limb strength	sit-up text	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)	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.	Participants will be followed over 14 weeks
Pain threshold on pressure, by algometry	Electronic algometer (Somedic AB, Farsta, Sweden)	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.	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.	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.	Participants will be followed over 14 weeks

Collaborators and Investigators

• Sponsor: Universidad de Granada

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2022
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: December 28, 2021
• First Submitted That Met QC Criteria: February 15, 2022
• First Posted (Actual): February 17, 2022

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Neoplasms by Site; Breast Diseases; Musculoskeletal Diseases; Neoplastic Processes; Spinal Diseases; Bone Diseases; Bone Neoplasms; Neoplasms; Breast Neoplasms; Neoplasm Metastasis; Spinal Neoplasms
• Other Study ID Numbers: Overcome project

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No