Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05244382
Other study ID # Overcome project
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 7, 2022
Est. completion date June 2025

Study information

Verified date November 2023
Source Universidad de Granada
Contact Mario Lozano-Lozano, Dr
Phone +34958249590
Email mlozano@ugr.es
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 58
Est. completion date June 2025
Est. primary completion date June 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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 Design


Intervention

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.

Locations

Country Name City State
Spain Faculty of Health Sciences Granada

Sponsors (1)

Lead Sponsor Collaborator
Universidad de Granada

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Functional capacity 6-minute walking test Participants will be followed over 14 weeks
Primary 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 hand strength Hand dynamometry, for which a digital dynamometer (TKK) 5101 Grip-D; Takey, Tokyo, Japan) Participants will be followed over 14 weeks
Secondary Lower limb strength sit-up text Participants will be followed over 14 weeks
Secondary 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
Secondary 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
Secondary Pain threshold on pressure, by algometry Electronic algometer (Somedic AB, Farsta, Sweden) Participants will be followed over 14 weeks
Secondary 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
Secondary 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
Secondary 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
See also
  Status Clinical Trial Phase
Withdrawn NCT06057636 - Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study N/A
Terminated NCT03166631 - A Trial to Find the Safe Dose for BI 891065 Alone and in Combination With BI 754091 in Patients With Incurable Tumours or Tumours That Have Spread Phase 1
Terminated NCT01441115 - ECI301 and Radiation for Advanced or Metastatic Cancer Phase 1
Active, not recruiting NCT03775980 - CIRSE Emprint Microwave Ablation Registry
Completed NCT01114958 - Pilot Study of Intra-Arterial Cisplatin With IV Thiosulfate in Patients With Lung Cancer or Lung Metastases Phase 1
Terminated NCT03986593 - Cryoablation of Bone Metastases From Endocrine Tumors N/A
Active, not recruiting NCT04458259 - Study of PF-07265807 in Participants With Metastatic Solid Tumors. Phase 1
Completed NCT01218542 - Whole Brain Radiation Therapy With Boost to Metastatic Tumor Volume Using RapidArc N/A
Not yet recruiting NCT03175146 - A Study to See Whether Stereotactic Body RadioTherapy (SBRT) Can Shrink Tumours Within the Liver Safely N/A
Active, not recruiting NCT02395224 - A Longitudinal Study of Colorectal Cancer Patients With Metastatic Disease in Middle-Norway
Completed NCT02374411 - Knowledge, Attitudes, and Practice of Surgeons Toward Nutrition Support in HIPEC Patients N/A
Recruiting NCT01960829 - Everolimus in Selected Patients With Metastatic Melanoma: Efficacy and Safety Study Phase 2
Terminated NCT01846429 - Oral Bicarbonate as Adjuvant for Pain Reduction in Patients With Tumor Related Pain Phase 1
Completed NCT01933789 - Improving Communication About Serious Illness N/A
Recruiting NCT01564810 - Cetuximab in Combination With Chemotherapy for the Treatment of Metastatic Colorectal Cancer Phase 4
Completed NCT00375245 - Rapamycin With Grapefruit Juice for Advanced Malignancies Phase 1
Completed NCT00207116 - An Exploratory Pharmacogenomic Study of Monotherapy Erbitux in Subjects With Metastatic Non Small Cell Lung Carcinoma Phase 1
Completed NCT00232726 - Clinical Study of Previously Untreated Patients With Malignant Melanoma Phase 2
Completed NCT00207103 - MAD in Cancer Patients: Safety of BMS-582664 in Patients With Advanced or Metastatic Solid Tumors Phase 1
Completed NCT00172003 - Effect of Zoledronic Acid in Patients With Renal Cell Cancer and Bone Metastasis Phase 4