Breast Cancer Clinical Trial
Official title:
Investigation of the Factors of Hang-Grip Strength-related Upper Extremity Functionality After Breast Cancer Surgery
Verified date | November 2021 |
Source | Izmir Bakircay University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Breast cancer is the most frequent cancer type in women globally. In conjunction with the new developments, breast cancer survival has increased therefore the management of long-term complications has gained importance. Breast cancer survivors can face the loss of muscle strength, increased fatigue and diminished physical function associated with treatment-related long term effects and psychological affection and thereby reduced quality of life. Upper extremity lymphedema or breast cancer-related lymphedema (BCRL) is one of the most prominent long term complications which affects breast cancer survivors in many ways after breast cancer surgery. It has been reported that breast cancer survivors with BCRL have the lower muscle strength and more activity limitations when compared to the ones free of BCRL. In BCRL, affected extremity has been found to 36% more weaker when compared to the unaffected side. Fatigue is one of the most prominent symptoms when considering cancer-related symptoms in cancer survivors. It has been stated that increased fatigue is correlated with increased activity limitation and deterioration in physical function. The hand-grip test which is frequently used in the assessment of decreased muscle function has been stated as a reliable and repeatable test in breast cancer survivors. In addition, this test is frequently applicable to assess mortality, physical and functional capacity, symptoms after surgery and to designate an exercise program. There are studies that investigate upper extremity function associated with hang-grip strength in breast cancer survivors. Yet, there is a lack of the objective result or conclusion of the BCRL effect on upper extremity function which is assessed with hang-grip strength when compared without BCRL. Therefore, this study is planned to investigate of cumulative effects of factors such as lymphedema severity, age, fatigue, body mass index, muscle strength, physical activity level, pain level, exercise benefits/barriers scale score on hand-grip strength related upper extremity functionality in breast cancer survivors.
Status | Completed |
Enrollment | 111 |
Est. completion date | September 30, 2021 |
Est. primary completion date | September 26, 2021 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 25 Years to 65 Years |
Eligibility | Inclusion Criteria: - Being aged between 25 and 65 years old - Having the ability to read and write in the Turkish language - Having unilateral (right or left) breast cancer surgery history - Being a woman - Finished adjuvant therapies such as chemotherapy and radiotherapy prior to participation Exclusion Criteria: - Active infection - Active/recurrent malignity - Having orthopedic and/or neurological defect - Having an advanced postural deficiency - Having nerve injury (Ulnar, median, radial nerve) - Having a loss of sensory - Bilateral (both side) breast cancer surgery - Having mental and cognitive problems which can interfere to participate - Serious range of movement restriction in shoulder, elbow and/or wrist joints - Having Carpal Tunnel Syndrome - Having reflex denervation and abnormal neural findings |
Country | Name | City | State |
---|---|---|---|
Turkey | Izmir Çigli State Training Hospital | Izmir | Çigli |
Lead Sponsor | Collaborator |
---|---|
Izmir Bakircay University |
Turkey,
Armer JM. The problem of post-breast cancer lymphedema: impact and measurement issues. Cancer Invest. 2005;23(1):76-83. — View Citation
Cantarero-Villanueva I, Fernández-Lao C, Fernández-DE-Las-Peñas C, Díaz-Rodríguez L, Sanchez-Cantalejo E, Arroyo-Morales M. Associations among musculoskeletal impairments, depression, body image and fatigue in breast cancer survivors within the first year after treatment. Eur J Cancer Care (Engl). 2011 Sep;20(5):632-9. doi: 10.1111/j.1365-2354.2011.01245.x. Epub 2011 Mar 17. — View Citation
De Angelis R, Tavilla A, Verdecchia A, Scoppa S, Hachey M, Feuer EJ, Mariotto AB. Breast cancer survivors in the United States: geographic variability and time trends, 2005-2015. Cancer. 2009 May 1;115(9):1954-66. doi: 10.1002/cncr.24217. — View Citation
Dibai-Filho AV, de Jesus Guirro RR, Koga Ferreira VT, Kelly de Oliveira A, Maria de Almeida A, de Oliveira Guirro EC. Analysis of chronic myofascial pain in the upper trapezius muscle of breast cancer survivors and women with neck pain. J Bodyw Mov Ther. 2018 Apr;22(2):237-241. doi: 10.1016/j.jbmt.2017.04.012. Epub 2017 Apr 28. — View Citation
Fernández-Lao C, Cantarero-Villanueva I, Fernández-de-las-Peñas C, Del-Moral-Ávila R, Menjón-Beltrán S, Arroyo-Morales M. Widespread mechanical pain hypersensitivity as a sign of central sensitization after breast cancer surgery: comparison between mastectomy and lumpectomy. Pain Med. 2011 Jan;12(1):72-8. doi: 10.1111/j.1526-4637.2010.01027.x. Epub 2010 Dec 10. — View Citation
Fong DY, Ho JW, Hui BP, Lee AM, Macfarlane DJ, Leung SS, Cerin E, Chan WY, Leung IP, Lam SH, Taylor AJ, Cheng KK. Physical activity for cancer survivors: meta-analysis of randomised controlled trials. BMJ. 2012 Jan 30;344:e70. doi: 10.1136/bmj.e70. — View Citation
Galiano-Castillo N, Fernández-Lao C, Cantarero-Villanueva I, Fernández-de-Las-Peñas C, Menjón-Beltrán S, Arroyo-Morales M. Altered pattern of cervical muscle activation during performance of a functional upper limb task in breast cancer survivors. Am J Phys Med Rehabil. 2011 May;90(5):349-55. doi: 10.1097/PHM.0b013e318214e406. — View Citation
Garabeli Cavalli Kluthcovsky AC, Urbanetz AA, de Carvalho DS, Pereira Maluf EM, Schlickmann Sylvestre GC, Bonatto Hatschbach SB. Fatigue after treatment in breast cancer survivors: prevalence, determinants and impact on health-related quality of life. Support Care Cancer. 2012 Aug;20(8):1901-9. doi: 10.1007/s00520-011-1293-7. Epub 2011 Oct 13. — View Citation
Gomes PR, Freitas Junior IF, da Silva CB, Gomes IC, Rocha AP, Salgado AS, do Carmo EM. Short-term changes in handgrip strength, body composition, and lymphedema induced by breast cancer surgery. Rev Bras Ginecol Obstet. 2014 Jun;36(6):244-50. — View Citation
Lee D, Hwang JH, Chu I, Chang HJ, Shim YH, Kim JH. Analysis of factors related to arm weakness in patients with breast cancer-related lymphedema. Support Care Cancer. 2015 Aug;23(8):2297-304. doi: 10.1007/s00520-014-2584-6. Epub 2015 Jan 10. — View Citation
Nesvold IL, Reinertsen KV, Fosså SD, Dahl AA. The relation between arm/shoulder problems and quality of life in breast cancer survivors: a cross-sectional and longitudinal study. J Cancer Surviv. 2011 Mar;5(1):62-72. doi: 10.1007/s11764-010-0156-4. Epub 2010 Oct 23. — View Citation
Park SW, Lee I, Kim JI, Park H, Lee JD, Uhm KE, Hwang JH, Lee ES, Jung SY, Park YH, Lee JY. Factors associated with physical activity of breast cancer patients participating in exercise intervention. Support Care Cancer. 2019 May;27(5):1747-1754. doi: 10.1007/s00520-018-4427-3. Epub 2018 Aug 25. — View Citation
Perez CS, das Neves LMS, Vacari AL, de Cássia Registro Fonseca M, de Jesus Guirro RR, de Oliveira Guirro EC. Reduction in handgrip strength and electromyographic activity in women with breast cancer. J Back Musculoskelet Rehabil. 2018;31(3):447-452. doi: 10.3233/BMR-170848. — View Citation
Satariano WA, Ragland DR, DeLorenze GN. Limitations in upper-body strength associated with breast cancer: a comparison of black and white women. J Clin Epidemiol. 1996 May;49(5):535-44. — View Citation
Smoot B, Wong J, Cooper B, Wanek L, Topp K, Byl N, Dodd M. Upper extremity impairments in women with or without lymphedema following breast cancer treatment. J Cancer Surviv. 2010 Jun;4(2):167-78. doi: 10.1007/s11764-010-0118-x. Epub 2010 Apr 7. — View Citation
Vardar-Yagli N, Sener G, Saglam M, Calik-Kutukcu E, Arikan H, Inal-Ince D, Savci S, Altundag K, Kutluk T, Ozisik Y, Kaya EB. Associations among physical activity, comorbidity, functional capacity, peripheral muscle strength and depression in breast cancer survivors. Asian Pac J Cancer Prev. 2015;16(2):585-9. — View Citation
Wilmoth MC, Coleman EA, Smith SC, Davis C. Fatigue, weight gain, and altered sexuality in patients with breast cancer: exploration of a symptom cluster. Oncol Nurs Forum. 2004 Nov 16;31(6):1069-75. Review. — View Citation
Winters-Stone KM, Bennett JA, Nail L, Schwartz A. Strength, physical activity, and age predict fatigue in older breast cancer survivors. Oncol Nurs Forum. 2008 Sep;35(5):815-21. doi: 10.1188/08.ONF.815-821. — View Citation
* Note: There are 18 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Hand-Grip Strength | Handgrip strength will be assessed with LaFayette Professional Hand Dynamometer, Model 5030L1, LaFayette Instruments, NY, USA). The standard position which can be achieved by 90-degree elbow flexion, shoulder abducted, and hand mid-prone positioned; 90-degree shoulder abduction and 90-degree shoulder abduction positions will be used to assess hang-grip strength. Three measurements will be requested and the maximum value of them will be recorded. 1 minute resting period will be provided between the positions at which handgrip is assessed. | 15 minutes | |
Secondary | Tissue Dielectric Constant Measurement: | Sub-tissue fluid proportion will be evaluated via Moisture Meter D (Delfin Technologies, Kuopio, Finland) on both upper extremity (right and left) in predefined reference points on volar side (6 cm distal and 8 cm proximal points from cubital crease, 10 cm inferior side point from axilla and dorsal point of web space in the hand) by using four different probes which can assess 0.5 mm, 1.5 mm, 2.5 mm and 5.0 mm depth. Values taken by 2.5 mm depth probe will be used to calculate the ratio (affected side TDC value/Unaffected side TDC value) to stage lymphedema severity along with the International Society of Lymphology staging system. | 30 minutes | |
Secondary | Muscle strength | Participants' muscle strength of shoulder flexion, abduction, and elbow flexion will be assessed via Handheld digital dynamometer (Lafayette Manual Muscle Tester, Model 01165, LaFayette Instruments, NY, USA). Both upper extremities will be assessed three times and the average value will be recorded. 1 minute resting period will be provided between the positions at which muscle strength is assessed. | 10 minutes | |
Secondary | Pain Threshold Measurement | The sensitive pain threshold and normal pain threshold will be evaluated by a digital algometer (Wagner FDIX, Greenwich, USA) on reference points as follows: C5-C6 zygapophyseal joints' lateral points, upper trapezius (proximal, middle and distal lateral points, length measured by a tape from C7 Processus spinosus to acromion and this length will be divided equally into three parts for proximal, middle and distal lateral point), deltoid muscle (crista deltoidea), dorsum of the webspace. Measurements will te took both for right and left upper extremity. Units will be recorded as kgf. | 8 minutes | |
Secondary | International Physical Activity Questionnaire-Short Form (IPAQ-SF) | This scale was intended to be filled to assess participants' physical activity levels within the last seven days. Then, MET calculations will be done via a basic Excel Spreadsheet which is pre-defined MET values formulated inside. Scale data then obtained according to the participants' answers and recorded. | 3 minutes | |
Secondary | Fatigue Impact Scale | This scale has 9 items that can be answered as "Strongly Disagree" through "Strongly Agree" by numbered as 1 and 7, respectively. Then total points will be calculated and divided into 9 to achieve the Fatigue Impact Scale score. The higher points will be indicated more perceived fatigue, while lower points indicate less. | 3 minutes | |
Secondary | Disabilities of Arm, Shoulder and Hand Scale (DASH) | DASH has 30 items related to upper extremity function. Participants will be requested to grade some expressions related to the function within a 5-point Likert scale as follows: "No difficulty: 1, Mild Difficulty:2, Moderate Difficulty: 3, Severe Difficulty: 4 and Unable to perform: 5). The symptom score of the DASH will be calculated as dividing filled items total score to filled items' number and minus one from this data then multiplying with 25. The higher points indicate a deteriorated shoulder and hand function while lower points indicate a better upper extremity function. | 10 minutes | |
Secondary | Exercise Benefits/ Barriers Scale | Exercise Benefits/Barriers Scale has 43 items each can be graded within a four-point Likert type scale. Barrier items are reverse coded. 43 items are all related to exercise and exercise beliefs in both in the aspect of health and general. Strongly disagree, disagree, agree, strongly agree will be scored as 1,2,3,4 or vice versa whether the item should de reversely coded, respectively. Total scores ranged between 29 and 172. The barrier scale score is ranged between 14 and 56. The benefits scale is also ranged between 29 and 116. The higher the score of Barriers scale, the greater the perception of barriers to exercise. | 20 minutes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04681911 -
Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer
|
Phase 2 | |
Completed |
NCT04890327 -
Web-based Family History Tool
|
N/A | |
Terminated |
NCT04066790 -
Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer
|
Phase 2 | |
Completed |
NCT03591848 -
Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility
|
N/A | |
Recruiting |
NCT03954197 -
Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients
|
N/A | |
Terminated |
NCT02202746 -
A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer
|
Phase 2 | |
Active, not recruiting |
NCT01472094 -
The Hurria Older PatiEnts (HOPE) With Breast Cancer Study
|
||
Withdrawn |
NCT06057636 -
Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study
|
N/A | |
Completed |
NCT06049446 -
Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors
|
||
Recruiting |
NCT05560334 -
A Single-Arm, Open, Exploratory Clinical Study of Pemigatinib in the Treatment of HER2-negative Advanced Breast Cancer Patients With FGFR Alterations
|
Phase 2 | |
Active, not recruiting |
NCT05501769 -
ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer
|
Phase 1 | |
Recruiting |
NCT04631835 -
Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer
|
Phase 1 | |
Completed |
NCT04307407 -
Exercise in Breast Cancer Survivors
|
N/A | |
Recruiting |
NCT03544762 -
Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation
|
Phase 3 | |
Terminated |
NCT02482389 -
Study of Preoperative Boost Radiotherapy
|
N/A | |
Enrolling by invitation |
NCT00068003 -
Harvesting Cells for Experimental Cancer Treatments
|
||
Completed |
NCT00226967 -
Stress, Diurnal Cortisol, and Breast Cancer Survival
|
||
Recruiting |
NCT06006390 -
CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A | |
Recruiting |
NCT06019325 -
Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy
|
N/A |