Clinical trial NCT05216302: Prehabilitation for Breast Cancer Surgery
Official title: Prehabilitation Program Based on Health Education and Nordic Walking to Reduce Musculoskeletal Impairments in Women Undergoing Breast Cancer Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: breast cancer
prehabilitation
exercise therapy
Lead sponsor: Universitat Pompeu Fabra
Sponsor class: OTHER
Collaborators: name: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
First posted: 2022-01-31
Enrollment: 64
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Prehabilitation for women diagnosed with breast cancer is commonly not part of the clinical pathways as little time (usually a few days) is left between diagnosis and surgery. However, a great proportion of these patients will undergo neoadjuvant chemotherapy which provides a window opportunity to improve patients' physical status to withstand surgery and minimize post-operative musculoskeletal complications associated with surgery.

To this end, the aim of this study is to assess the efficacy of a prehabilitation program consisting of health education and a supervised nordic walking-based intervention in women diagnosed with breast cancer currently undergoing neoadjuvant chemotherapy to decrease post-operative musculoskeletal impairments and improve functionality of the affected arm.

The study is an open-label, single-blind randomised controlled trial conducted at one tertiary hospital. Women diagnosed with breast cancer scheduled for surgery and currently undergoing chemotherapy will be randomised to either usual care (UC) or prehabilitation (PREHAB). Patients will be assessed for eligibility during the fourth out of six course of chemotherapy. Those randomised to the PREHAB group will participate in a supervised group-based nordic walking intervention twice weekly during 8 weeks (approximately 16 sessions). In addition, participants will receive written information regarding the benefits of exercise during cancer treatment and surveillance. Patients will be assessed prior to surgery as well as at 1, 3 and 6 months postoperatively.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of breast cancer scheduled for surgery with or without lymphadenectomy
* Candidates to receive neoadjuvant chemotherapy
* Not currently undergoing any other physical therapy therapies or treatments

Exclusion Criteria:

* Cognitive impairment or inability to read Catalan or Spanish
* Prior diagnosis of shoulder impairment or injury
* Major musculoskeletal, neurological or cardiorespiratory limitations to prevent participation in the exercise program

Primary outcomes:
measure: Disabilities of the Arm Shoulder and Hand Questionnaire (Quick DASH)
timeFrame: Pre-Surgery (one week)
measure: Disabilities of the Arm Shoulder and Hand Questionnaire (Quick DASH)
timeFrame: One month post-surgery
measure: Disabilities of the Arm Shoulder and Hand Questionnaire (Quick DASH)
timeFrame: Three months post-surgery
measure: Disabilities of the Arm Shoulder and Hand Questionnaire (Quick DASH)
timeFrame: Six months post-surgery
Secondary outcomes:
measure: Upper arm volume
timeFrame: Pre-Surgery (one week)
measure: Upper arm volume
timeFrame: One month post-surgery
measure: Upper arm volume
timeFrame: Three months post-surgery
measure: Upper arm volume
timeFrame: Six months post-surgery
measure: Range of Movement (ROM)
timeFrame: Pre-Surgery (one week)
measure: Range of Movement (ROM)
timeFrame: One month post-surgery
measure: Range of Movement (ROM)
timeFrame: Three months post-surgery
measure: Range of Movement (ROM)
timeFrame: Six months post-surgery
measure: Pain severity
timeFrame: Pre-Surgery (one week)
measure: Pain severity
timeFrame: One month post-surgery
measure: Pain severity
timeFrame: Three months post-surgery
measure: Pain severity
timeFrame: Six months post-surgery
measure: Health-Related Quality of Life
timeFrame: Pre-Surgery (one week)
measure: Health-Related Quality of Life
timeFrame: One month post-surgery
measure: Health-Related Quality of Life
timeFrame: Three months post-surgery
measure: Health-Related Quality of Life
timeFrame: Six months post-surgery
measure: Handgrip Strength
timeFrame: Pre-Surgery (one week)
measure: Handgrip Strength
timeFrame: One month post-surgery
measure: Handgrip Strength
timeFrame: Three months post-surgery
measure: Handgrip Strength
timeFrame: Six months post-surgery
measure: Functional capacity
timeFrame: Pre-surgery (one week)
measure: Functional capacity
timeFrame: One month post-surgery
measure: Functional capacity
timeFrame: Three months post-surgery
measure: Functional capacity
timeFrame: Six months post-surgery
measure: Adherence
timeFrame: Pre-Surgery (one week)
measure: Physical Activity
timeFrame: Pre-surgery (one week)
measure: Physical Activity
timeFrame: One month post-surgery
measure: Physical Activity
timeFrame: Three months post-surgery
measure: Physical Activity
timeFrame: Six months post-surgery
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Santa Creu i Sant Pau
Study officials:
affiliation: School of Health Sciences TecnoCampus. University Pompeu Fabra
name: Raquel Sebio, PhD
role: STUDY_DIRECTOR
References:
citation: Santa Mina D, Brahmbhatt P, Lopez C, Baima J, Gillis C, Trachtenberg L, Silver JK. The Case for Prehabilitation Prior to Breast Cancer Treatment. PM R. 2017 Sep;9(9S2):S305-S316. doi: 10.1016/j.pmrj.2017.08.402.
citation: McNeely ML, Campbell KL, Rowe BH, Klassen TP, Mackey JR, Courneya KS. Effects of exercise on breast cancer patients and survivors: a systematic review and meta-analysis. CMAJ. 2006 Jul 4;175(1):34-41. doi: 10.1503/cmaj.051073.
citation: Silver JK, Baima J. Cancer prehabilitation: an opportunity to decrease treatment-related morbidity, increase cancer treatment options, and improve physical and psychological health outcomes. Am J Phys Med Rehabil. 2013 Aug;92(8):715-27. doi: 10.1097/PHM.0b013e31829b4afe.
citation: Yang A, Sokolof J, Gulati A. The effect of preoperative exercise on upper extremity recovery following breast cancer surgery: a systematic review. Int J Rehabil Res. 2018 Sep;41(3):189-196. doi: 10.1097/MRR.0000000000000288.
citation: ILokapavani Y, Krishna SR, Madhavi K. nfluence of Pre - Operative Physical Therapy Education and Exercise on Post-operative Shoulder Range of Motion and Functional Activites in Subjects with Modified Radical Mastectomy. Int J Physiother 2014. DOI: 10.15621/ijphy/2014/v1i4/54556