Prevention of Sequelae Pain After Breast Cancer Surgery by Self-massages and Self Stretching. Impact of Learning Workshops.

Breast Cancer Clinical Trial

— ESTAUVAL  

Official title:

Prevention of Sequelae Pain After Breast Cancer Surgery by Daily Self Massages and Self Stretching of Serratus Anterior Muscle, Pectoralis Major Muscle, Infraspinatus Muscle and Latissimus Dorsi Muscle: Impact of Learning Workshops Performed by a Multidisciplinary Team.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03651973
• Other study ID #: 2015-4-6-003
• Status: Recruiting
• Phase: N/A
• Start date: January 13, 2020
• Est. completion date: August 31, 2025

Study information

• Verified date: January 2024
• Source: Center Eugene Marquis
• Contact: Aurélie THEBAULT
• Phone: +33 2 99 25 30 00
• Email: a.thebault[@]rennes.unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Myofascial pain syndrome is a common cause of chronic pain characterized by myofascial pain and trigger points. Recommendations regarding management of pain after breast cancer don't mention myofascial syndrome despite a study suggests possible myofascial syndrome with roughly 75% of patients in pain. 144 patients having a local breast cancer requiring surgery will be randomized in this study, ratio 1:1 standard and experimental groups. Every patients (standard and experimental groups) will attend 4 specific consultations during which standard recommendations will be given, pain, quality of life, shoulder range of motion, global upper limbs force will be assessed. In addition, patient randomized in experimental group will attend self massages and self stretching workshops, one before surgery and one after surgery. Patients will be encouraged to performed daily self massages and self stretching. The aim of the study is to assess impact of self massages and self stretching workshops on sequelae pain further surgery for breast cancer.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 144
• Est. completion date: August 31, 2025
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Woman
• Local development of breast cancer, every stages except stage IV
• Indication of surgery whatever surgery type except breast reconstruction
• More than18 years
• Life expectancy > 12 months assessed by surgeon or pain specialist
• Informed and written consent
• Affiliated to a social security system

Exclusion Criteria:

• History of chronic pain
• History of shoulder pain
• Any illness or severe disease, medical or psychiatric, that could prevent the patient to follow study procedures or to give her informed consent, according investigators,
• History of breast surgery
• Pregnant or lactating woman
• Protected adult or deprived of her liberty

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Surgery

Intervention

Other:
• Standard follow-up
Patients enrolled into standard group will be followed in a standard way without any additional procedure except randomization that allocates to the standard group
• Learning workshops
Patients enrolled into experimental arm will participate to educative workshops before and after surgery for breast cancer. The aim of these workshop is to educate patient to self massages and self stretching.

Locations

Country	Name	City	State
France	Centre Eugène Marquis	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Center Eugene Marquis

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Impact of Learning workshops (self massages and self stretching) on sequelae pain after breast cancer surgery	Number of patients with chronic pain	For 12 months after surgery
Secondary	Impact of patient quality of life	Assessed by EORTC Quality of Life Questionnaire Core questionnaire 30 scale	at 3, 6 and 12 months