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Mechanical Stimulation on Pain Level and Functional Discomfort After Breast Cancer Surgery

Primary Purpose

Breast Cancer

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Mechanical Stimulation
Massages
Sponsored by
Centre Oscar Lambret
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring Breast Cancer, Mechanical Stimulation, Mastectomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Age > 18 years
  • Patient who had total mastectomy for a breast cancer or pre-cancerous lesions
  • Associated with axillary dissection or removal of the sentinel lymph nodes
  • Presenting with functional discomfort and/or pain at the control consultation, 3 weeks after the mastectomy and justifying the prescription of physiotherapy
  • Possibility to be treated by a physiotherapist who can carry out both techniques and accepts to perform either one of the techniques according to the randomized allocation of the treatment
  • Patient covered by the French social security regime
  • Signed and informed consent

Exclusion Criteria:

  • Immediate breast reconstruction
  • Total bilateral mastectomy
  • Contraindication to mechanical stimulation technique
  • Patient who are planning to move houses in the next 6 months
  • Patients under guardianship

Sites / Locations

  • Centre Oscar LambretRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Arm A - Mechanical Stimulation

Arm B - Massages

Arm Description

Patients in this arm will receive, in addition to standard rehabilitation physiotherapy, mechanical stimulation

Patients in this arm will receive, in addition to standard rehabilitation physiotherapy, massages.

Outcomes

Primary Outcome Measures

Pain level by a numerical scale
Pain level will be evaluated using a numerical scale of pain
Pain level by using Brief Pain Inventory
Pain level will be evaluated using Brief Pain Inventory (BPI), there is no global score for this questionnaire, each item must be considered separately.
Pain level by using QDN4 questionnaire
Pain level will be evaluated using QDN4 questionnaire, which is a pain scale from 0 to 10.
Mobility of the shoulders
Will be evaluated using the Constant score based on the study by Constant CR, Murley AHG. A clinical method of functional assessment of the shoulder. Clin Orthop Relat Res 1987;(214):160-4. Pain level, level of daily activities and physical mobility will be assessed with a a scale adapted according to the gender and the patients age.

Secondary Outcome Measures

Pain level by a numerical scale
Pain level will be evaluated using a numerical scale of pain
Pain level by using Brief Pain Inventory
Pain level will be evaluated using Brief Pain Inventory (BPI), there is no global score for this questionnaire, each item must be considered separately.
Pain level by using QDN4 questionnaire
Pain level will be evaluated using QDN4 questionnaire, which is a pain scale from 0 to 10.
Mobility of the shoulders
Will be evaluated using the Constant score based on the study by Constant CR, Murley AHG. A clinical method of functional assessment of the shoulder. Clin Orthop Relat Res 1987;(214):160-4. Pain level, level of daily activities and physical mobility will be assessed with a a scale adapted according to the gender and the patients age.
Anxiety
Will be evaluated using the Hospital Anxiety and Depression Scale (HADS) questionnaire. The questionnaire consists of a list of questions to determine the level of anxiety and depression experienced by the patients. Each question is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression: A score equal to or less than 7 indicates no symptoms, A score of 8 - 10 indicates a questionable symptoms, A score of 11 and above confirms of the presence of anxiety and/or depression symptoms
Quality of Life (QoL) with EORTC-QLQ-C30
Will be evaluated using the EORTC-QLQ-C30 questionnaire. This questionnaire aim to assess the quality of life of cancer. It is composed of 30 questions. In this questionnaire, the items are scored from 1-4, where 1 = not at all, 2 = a little, 3 = quite a bit and 4 = very much. Only 2 items in the EORTC-QLQ-C30 questionnaire are scored from 1-7, where 1 is very poor and 7 is excellent.
Quality of Life (QoL) with EORTC-QLQ-BR23
Will be evaluated using the EORTC-QLQ-BR23 questionnaire. This questionnaire aim to assess the quality of life of cancer. It is composed of 23 questions. In this questionnaire, the items are scored from 1-4, where 1 = not at all, 2 = a little, 3 = quite a bit and 4 = very much.

Full Information

First Posted
June 5, 2019
Last Updated
July 27, 2021
Sponsor
Centre Oscar Lambret
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1. Study Identification

Unique Protocol Identification Number
NCT04202640
Brief Title
Mechanical Stimulation on Pain Level and Functional Discomfort After Breast Cancer Surgery
Official Title
Effectiveness of Mechanical Stimulation on Pain Level and Functional Discomfort Following a Total Mastectomy and Exploratory Axillary Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Recruiting
Study Start Date
May 27, 2020 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Oscar Lambret

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study evaluates the effectiveness of mechanical stimulation technique compared to massages on pain level and functional discomfort (on the mobility of the shoulder) after 6 months, in breast cancer needing physiotherapy, following a total mastectomy and exploratory axillary surgery.
Detailed Description
A prospective, monocentric, randomized, open-labelled in two parallel groups study that evaluates the effectiveness of mechanical stimulation technique compared to massages on pain level and functional discomfort (on the mobility of the shoulder) after 6 months in breast cancer patients needing physiotherapy, following a total mastectomy and exploratory axillary surgery. Other objectives of the study include: Evaluate the efficacy of mechanical stimulation technique compared to massages on pain and functional discomfort (on the mobility of the shoulder) 15 days after the end of physiotherapy. Evaluate the impact of mechanical stimulation on the quality of life of patients, in comparison to those receiving massages

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast Cancer, Mechanical Stimulation, Mastectomy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A - Mechanical Stimulation
Arm Type
Experimental
Arm Description
Patients in this arm will receive, in addition to standard rehabilitation physiotherapy, mechanical stimulation
Arm Title
Arm B - Massages
Arm Type
Sham Comparator
Arm Description
Patients in this arm will receive, in addition to standard rehabilitation physiotherapy, massages.
Intervention Type
Procedure
Intervention Name(s)
Mechanical Stimulation
Intervention Description
The technique of mechanical stimulation alternates between compression and decompression of the treated area. It aims to reestablish a good blood circulation and lymphatic drainage.
Intervention Type
Procedure
Intervention Name(s)
Massages
Intervention Description
Massages will be carried out according to a specific regime as specified in the study protocol. The massages will be done in 15 sessions of 30 minutes each, done twice a week and will consist of: One part muscle exercise One part skin work (drainage)
Primary Outcome Measure Information:
Title
Pain level by a numerical scale
Description
Pain level will be evaluated using a numerical scale of pain
Time Frame
6 months after randomization
Title
Pain level by using Brief Pain Inventory
Description
Pain level will be evaluated using Brief Pain Inventory (BPI), there is no global score for this questionnaire, each item must be considered separately.
Time Frame
6 months after randomization
Title
Pain level by using QDN4 questionnaire
Description
Pain level will be evaluated using QDN4 questionnaire, which is a pain scale from 0 to 10.
Time Frame
6 months after randomization
Title
Mobility of the shoulders
Description
Will be evaluated using the Constant score based on the study by Constant CR, Murley AHG. A clinical method of functional assessment of the shoulder. Clin Orthop Relat Res 1987;(214):160-4. Pain level, level of daily activities and physical mobility will be assessed with a a scale adapted according to the gender and the patients age.
Time Frame
6 months after randomization
Secondary Outcome Measure Information:
Title
Pain level by a numerical scale
Description
Pain level will be evaluated using a numerical scale of pain
Time Frame
15 days after the end of physiotherapy
Title
Pain level by using Brief Pain Inventory
Description
Pain level will be evaluated using Brief Pain Inventory (BPI), there is no global score for this questionnaire, each item must be considered separately.
Time Frame
15 days after the end of physiotherapy
Title
Pain level by using QDN4 questionnaire
Description
Pain level will be evaluated using QDN4 questionnaire, which is a pain scale from 0 to 10.
Time Frame
15 days after the end of physiotherapy
Title
Mobility of the shoulders
Description
Will be evaluated using the Constant score based on the study by Constant CR, Murley AHG. A clinical method of functional assessment of the shoulder. Clin Orthop Relat Res 1987;(214):160-4. Pain level, level of daily activities and physical mobility will be assessed with a a scale adapted according to the gender and the patients age.
Time Frame
15 days after the end of physiotherapy
Title
Anxiety
Description
Will be evaluated using the Hospital Anxiety and Depression Scale (HADS) questionnaire. The questionnaire consists of a list of questions to determine the level of anxiety and depression experienced by the patients. Each question is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression: A score equal to or less than 7 indicates no symptoms, A score of 8 - 10 indicates a questionable symptoms, A score of 11 and above confirms of the presence of anxiety and/or depression symptoms
Time Frame
at the baseline and 6 months after
Title
Quality of Life (QoL) with EORTC-QLQ-C30
Description
Will be evaluated using the EORTC-QLQ-C30 questionnaire. This questionnaire aim to assess the quality of life of cancer. It is composed of 30 questions. In this questionnaire, the items are scored from 1-4, where 1 = not at all, 2 = a little, 3 = quite a bit and 4 = very much. Only 2 items in the EORTC-QLQ-C30 questionnaire are scored from 1-7, where 1 is very poor and 7 is excellent.
Time Frame
at the baseline and 6 months after
Title
Quality of Life (QoL) with EORTC-QLQ-BR23
Description
Will be evaluated using the EORTC-QLQ-BR23 questionnaire. This questionnaire aim to assess the quality of life of cancer. It is composed of 23 questions. In this questionnaire, the items are scored from 1-4, where 1 = not at all, 2 = a little, 3 = quite a bit and 4 = very much.
Time Frame
at the baseline and 6 months after

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age > 18 years Patient who had total mastectomy for a breast cancer or pre-cancerous lesions Associated with axillary dissection or removal of the sentinel lymph nodes Presenting with functional discomfort and/or pain at the control consultation, 3 weeks after the mastectomy and justifying the prescription of physiotherapy Possibility to be treated by a physiotherapist who can carry out both techniques and accepts to perform either one of the techniques according to the randomized allocation of the treatment Patient covered by the French social security regime Signed and informed consent Exclusion Criteria: Immediate breast reconstruction Total bilateral mastectomy Contraindication to mechanical stimulation technique Patient who are planning to move houses in the next 6 months Patients under guardianship
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fanny BEN OUNE
Phone
+33 (0)3 20 29 59 18
Email
promotion@o-lambret.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claudia REGIS, MD
Organizational Affiliation
Centre Oscar Lambret
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Oscar Lambret
City
Lille
State/Province
Hauts-de- France
ZIP/Postal Code
59020
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claudia REGIS, MD
Phone
+33 (0)3 20 29 59 35
Email
c-regis@o-lambret.fr
First Name & Middle Initial & Last Name & Degree
Claudia REGIS, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Mechanical Stimulation on Pain Level and Functional Discomfort After Breast Cancer Surgery

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