The Sequelae of Mastectomy and Quadrantectomy Respect to the Reaching Movement in Breast Cancer Survivors
Primary Purpose
Breast Cancer, Pain, Chronic, Pain, Postoperative
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Rehabilitation protocol
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring Breast Cancer, Pain, Chronic and Postoperative, Posture, Target - Reaching movement, Mastectomy, Quadrantectomy, Lymphedema, Rehabilitation, Scapula tilting, Shoulder, Biomechanics, Upper limb
Eligibility Criteria
Inclusion Criteria:
- total mastectomy with breast prostheses or tissue expanders performed or quadrantectomy
- age from 18 to 60 years
- body mass index (BMI) < 30
- no cognitive dysfunctions ( Mini Mental State Examination MMSE > 24)
- mild lymphedema
Exclusion Criteria:
- presence of lymphangitis or mastitis
- presence of metastasis
- surgical complications of the intervention, neurological deficits and complications
- important shoulder joint problems before the intervention for BC
- severe-moderate lymphedema and web axillary syndrome
- visual problem not corrected by lenses
- other or previous physiotherapy
Sites / Locations
- Umberto I Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Mastectomy group
Quadrantectomy group
Arm Description
Patients undergoing mastectomy
Patients undergoing quadrantectomy
Outcomes
Primary Outcome Measures
Time variation of the normalized jerk (NJ) within biomechanical reaching movement
The normalized jerk (NJ) was evaluated through the Smart D500 stereo-photogrammetric system (BTS, Italy), calculated on the wrist-target marker distance, within the reaching task performed on the side underwent surgery. It measures the fluidity of the upper limb movement.
Secondary Outcome Measures
Time variation of Visual Analogue Scale (VAS)
Instrument to assess unidimensional measure of pain intensity. VAS was presented in a coloured scale with a middle point, graduations and numbers. Under the scale there was a straight horizontal line of fixed length, 100 mm. The ends were defined as the limits of the parameter to be measured (pain in the last 24 hours), orientated from the left (worst, no pain) to the right (best, worst pain to be imagined). The score is determined by measuring the distance (cm) on the 10 cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-10.
Time variation of Disabilities of Arm, Shoulder and Hand Questionnaire (DASH)
Self-administered region-specific outcome instrument developed as a measure of self-rated upper-limb disability and symptoms, actually used to monitor changes in symptoms and function over time. It consists mainly of a 30-item disability/symptom scale, scored 0 (no disability) to 100. The items are related to the degree of difficulty in performing various functional activities because of arm, shoulder or hand limitations (21 items), the intensity of pain, activity-related pain, tingling, weakness and stiffness (5 items), and the effect related to social activities, job, sleep and its psychological impact (4 items).
Time variation of Movement Duration (MD) of biomechanical reaching movement
The movement duration (MD) was evaluated in seconds, through the Smart D500 stereo-photogrammetric system (BTS, Italy), within the reaching task performed on the side underwent surgery.
Time variation of the angle of arm flexion at end of movement (AAF) within biomechanical reaching movement
The degrees of the angle of arm flexion at end of movement (AAF) were evaluated through the Smart D500 stereo-photogrammetric system (BTS, Italy), within the reaching task performed on the side underwent surgery. A zero value is conventionally assigned to AAF when the arm is along the side, positive values represent flexion, negative ones represent extension.
Time variation of the angle at elbow at end of movement (AE) within biomechanical reaching movement
The degrees of the angle at elbow at end of movement (AE) were evaluated through the Smart D500 stereo-photogrammetric system (BTS, Italy), within the reaching task performed on the side underwent surgery. The value assigned is zero when the elbow is completely extended, positive values correspond to flexion, and negative ones to hyperextension.
Time variation of the mean value of target-approaching velocity (TAV) within biomechanical reaching movement
The mean value of target-approaching velocity (TAV) was evaluated through the Smart D500 stereo-photogrammetric system (BTS, Italy), within the reaching task performed on the side underwent surgery.
Full Information
NCT ID
NCT04145739
First Posted
October 23, 2019
Last Updated
October 29, 2019
Sponsor
University of Roma La Sapienza
1. Study Identification
Unique Protocol Identification Number
NCT04145739
Brief Title
The Sequelae of Mastectomy and Quadrantectomy Respect to the Reaching Movement in Breast Cancer Survivors
Official Title
The Sequelae of Mastectomy and Quadrantectomy Respect to the Reaching Movement in Breast Cancer Survivors: the Evidences of an Integrated Rehabilitation Protocol During the Oncological Care Path
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
April 23, 2018 (Actual)
Primary Completion Date
February 4, 2019 (Actual)
Study Completion Date
April 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Roma La Sapienza
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
The hypothesis behind our study was that patients after BC surgery, who underwent quadrantectomy or mastectomy, may present a different disability respect to the upper limb on the operated side. Accordingly they could have a different functional recovery patterns after rehabilitation.
The aim of our study was to compare the recovery of the fluidity of the reaching movement (Jerk) as the primary outcome, the reduction of shoulder pain and improvement of disability for the upper limb respect the operated side as secondary outcomes, before and after a specific rehabilitation protocol treatment.
Detailed Description
Surgery is usually the first line of attack against breast cancer (BC). The decisions about surgery depend on many factors based on the stage, the type of cancer and patient acceptability, in terms of her long term peace of mind and survival prospects. Typically, breast reconstruction takes place during or soon after mastectomy, to avoid psychological distress for the patient, and in some cases, also after lumpectomy or quadrantectomy; furthermore breast reconstruction can be done many months or even years after surgery too.
Today, breast cancer rehabilitation can help survivors to obtain and maintain the highest possible physical, social, psychological and vocational functioning, within the limits created by cancer and its treatments. After BC surgery, is common to detect disorders as shoulder dysfunction, postmastectomy syndrome, chemotherapy-induced peripheral neuropathy, axillary cording, lymphedema and a host of others as postural imbalance.
Also, alterations in muscle activation and restricted shoulder mobility, which are common in BC patients, have been found to affect upper limb function and alterations in muscle activity patterns differed by breast surgery and reconstruction type: rehabilitation and in particular mobilization stretches and shoulder and scapula exercises after breast surgery are an effective resource to improve upper limb range of motion and decrease chest tightness and pain.
This study was prompted by the lack of literature about the quadrantectomy versus mastectomy intervention, considering the disability of the upper limb from the operated side, especially if in relation to the rehabilitation pathway, currently recommended in BC care.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Pain, Chronic, Pain, Postoperative, Mastectomy; Lymphedema
Keywords
Breast Cancer, Pain, Chronic and Postoperative, Posture, Target - Reaching movement, Mastectomy, Quadrantectomy, Lymphedema, Rehabilitation, Scapula tilting, Shoulder, Biomechanics, Upper limb
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mastectomy group
Arm Type
Experimental
Arm Description
Patients undergoing mastectomy
Arm Title
Quadrantectomy group
Arm Type
Experimental
Arm Description
Patients undergoing quadrantectomy
Intervention Type
Other
Intervention Name(s)
Rehabilitation protocol
Intervention Description
The rehabilitation treatment was performer in single session, lasted 60 minutes for session, 2 times a week, carried-out a 6-week exercises program for a total of 12 sessions, by a physiotherapist trained in oncologic rehabilitation, who started with a first phase of at least 15-20 min of low-impact aerobics warm-up. The second phase consisted in diaphragmatic breathing and postural exercises for the midline alignment in a supine position. Finally the patient continued in front of the mirror with exercises for the recovery of shoulder joint, isometric reinforcement exercises for the recovery of strength of shoulder stabilizer muscles. In the presence of lymphedema an additional weekly lymph drainage session was performed for a total of 10 sessions.
Primary Outcome Measure Information:
Title
Time variation of the normalized jerk (NJ) within biomechanical reaching movement
Description
The normalized jerk (NJ) was evaluated through the Smart D500 stereo-photogrammetric system (BTS, Italy), calculated on the wrist-target marker distance, within the reaching task performed on the side underwent surgery. It measures the fluidity of the upper limb movement.
Time Frame
T0 baseline - T1 (30 days) - T2 (3 months)
Secondary Outcome Measure Information:
Title
Time variation of Visual Analogue Scale (VAS)
Description
Instrument to assess unidimensional measure of pain intensity. VAS was presented in a coloured scale with a middle point, graduations and numbers. Under the scale there was a straight horizontal line of fixed length, 100 mm. The ends were defined as the limits of the parameter to be measured (pain in the last 24 hours), orientated from the left (worst, no pain) to the right (best, worst pain to be imagined). The score is determined by measuring the distance (cm) on the 10 cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-10.
Time Frame
T0 baseline - T1 (30 days) - T2 (3 months)
Title
Time variation of Disabilities of Arm, Shoulder and Hand Questionnaire (DASH)
Description
Self-administered region-specific outcome instrument developed as a measure of self-rated upper-limb disability and symptoms, actually used to monitor changes in symptoms and function over time. It consists mainly of a 30-item disability/symptom scale, scored 0 (no disability) to 100. The items are related to the degree of difficulty in performing various functional activities because of arm, shoulder or hand limitations (21 items), the intensity of pain, activity-related pain, tingling, weakness and stiffness (5 items), and the effect related to social activities, job, sleep and its psychological impact (4 items).
Time Frame
T0 baseline - T1 (30 days) - T2 (3 months)
Title
Time variation of Movement Duration (MD) of biomechanical reaching movement
Description
The movement duration (MD) was evaluated in seconds, through the Smart D500 stereo-photogrammetric system (BTS, Italy), within the reaching task performed on the side underwent surgery.
Time Frame
T0 baseline - T1 (30 days) - T2 (3 months)
Title
Time variation of the angle of arm flexion at end of movement (AAF) within biomechanical reaching movement
Description
The degrees of the angle of arm flexion at end of movement (AAF) were evaluated through the Smart D500 stereo-photogrammetric system (BTS, Italy), within the reaching task performed on the side underwent surgery. A zero value is conventionally assigned to AAF when the arm is along the side, positive values represent flexion, negative ones represent extension.
Time Frame
T0 baseline - T1 (30 days) - T2 (3 months)
Title
Time variation of the angle at elbow at end of movement (AE) within biomechanical reaching movement
Description
The degrees of the angle at elbow at end of movement (AE) were evaluated through the Smart D500 stereo-photogrammetric system (BTS, Italy), within the reaching task performed on the side underwent surgery. The value assigned is zero when the elbow is completely extended, positive values correspond to flexion, and negative ones to hyperextension.
Time Frame
T0 baseline - T1 (30 days) - T2 (3 months)
Title
Time variation of the mean value of target-approaching velocity (TAV) within biomechanical reaching movement
Description
The mean value of target-approaching velocity (TAV) was evaluated through the Smart D500 stereo-photogrammetric system (BTS, Italy), within the reaching task performed on the side underwent surgery.
Time Frame
T0 baseline - T1 (30 days) - T2 (3 months)
Other Pre-specified Outcome Measures:
Title
Time variation of range of Motion (ROM) of shoulder
Description
The degrees of flexion, extension, adduction, abduction and internal and external rotation evaluated on the side underwent surgery.
Time Frame
T0 baseline - T1 (30 days) - T2 (3 months)
Title
Time variation of muscular strength regards shoulder ROM
Description
Parameters evaluated according to the scale of Medical Research Council Manual Muscle Testing (MRC), on a scale of 0 to 5 in relation to the maximum expected for that muscle.
Time Frame
T0 baseline - T1 (30 days) - T2 (3 months)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
total mastectomy with breast prostheses or tissue expanders performed or quadrantectomy
age from 18 to 60 years
body mass index (BMI) < 30
no cognitive dysfunctions ( Mini Mental State Examination MMSE > 24)
mild lymphedema
Exclusion Criteria:
presence of lymphangitis or mastitis
presence of metastasis
surgical complications of the intervention, neurological deficits and complications
important shoulder joint problems before the intervention for BC
severe-moderate lymphedema and web axillary syndrome
visual problem not corrected by lenses
other or previous physiotherapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Teresa Paolucci, MD, PhD
Organizational Affiliation
University 'Sapienza' of Rome
Official's Role
Principal Investigator
Facility Information:
Facility Name
Umberto I Hospital
City
Rome
ZIP/Postal Code
00165
Country
Italy
12. IPD Sharing Statement
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The Sequelae of Mastectomy and Quadrantectomy Respect to the Reaching Movement in Breast Cancer Survivors
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