Breast CancerNCT04145739
The Sequelae of Mastectomy and Quadrantectomy Respect to the Reaching Movement in Breast Cancer Survivors
A study testing Rehabilitation protocol in people with Breast Cancer and Pain, Chronic, run by University of Roma La Sapienza at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Pain, Chronic, Pain, Postoperative
- What is being tested?
- Rehabilitation protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteItaly
- Study dates
- 23 Apr 2018to 15 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Being tested
- Rehabilitation protocol
- Keywords
- Breast Cancer, Pain, Chronic and Postoperative, Posture, Target - Reaching movement, Mastectomy, Quadrantectomy, Lymphedema, Rehabilitation, Scapula tilting, Shoulder, Biomechanics, Upper limb
- Medical subject headings
- Breast Neoplasms, Chronic Pain, Pain, Postoperative, Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitation protocolOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Mastectomy group | Experimental | Patients undergoing mastectomy Receives: Other: Rehabilitation protocol |
| Quadrantectomy group | Experimental | Patients undergoing quadrantectomy Receives: Other: Rehabilitation protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: T0 baseline - T1 (30 days) - T2 (3 months)
Secondary outcomes (6)
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.
Measured: T0 baseline - T1 (30 days) - T2 (3 months)
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).
Measured: T0 baseline - T1 (30 days) - T2 (3 months)
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.
Measured: T0 baseline - T1 (30 days) - T2 (3 months)
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.
Measured: T0 baseline - T1 (30 days) - T2 (3 months)
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.
Measured: T0 baseline - T1 (30 days) - T2 (3 months)
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.
Measured: T0 baseline - T1 (30 days) - T2 (3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2019
- Study start23 Apr 2018
- Primary completion4 Feb 2019
- Study completion15 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Teresa Paolucci, University of Roma La Sapienza
- Investigators
- Teresa Paolucci, MD, PhD, Principal investigator, University 'Sapienza' of Rome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04145739
- Sponsor's protocol ID
- URomLS-2019
- Status last verified
- Sep 2019
- First submitted
- 23 Oct 2019
- Last updated
- 31 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04145739
- Acronym / sponsor ID
- URomLS-2019
- Keywords
- Breast Cancer, Pain, Chronic and Postoperative, Posture, Target - Reaching movement, Mastectomy, Quadrantectomy, Lymphedema, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- 23 Apr 2018 (actual)
- Primary completion
- 4 Feb 2019 (actual)
- Study completion
- 15 Apr 2019 (actual)
- First posted
- 31 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mastectomy group | Experimental | Other: Rehabilitation protocolPatients undergoing mastectomy |
| Quadrantectomy group | Experimental | Other: Rehabilitation protocolPatients undergoing quadrantectomy |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rehabilitation protocolThe 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. | Other | Mastectomy group, Quadrantectomy group |
Primary outcome
Time variation of the normalized jerk (NJ) within biomechanical reaching movement
Time frame: T0 baseline - T1 (30 days) - T2 (3 months)
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.
6 secondary outcomes
Time variation of Visual Analogue Scale (VAS)
Time frame: T0 baseline - T1 (30 days) - T2 (3 months)
Time variation of Disabilities of Arm, Shoulder and Hand Questionnaire (DASH)
Time frame: T0 baseline - T1 (30 days) - T2 (3 months)
Time variation of Movement Duration (MD) of biomechanical reaching movement
Time frame: T0 baseline - T1 (30 days) - T2 (3 months)
Time variation of the angle of arm flexion at end of movement (AAF) within biomechanical reaching movement
Time frame: T0 baseline - T1 (30 days) - T2 (3 months)
Time variation of the angle at elbow at end of movement (AE) within biomechanical reaching movement
Time frame: T0 baseline - T1 (30 days) - T2 (3 months)
Time variation of the mean value of target-approaching velocity (TAV) within biomechanical reaching movement
Time frame: T0 baseline - T1 (30 days) - T2 (3 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Teresa Paolucci, MD, PhD principal investigator
University 'Sapienza' of Rome
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation protocol in people with Breast Cancer and Pain, Chronic, run by University of Roma La Sapienza at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time variation of the normalized jerk (NJ) within biomechanical reaching movement (time frame: T0 baseline - T1 (30 days) - T2 (3 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2019.