Breast CancerNCT04166279
The Recovery of Reaching Movement in Breast Cancer Survivors: Two Different Rehabilitative Protocols in Comparison
A study testing Single rehabilitative treatment and Group rehabilitative treatment in people with Breast Cancer and Breast Cancer Lymphedema, run by University of Roma La Sapienza at 1 site in Italy.
Trial summary
This study emphasizes the importance of rehabilitation in breast cancer survivors after mastectomy, even during the course of radiotherapy and chemotherapy, both for good efficacy in reducing pain and for functional recovery of the upper limb. 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, Breast Cancer Lymphedema, Pain
- What is being tested?
- Single rehabilitative treatment and Group rehabilitative treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteItaly
- Study dates
- 8 Jan 2018to 19 Jul 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 carried out 12 months prior to recruitment for rehabilitation with breast prostheses or tissue expanders performed
- age from 18 to 60 years
- body mass index (BMI) < 30
- no cognitive dysfunctions ( Mini Mental State Examination MMSE > 24)
Who cannot join
- presence of lymphangitis or mastitis
- presence of metastasis
- surgical complications
- neurological deficits
- shoulder joint problems before surgery
- severe-moderate lymphedema and web axillary syndrome
- visual problem not corrected by lenses
Trial locations and contacts
1 site in 1 country.
About this study
This study emphasizes the importance of rehabilitation in breast cancer survivors after mastectomy, even during the course of radiotherapy and chemotherapy, both for good efficacy in reducing pain and for functional recovery of the upper limb. Authors designed a randomized-controlled trial to compare two different rehabilitation protocols: the single rehabilitative treatment (ST) and the group treatment (GT). The study is the first attempt to measure the reaching movement after BC surgery with an optoelectronic evaluation system previously standardized in the neurological field during rehabilitation treatment.
Read the detailed description
Breast cancer (BC) is the most common cancer in women in the developed world. Surgery and medical protocols have improved significantly over the last 10 years and this guarantees a better chance of survival and an improvement in quality of life.
Then, the focus on "what happen after defeating BC" has become current: patients' and physicians' awareness of the sequelae of BC surgery has increased, especially in the case of mastectomy or modified radical mastectomy. A large number of these complications, such as lymphedema or post-treatment pain with or without functional impotence, which contribute to limitations in daily life activities, can be treated favourably and, in sometimes, resolved with early rehabilitation protocols. Therefore, it is not only important to start the rehabilitation process early after surgery, but, also, during the sub-acute phase, choose appropriate exercise programs to allow recovery in "quantity" and "quality" of the movement of the operated upper limb (UL). Alterations in muscle activation and reduced shoulder mobility are common in patients with BC. It is necessary to consider that winged scapula incidence in BC surgery is 8% and the prevalence decreased during 6 months after surgery. In particular, patients who developed winged scapula had more shoulder flexion, adduction and abduction limitation. These findings suggest that, after BC surgery, soft tissues restrictions obstruct short-term scapula motion.
Reaching movement is a complex multi-articular movement towards a defined point in space and allows the hand to interact with the environment. Nevertheless, it is not yet investigated during the rehabilitation process. Moreover, the execution of the UL movements, improves if the numerous perturbations of the musculoskeletal system, which occur during the execution of movements, are compensated. Motor synergy's components should modify their action to influence positively the outcome of motor activity, preventing the mistakes of the individual components from influencing the overall activity. An important issue is represented by the redundancy of the degrees of motor freedom. Actions and movements can be performed in different ways because the functional synergies are able to co-vary, without changing the result of the action. However, only three spatial dimensions are needed to specify any position where the hand could be placed. This excess of kinematic degrees of freedom means that there are multiple arm configurations that correspond to any particular position of the hand. Thus, improvements in reaching, after BC mastectomy, can be determined, compared to a different rehabilitation protocol, by comparing the Single rehabilitative Treatment (ST) with Group Treatment (GT). Authors designed a randomized-controlled trial to check if specific scapula exercises, included in the ST, could induce changes in the fluidity of the reaching, called Jerk (primary outcome), decrease shoulder pain and improve the functioning of the operated upper limb (secondary outcomes).
- Conditions
- Breast Cancer, Breast Cancer Lymphedema, Pain, Pain, Postoperative, Pain, Chronic, Mastectomy; Lymphedema
- Being tested
- Single rehabilitative treatment, Group rehabilitative treatment
- Keywords
- Breast Cancer, Pain Chronic and Postoperative, Lymphedema, Posture, Target - Reaching movement, Breast surgery, Functional impotence, Rehabilitive treatment, Physiotherapy, Scapula tilting
- Medical subject headings
- Breast Neoplasms, Breast Cancer Lymphedema, Pain, Pain, Postoperative, Chronic Pain, Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single rehabilitative treatmentOther
The rehabilitation treatment, performed by a physiotherapist trained in oncological rehabilitation, was carried out with a 6-week exercise program for 12 sessions (60 minutes/session, 2/week).). The protocol included a first phase consist in low impact aerobics warming (15-20 minutes), then diaphragmatic breathing and postural exercises for the midline alignment. The awareness of abdominal breathing represents the preliminary phase for a complete psychophysical relaxation of the patient, an important prerequisite for the correct execution of subsequent mobility, stretching and strengthening exercises of spine, scapula and upper limb. Subsequently, isometric strengthening exercises for shoulder stabilizing muscles, first passively and, subsequently, with supervision, were performed. Specific exercises, for passive mobilization and stabilization of the scapula, cervical pumping and stretching of the pectoral muscles, have been performed.
Group rehabilitative treatmentOther
Four-five patients for group. The rehabilitation treatment, performed by a physiotherapist trained in oncological rehabilitation, was carried out with a 6-week exercise program for 12 sessions (60 minutes/session, 2/week). The protocol included at first week mainly breathing techniques, then we introduced exercises gradually more active, according to the improvements of the execution. The exercises had the aim to improve the opening of the scapular chain and to increase the amplitude of the range of motion in order to stimulate better neuromuscular control during the movement of scapular retropulsion, to stretch the pectoral muscles following the rhythm of the breath and the tissues affected by post-surgical scars and fibrotic effects, finally to reinforcing, against gravity, the musculature of the shoulders and back.
| Study group | Role | What they receive |
|---|---|---|
| Single rehabilitative Treatment | Experimental | Patients treated within single rehabilitative protocol Receives: Other: Single rehabilitative treatment |
| Group rehabilitative Treatment | Experimental | Patients treated within group rehabilitative protocol Receives: Other: Group rehabilitative treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change [over time] 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 (6 weeks) - T2 (3 months)
Secondary outcomes (6)
Change [over time] 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 (6 weeks) - T2 (3 months)
Change [over time] 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, activityrelated 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 (6 weeks) - T2 (3 months)
Change [over time] 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 (6 weeks) - T2 (3 months)
Change [over time] 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 stereophotogrammetric 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 (6 weeks) - T2 (3 months)
Change [over time] 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 stereophotogrammetric 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 (6 weeks) - T2 (3 months)
Change [over time] 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 (6 weeks) - 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 posted18 Nov 2019
- Study start8 Jan 2018
- Primary completion15 Apr 2019
- Study completion19 Jul 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
- 66 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04166279
- Sponsor's protocol ID
- URomLS-2019a
- Status last verified
- Nov 2019
- First submitted
- 13 Nov 2019
- Last updated
- 19 Nov 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 19 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Recovery of Reaching Movement in Breast Cancer Survivors: Two Different Rehabilitative Protocols in Comparison
- ClinicalTrials.gov ID
- NCT04166279
- Acronym / sponsor ID
- URomLS-2019a
- Conditions
- Breast Cancer, Breast Cancer Lymphedema, Pain, Pain, Postoperative, Pain, Chronic, Mastectomy; Lymphedema
- Keywords
- Breast Cancer, Pain Chronic and Postoperative, Lymphedema, Posture, Target - Reaching movement, Breast surgery, Functional impotence, Rehabilitive treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- 8 Jan 2018 (actual)
- Primary completion
- 15 Apr 2019 (actual)
- Study completion
- 19 Jul 2019 (actual)
- First posted
- 18 Nov 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.
This study emphasizes the importance of rehabilitation in breast cancer survivors after mastectomy, even during the course of radiotherapy and chemotherapy, both for good efficacy in reducing pain and for functional recovery of the upper limb. Authors designed a randomized-controlled trial to compare two different rehabilitation protocols: the single rehabilitative treatment (ST) and the group treatment (GT). The study is the first attempt to measure the reaching movement after BC surgery with an optoelectronic evaluation system previously standardized in the neurological field during rehabilitation treatment.
Detailed description
Breast cancer (BC) is the most common cancer in women in the developed world. Surgery and medical protocols have improved significantly over the last 10 years and this guarantees a better chance of survival and an improvement in quality of life.
Then, the focus on "what happen after defeating BC" has become current: patients' and physicians' awareness of the sequelae of BC surgery has increased, especially in the case of mastectomy or modified radical mastectomy. A large number of these complications, such as lymphedema or post-treatment pain with or without functional impotence, which contribute to limitations in daily life activities, can be treated favourably and, in sometimes, resolved with early rehabilitation protocols. Therefore, it is not only important to start the rehabilitation process early after surgery, but, also, during the sub-acute phase, choose appropriate exercise programs to allow recovery in "quantity" and "quality" of the movement of the operated upper limb (UL). Alterations in muscle activation and reduced shoulder mobility are common in patients with BC. It is necessary to consider that winged scapula incidence in BC surgery is 8% and the prevalence decreased during 6 months after surgery. In particular, patients who developed winged scapula had more shoulder flexion, adduction and abduction limitation. These findings suggest that, after BC surgery, soft tissues restrictions obstruct short-term scapula motion.
Reaching movement is a complex multi-articular movement towards a defined point in space and allows the hand to interact with the environment. Nevertheless, it is not yet investigated during the rehabilitation process. Moreover, the execution of the UL movements, improves if the numerous perturbations of the musculoskeletal system, which occur during the execution of movements, are compensated. Motor synergy's components should modify their action to influence positively the outcome of motor activity, preventing the mistakes of the individual components from influencing the overall activity. An important issue is represented by the redundancy of the degrees of motor freedom. Actions and movements can be performed in different ways because the functional synergies are able to co-vary, without changing the result of the action. However, only three spatial dimensions are needed to specify any position where the hand could be placed. This excess of kinematic degrees of freedom means that there are multiple arm configurations that correspond to any particular position of the hand. Thus, improvements in reaching, after BC mastectomy, can be determined, compared to a different rehabilitation protocol, by comparing the Single rehabilitative Treatment (ST) with Group Treatment (GT). Authors designed a randomized-controlled trial to check if specific scapula exercises, included in the ST, could induce changes in the fluidity of the reaching, called Jerk (primary outcome), decrease shoulder pain and improve the functioning of the operated upper limb (secondary outcomes).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single rehabilitative Treatment | Experimental | Other: Single rehabilitative treatmentPatients treated within single rehabilitative protocol |
| Group rehabilitative Treatment | Experimental | Other: Group rehabilitative treatmentPatients treated within group rehabilitative protocol |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- total mastectomy carried out 12 months prior to recruitment for rehabilitation with breast prostheses or tissue expanders performed
- age from 18 to 60 years
- body mass index (BMI) < 30
- no cognitive dysfunctions ( Mini Mental State Examination MMSE > 24)
Key exclusion criteria (7 listed)
- presence of lymphangitis or mastitis
- presence of metastasis
- surgical complications
- neurological deficits
- shoulder joint problems before surgery
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 |
|---|---|---|
| Single rehabilitative treatmentThe rehabilitation treatment, performed by a physiotherapist trained in oncological rehabilitation, was carried out with a 6-week exercise program for 12 sessions (60 minutes/session, 2/week).). The protocol included a first phase consist in low impact aerobics warming (15-20 minutes), then diaphragmatic breathing and postural exercises for the midline alignment. The awareness of abdominal breathing represents the preliminary phase for a complete psychophysical relaxation of the patient, an important prerequisite for the correct execution of subsequent mobility, stretching and strengthening exercises of spine, scapula and upper limb. Subsequently, isometric strengthening exercises for shoulder stabilizing muscles, first passively and, subsequently, with supervision, were performed. Specific exercises, for passive mobilization and stabilization of the scapula, cervical pumping and stretching of the pectoral muscles, have been performed. | Other | Single rehabilitative Treatment |
| Group rehabilitative treatmentFour-five patients for group. The rehabilitation treatment, performed by a physiotherapist trained in oncological rehabilitation, was carried out with a 6-week exercise program for 12 sessions (60 minutes/session, 2/week). The protocol included at first week mainly breathing techniques, then we introduced exercises gradually more active, according to the improvements of the execution. The exercises had the aim to improve the opening of the scapular chain and to increase the amplitude of the range of motion in order to stimulate better neuromuscular control during the movement of scapular retropulsion, to stretch the pectoral muscles following the rhythm of the breath and the tissues affected by post-surgical scars and fibrotic effects, finally to reinforcing, against gravity, the musculature of the shoulders and back. | Other | Group rehabilitative Treatment |
Primary outcome
Change [over time] of the normalized jerk (NJ) within biomechanical reaching movement
Time frame: T0 baseline - T1 (6 weeks) - 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
Change [over time] of Visual Analogue Scale (VAS)
Time frame: T0 baseline - T1 (6 weeks) - T2 (3 months)
Change [over time] of Disabilities of Arm, Shoulder and Hand Questionnaire (DASH)
Time frame: T0 baseline - T1 (6 weeks) - T2 (3 months)
Change [over time] of Movement Duration (MD) of biomechanical reaching movement
Time frame: T0 baseline - T1 (6 weeks) - T2 (3 months)
Change [over time] of the angle of arm flexion at end of movement (AAF) within biomechanical reaching movement
Time frame: T0 baseline - T1 (6 weeks) - T2 (3 months)
Change [over time] of the angle at elbow at end of movement (AE) within biomechanical reaching movement
Time frame: T0 baseline - T1 (6 weeks) - T2 (3 months)
Change [over time] of the mean value of target-approaching velocity (TAV) within biomechanical reaching movement
Time frame: T0 baseline - T1 (6 weeks) - 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 19 Nov 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single rehabilitative treatment and Group rehabilitative treatment in people with Breast Cancer and Breast Cancer Lymphedema, 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 4 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 19 Nov 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?
Change [over time] of the normalized jerk (NJ) within biomechanical reaching movement (time frame: T0 baseline - T1 (6 weeks) - 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 19 Nov 2019.