Breast NeoplasmsNCT03389204
Upper Limb Function After Breast Cancer Surgery: the Role of Post-operative Physical Therapy Intervention
A study testing PHYSICAL THERAPY in people with Breast Neoplasms, run by Assuta Medical Center at 1 site in Israel.
Trial summary
Surgical treatments can cause late effects influencing activity of daily living, physical activity, and overall health. Late effects include persistent pain reported by 30 - 50% of women that underwent breast operations, restrictions of arm and shoulder movement were reported in 35% of patients, lymphedema in 15 - 25%… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- PHYSICAL THERAPY
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jul 2018to 1 Sep 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women
- Age 18-65.
- Diagnosed with breast cancer, undergoing breast surgery,
- Functional independence prior to the operation.
- Ability to communicate in Hebrew.
Who cannot join
- Cognitive disorders, patients unable to sign the consent form.
- Back and spinal morbidity.
- Fibromyalgia or chronic pain disorders.
- Neurological disorders.
- Renal failure with the need for dialysis.
- Lymphedema prior to surgery.
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- History of breast surgery.
- Shoulder surgery or shoulder injuries with limited ROM.
- Ischemic heart disease, heart failure and radical heart insufficiency.
- Radical mastectomy, LD and DEIP reconstruction, exchange breast prosthesis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Upper Limb Function After Breast Cancer Surgery: the Role of Post-operative Physical Therapy Intervention- Randomized Control Trial
Surgical treatments can cause late effects influencing activity of daily living, physical activity, and overall health. Late effects include persistent pain reported by 30 - 50% of women that underwent breast operations, restrictions of arm and shoulder movement were reported in 35% of patients, lymphedema in 15 - 25% of women who undergo axillary lymph node dissection and in about 6% of women who undergo sentinel lymph node biopsy. Lymphedema results in physical impairments including compromised function, diminished strength, fatigue, and pain in the affected arm . The axillary web syndrome is a self-limiting and frequently overlooked cause of significant morbidity in the early postoperative period after breast cancer, which is characterized by axillary pain that runs down the medial arm, limited shoulder range of motion (ROM) .
Physiotherapy and exercise in the postoperative period can result in a significant improvement in shoulder ROM in women treated for breast cancer, Additionally, exercises are an effective intervention to improve quality of life, cardiorespiratory fitness, physical functioning and fatigue in breast cancer patients. However, in the postoperative period consideration should be given to the early implementation of exercises because of the potential for seroma and increases in wound drainage volume and duration.
There is limited evidence on the influence of postoperative physiotherapy intervention, and instruction program on upper limb range of motion and return to physical activity divided by the type of surgery and regarding complications.
Read the detailed description
Aim The aim of this study is to evaluate the influence of early postoperative physical therapy program on upper-limb function and returning to physical activity in the first 6 months following surgery.
Hypotheses
- Early physical activity performed post-operative will improve ROM and therefore, will help women after breast surgeries to return faster to their routine physical activity and by that promote physical health.
- Early postoperative physical therapy is safe when the program for is tailored to the type of surgery.
Methods
Study design Parallel group prospective randomized controlled clinical trial. Two surgical department's including general surgery department and genecology department in Assuta hospital, Tel Aviv, Israel
Sample All women undergoing breast cancer surgeries in Assuta hospital between 02.01.2018 and till 07.01.2019 will be randomized into two groups: Group A (intervention group) will be instructed first day post-operative to exercise program; Group B (control group) without intervention.
- Conditions
- Breast Neoplasms
- Being tested
- PHYSICAL THERAPY
- Keywords
- Breast surgery, Physiotherapy, Breast Cancer, Shoulder pain, Shoulder motion
- Medical subject headings
- Breast Neoplasms, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PHYSICAL THERAPYOther
EXERCISES AND EDUCATION TO FOLLOWING AFTER DISCHARGE PHYSICAL TREATMENT
| Study group | Role | What they receive |
|---|---|---|
| Breast surgery and exercise | Active comparator | Patient that underwent breast surgery only without other intervention with exercise of the upper limb and instruction to continue after discharge. Receives: Other: PHYSICAL THERAPY |
| Breast surgery and no exercise | Active comparator | Patient after breast surgery alone are discharged without exercise and instructions. Receives: Other: PHYSICAL THERAPY |
| Breast, axilar surgery with exercise | Active comparator | Patients that underwent surgery of the breast and axilar lymph node surgery with exercise of the upper limb and instruction to continue after discharge. Receives: Other: PHYSICAL THERAPY |
| Breast, axillar surgery without exercise | Active comparator | The patients that underwent surgery of the breast and axilar nodes samples or dissection are discharged without exercise and instructions. Receives: Other: PHYSICAL THERAPY |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder pain
The intensity of pain and chronological modification will be monitored
Measured: 6 mnth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2018
- Study start1 Jul 2018
- Primary completion1 Jul 2019
- Study completion1 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- RCT intervention and not intervention
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assuta Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sergio Gabriel Susmallian, Assuta Medical Center
- Investigators
- Sergio G Susmallian, MD, Study director, Assuta Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03389204
- Sponsor's protocol ID
- AMC2020-17
- Status last verified
- Jan 2021
- First submitted
- 26 Dec 2017
- Last updated
- 26 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The patient will be evaluated after discharge by meetings or though video calls/
Publications
Klein I, Kalichman L, Chen N, Susmallian S. A comprehensive approach to risk factors for upper arm morbidities following breast cancer treatment: a prospective study. BMC Cancer. 2021 Nov 20;21(1):1251. doi: 10.1186/s12885-021-08891-5.
PubMed 34800988
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Upper Limb Function After Breast Cancer Surgery: the Role of Post-operative Physical Therapy Intervention- Randomized Control Trial
- ClinicalTrials.gov ID
- NCT03389204
- Acronym / sponsor ID
- AMC2020-17
- Conditions
- Breast Neoplasms
- Keywords
- Breast surgery, Physiotherapy, Breast Cancer, Shoulder pain, Shoulder motion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Assuta Medical CenterUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 3 Jan 2018 (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.
Surgical treatments can cause late effects influencing activity of daily living, physical activity, and overall health. Late effects include persistent pain reported by 30 - 50% of women that underwent breast operations, restrictions of arm and shoulder movement were reported in 35% of patients, lymphedema in 15 - 25% of women who undergo axillary lymph node dissection and in about 6% of women who undergo sentinel lymph node biopsy. Lymphedema results in physical impairments including compromised function, diminished strength, fatigue, and pain in the affected arm . The axillary web syndrome is a self-limiting and frequently overlooked cause of significant morbidity in the early postoperative period after breast cancer, which is characterized by axillary pain that runs down the medial arm, limited shoulder range of motion (ROM) .
Physiotherapy and exercise in the postoperative period can result in a significant improvement in shoulder ROM in women treated for breast cancer, Additionally, exercises are an effective intervention to improve quality of life, cardiorespiratory fitness, physical functioning and fatigue in breast cancer patients. However, in the postoperative period consideration should be given to the early implementation of exercises because of the potential for seroma and increases in wound drainage volume and duration.
There is limited evidence on the influence of postoperative physiotherapy intervention, and instruction program on upper limb range of motion and return to physical activity divided by the type of surgery and regarding complications.
Detailed description
Aim The aim of this study is to evaluate the influence of early postoperative physical therapy program on upper-limb function and returning to physical activity in the first 6 months following surgery.
Hypotheses
- Early physical activity performed post-operative will improve ROM and therefore, will help women after breast surgeries to return faster to their routine physical activity and by that promote physical health.
- Early postoperative physical therapy is safe when the program for is tailored to the type of surgery.
Methods
Study design Parallel group prospective randomized controlled clinical trial. Two surgical department's including general surgery department and genecology department in Assuta hospital, Tel Aviv, Israel
Sample All women undergoing breast cancer surgeries in Assuta hospital between 02.01.2018 and till 07.01.2019 will be randomized into two groups: Group A (intervention group) will be instructed first day post-operative to exercise program; Group B (control group) without intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- RCT intervention and not intervention
| Arm | Type | Receives |
|---|---|---|
| Breast surgery and exercise | Active comparator | Other: PHYSICAL THERAPYPatient that underwent breast surgery only without other intervention with exercise of the upper limb and instruction to continue after discharge. |
| Breast surgery and no exercise | Active comparator | Other: PHYSICAL THERAPYPatient after breast surgery alone are discharged without exercise and instructions. |
| Breast, axilar surgery with exercise | Active comparator | Other: PHYSICAL THERAPYPatients that underwent surgery of the breast and axilar lymph node surgery with exercise of the upper limb and instruction to continue after discharge. |
| Breast, axillar surgery without exercise | Active comparator | Other: PHYSICAL THERAPYThe patients that underwent surgery of the breast and axilar nodes samples or dissection are discharged without exercise and instructions. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women
- Age 18-65.
- Diagnosed with breast cancer, undergoing breast surgery,
- Functional independence prior to the operation.
- Ability to communicate in Hebrew.
Key exclusion criteria (10 listed)
- Cognitive disorders, patients unable to sign the consent form.
- Back and spinal morbidity.
- Fibromyalgia or chronic pain disorders.
- Neurological disorders.
- Renal failure with the need for dialysis.
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 |
|---|---|---|
| PHYSICAL THERAPYEXERCISES AND EDUCATION TO FOLLOWING AFTER DISCHARGE PHYSICAL TREATMENT | Other | Breast surgery and exercise, Breast surgery and no exercise, Breast, axilar surgery with exercise, Breast, axillar surgery without exercise |
Primary outcome
Shoulder pain
Time frame: 6 mnth
The intensity of pain and chronological modification will be monitored
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 26 Jan 2021.
- Derived from this study: PubMed 34800988Klein I, Kalichman L, Chen N, Susmallian S. A comprehensive approach to risk factors for upper arm morbidities following breast cancer treatment: a prospective study. BMC Cancer. 2021 Nov 20;21(1):1251. doi: 10.1186/s12885-021-08891-5.
- Individual participant dataSharing planned: Yes. The patient will be evaluated after discharge by meetings or though video calls/
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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.
Sergio G Susmallian, MD study director
Assuta Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PHYSICAL THERAPY in people with Breast Neoplasms, run by Assuta Medical Center at 1 site in Israel.
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 10 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 26 Jan 2021. 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 Israel. 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?
Shoulder pain (time frame: 6 mnth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03389204, which also lists 1 linked publication.
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 26 Jan 2021.