LymphedemaNCT04785599
Lymphedema Prevention After Lymph Node Emptying
A study testing Exercices, Informative talk and Compression garment in people with Lymphedema and Breast Cancer, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau.
Trial summary
ABSTRACT Object: The impact of morbidity and the deterioration in health-related quality of life for patients with lymphedema after axillary lymph node dissection for breast cancer justify the implementation of prevention programs to decrease the incidence of this chronic condition. Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Lymphedema, Breast Cancer, Prevention
- What is being tested?
- Exercices, Informative talk and Compression garment
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 3 Oct 2011to 13 Apr 2015
- 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 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having undergone a lymph node dissection as part of treatment for primary breast neoplasm
- Acceptance of the study conditions and signing of the informed consent
Who cannot join
- Tumour recurrences
- Metastatic cancer
- Open wounds or loss of skin integrity
- Dependency or deterioration of higher functions
- Arterial insufficiency and deep vein thrombosis
- Acute heart failure
- Severe peripheral neuropathy
- Lymphedema
About this study
Official title: Effectiveness of Lymphedema Prevention Programs After Lymph Node Emptying in Breast Cancer: A Randomized Clinical Trial
ABSTRACT Object: The impact of morbidity and the deterioration in health-related quality of life for patients with lymphedema after axillary lymph node dissection for breast cancer justify the implementation of prevention programs to decrease the incidence of this chronic condition. The aim was to compare the effectiveness of an experimental prevention program with that of our conventional prevention program.
Methods: Clinical randomized trial in two parallel groups over a two-year period.
Key words: lymphedema, breast cancer, prevention, rehabilitation
Read the detailed description
This was a single-centre, open-label, controlled, randomized clinical trial. Patients were recruited from the Breast Pathology Unit at Hospital de la Santa Creu i Sant Pau (HSCSP), a tertiary referral hospital in Barcelona between March 2011 and April 2013. The inclusion criteria were as follows:
- Patients between 18 and 85 years
- Having undergone a lymph node dissection as part of treatment for primary breast neoplasm
- Acceptance of the study conditions and signing of the informed consent
Exclusion criteria were:
- tumour recurrences
- metastatic cancer
- open wounds or loss of skin integrity
- dependency or deterioration of higher functions
- arterial insufficiency and deep vein thrombosis
- acute heart failure
- severe peripheral neuropathy
- lymphedema Patients included in the study were randomized to one of two groups. Group 1(G1) carried out the conventional prevention program consisting of an informative talk and an exercise program. Group 2(G2) carried out the same program but with the addition of a prophylactic compression garment.
The program common to both groups consisted of:
- An informative talk: Patients attended a one-hour long talk about lymphedema. The topics covered were a description of the condition, the risks, and preventive measures to include in their daily life. The recommended measures were those from the general consensus of the International Lymphedema Society, the Spanish Rehabilitation Society and The National Breast and Ovarian Cancer Center (J.González-Sánchez y Sánchez- Mata F 2010) (See tables 1 and 2).
- An exercise program. Seven days after lymph node removal, participants began this program at the physiotherapy department. They attended two weekly sessions of 60 minutes each. The sessions at the centre continued for 12 weeks. The program consisted of aerobic exercise, in combination with resistance and stretching exercises.
Group 2 (experimental) was also prescribed:
- A flat knit compression garment (CG), class 1. Participants were recommended to wear this CG for an average of 8 hours during the daytime for the first 3 months after surgery, and to remove it at night. From the fourth month onwards, use of the garment was reduced to 2 hours a day, coinciding with exercises and physical activity.
The study was evaluated and authorized by the Ethics Committee at Hospital de la Santa Creu i Sant Pau (HSCSP), code IIBS-EPC-2011-87. All patients signed the written informed consent form.
Evaluations All patients were evaluated at the start of the study, at the end of the exercise prevention program, at 6 months, and at one and two years.
In all the evaluations, we measured the volume of the upper extremities following the lymphedema calculation formula based on the truncated cone, validated and published by the Spanish Society of Physical Medicine and Rehabilitation (SERMEF).
Lymphedema was defined as a difference of more than 200 ml in volume between the upper extremities, or as a difference of 10% in volume between the two upper limbs (SERMEF 2012).
We recorded all the parameters of the history and general clinical examination, TNM stage, performed treatments, number of resected nodes and complications. Compliance with all the components of each program was monitored. Data regarding presence at the talk and at the exercise program sessions at the centre were recorded by calendar. Home compliance was monitored through personal interviews at 6 months, 1 year and 2 years.
- Conditions
- Lymphedema, Breast Cancer, Prevention, Rehabilitation
- Being tested
- Exercices, Informative talk, Compression garment
- Medical subject headings
- Lymphedema, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExercicesBehavioural
An exercise program. Seven days after lymph node removal, participants began this program at the physiotherapy department. They attended two weekly sessions of 60 minutes each. The sessions at the centre continued for 12 weeks. The program consisted of aerobic exercise, in combination with resistance and stretching exercises.
Informative talkBehavioural
An informative talk: Patients attended a one-hour long talk about lymphedema. The topics covered were a description of the condition, the risks, and preventive measures to include in their daily life. The recommended measures were those from the general consensus of the International Lymphedema Society, the Spanish Rehabilitation Society and The National Breast and Ovarian Cancer Center
Compression garmentDevice
Wearing a flat knit compression garment (CG), class 1. Participants were recommended to wear this CG for an average of 8 hours during the daytime for the first 3 months after surgery, and to remove it at night.
From the fourth month onwards, use of the garment was reduced to 2 hours a day, coinciding with exercises and physical activity.
| Study group | Role | What they receive |
|---|---|---|
| Group EC1: Exercices, informative talk | Experimental | Group EC1 carried out the conventional prevention program consisting of an informative talk and an exercise program Receives: Behavioral: Exercices; Behavioral: Informative talk |
| Group ECCP2: Exercices, informative talk, compression garment | Experimental | Group ECCP2 carried out the same program but with the addition of a prophylactic compression garment Receives: Behavioral: Exercices; Behavioral: Informative talk; Device: Compression garment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of arms volume
Lymphedema was defined as a difference of more than 200 ml in volume between the upper extremities, or as a difference of 10% in volume between the two upper limbs (SERMEF 2012).
Measured: All patients were evaluated at the start of the study
Measure of arms volume
Lymphedema was defined as a difference of more than 200 ml in volume between the upper extremities, or as a difference of 10% in volume between the two upper limbs
Measured: All patients were evaluated at 3 months from beginning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2021
- Study start3 Oct 2011
- Primary completion3 Oct 2011
- Study completion13 Apr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for LymphedemaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria José Nadal Castells, PhD, Principal investigator, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04785599
- Sponsor's protocol ID
- IIBSP-EPC-2011-87
- Status last verified
- Mar 2021
- First submitted
- 26 Jan 2021
- Last updated
- 8 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We recorded all the parameters of the history and general clinical examination, TNM stage, performed treatments, number of resected nodes and complications. Compliance with all the components of each program was monitored. Data regarding presence at the talk and at the exercise program sessions at the centre were recorded by calendar. Home compliance was monitored through personal interviews at 6 months, 1 year and 2 years.
Publications
Baumann FT, Reike A, Hallek M, Wiskemann J, Reimer V. Does Exercise Have a Preventive Effect on Secondary Lymphedema in Breast Cancer Patients Following Local Treatment? - A Systematic Review. Breast Care (Basel). 2018 Oct;13(5):380-385. doi: 10.1159/000487428. Epub 2018 May 3.
PubMed 30498426Boccardo FM, Ansaldi F, Bellini C, Accogli S, Taddei G, Murdaca G, Campisi CC, Villa G, Icardi G, Durando P, Puppo F, Campisi C. Prospective evaluation of a prevention protocol for lymphedema following surgery for breast cancer. Lymphology. 2009 Mar;42(1):1-9.
PubMed 19499762Cavanaugh KM. Effects of early exercise on the development of lymphedema in patients with breast cancer treated with axillary lymph node dissection. J Oncol Pract. 2011 Mar;7(2):89-93. doi: 10.1200/JOP.2010.000136.
PubMed 21731515Castro-Sanchez AM, Moreno-Lorenzo C, Mataran-Penarrocha GA, Aguilar-Ferrandiz ME, Almagro-Cespedes I, Anaya-Ojeda J. [Preventing lymphoedema after breast cancer surgery by elastic restraint orthotic and manual lymphatic drainage: a randomized clinical trial]. Med Clin (Barc). 2011 Jul 23;137(5):204-7. doi: 10.1016/j.medcli.2010.09.020. Epub 2010 Dec 8. Spanish.
PubMed 21145085Cheema BS, Kilbreath SL, Fahey PP, Delaney GP, Atlantis E. Safety and efficacy of progressive resistance training in breast cancer: a systematic review and meta-analysis. Breast Cancer Res Treat. 2014 Nov;148(2):249-68. doi: 10.1007/s10549-014-3162-9. Epub 2014 Oct 17.
PubMed 25324019De Miguel, C., Alonso, B., Hernandez, M., Crespo, M.P., Gil, M.S., 2010. Treatment with compression garments. Rehabilitation, 44 (51), 58-62.
DiSipio T, Rye S, Newman B, Hayes S. Incidence of unilateral arm lymphoedema after breast cancer: a systematic review and meta-analysis. Lancet Oncol. 2013 May;14(6):500-15. doi: 10.1016/S1470-2045(13)70076-7. Epub 2013 Mar 27.
PubMed 23540561Gonzalez-Sanchez, J., and Sánchez- Mata, F., 2010. Quality of life, rating scales and preventive measures in lymphedema. Rehabilitation 44 (S1), 44-48.
Hayes SC, Reul-Hirche H, Turner J. Exercise and secondary lymphedema: safety, potential benefits, and research issues. Med Sci Sports Exerc. 2009 Mar;41(3):483-9. doi: 10.1249/MSS.0b013e31818b98fb.
PubMed 19204604Kwan ML, Cohn JC, Armer JM, Stewart BR, Cormier JN. Exercise in patients with lymphedema: a systematic review of the contemporary literature. J Cancer Surviv. 2011 Dec;5(4):320-36. doi: 10.1007/s11764-011-0203-9. Epub 2011 Oct 16.
PubMed 22002586Kwan ML, Darbinian J, Schmitz KH, Citron R, Partee P, Kutner SE, Kushi LH. Risk factors for lymphedema in a prospective breast cancer survivorship study: the Pathways Study. Arch Surg. 2010 Nov;145(11):1055-63. doi: 10.1001/archsurg.2010.231.
PubMed 21079093Ochalek K, Partsch H, Gradalski T, Szygula Z. Do Compression Sleeves Reduce the Incidence of Arm Lymphedema and Improve Quality of Life? Two-Year Results from a Prospective Randomized Trial in Breast Cancer Survivors. Lymphat Res Biol. 2019 Feb;17(1):70-77. doi: 10.1089/lrb.2018.0006. Epub 2018 Oct 19.
PubMed 30339481Sagen A, Karesen R, Risberg MA. Physical activity for the affected limb and arm lymphedema after breast cancer surgery. A prospective, randomized controlled trial with two years follow-up. Acta Oncol. 2009;48(8):1102-10. doi: 10.3109/02841860903061683.
PubMed 19863217Sander, A.P., 2008. A safe and effective upper extremity resistive exercise program for woman post breast cancer treatment. Rehabilitation Oncology. 26(3), 3-10
SERMEF. 2012. Applications. Lymphedema calculator for upper limb (Consulted on January 10, 2012). Available at: http://www.sermef.es/index.php.
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Lymphedema Prevention Programs After Lymph Node Emptying in Breast Cancer: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04785599
- Acronym / sponsor ID
- IIBSP-EPC-2011-87
- Conditions
- Lymphedema, Breast Cancer, Prevention, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- 3 Oct 2011 (actual)
- Primary completion
- 3 Oct 2011 (actual)
- Study completion
- 13 Apr 2015 (actual)
- First posted
- 8 Mar 2021 (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.
ABSTRACT Object: The impact of morbidity and the deterioration in health-related quality of life for patients with lymphedema after axillary lymph node dissection for breast cancer justify the implementation of prevention programs to decrease the incidence of this chronic condition. The aim was to compare the effectiveness of an experimental prevention program with that of our conventional prevention program.
Methods: Clinical randomized trial in two parallel groups over a two-year period.
Key words: lymphedema, breast cancer, prevention, rehabilitation
Detailed description
This was a single-centre, open-label, controlled, randomized clinical trial. Patients were recruited from the Breast Pathology Unit at Hospital de la Santa Creu i Sant Pau (HSCSP), a tertiary referral hospital in Barcelona between March 2011 and April 2013. The inclusion criteria were as follows:
- Patients between 18 and 85 years
- Having undergone a lymph node dissection as part of treatment for primary breast neoplasm
- Acceptance of the study conditions and signing of the informed consent
Exclusion criteria were:
- tumour recurrences
- metastatic cancer
- open wounds or loss of skin integrity
- dependency or deterioration of higher functions
- arterial insufficiency and deep vein thrombosis
- acute heart failure
- severe peripheral neuropathy
- lymphedema Patients included in the study were randomized to one of two groups. Group 1(G1) carried out the conventional prevention program consisting of an informative talk and an exercise program. Group 2(G2) carried out the same program but with the addition of a prophylactic compression garment.
The program common to both groups consisted of:
- An informative talk: Patients attended a one-hour long talk about lymphedema. The topics covered were a description of the condition, the risks, and preventive measures to include in their daily life. The recommended measures were those from the general consensus of the International Lymphedema Society, the Spanish Rehabilitation Society and The National Breast and Ovarian Cancer Center (J.González-Sánchez y Sánchez- Mata F 2010) (See tables 1 and 2).
- An exercise program. Seven days after lymph node removal, participants began this program at the physiotherapy department. They attended two weekly sessions of 60 minutes each. The sessions at the centre continued for 12 weeks. The program consisted of aerobic exercise, in combination with resistance and stretching exercises.
Group 2 (experimental) was also prescribed:
- A flat knit compression garment (CG), class 1. Participants were recommended to wear this CG for an average of 8 hours during the daytime for the first 3 months after surgery, and to remove it at night. From the fourth month onwards, use of the garment was reduced to 2 hours a day, coinciding with exercises and physical activity.
The study was evaluated and authorized by the Ethics Committee at Hospital de la Santa Creu i Sant Pau (HSCSP), code IIBS-EPC-2011-87. All patients signed the written informed consent form.
Evaluations All patients were evaluated at the start of the study, at the end of the exercise prevention program, at 6 months, and at one and two years.
In all the evaluations, we measured the volume of the upper extremities following the lymphedema calculation formula based on the truncated cone, validated and published by the Spanish Society of Physical Medicine and Rehabilitation (SERMEF).
Lymphedema was defined as a difference of more than 200 ml in volume between the upper extremities, or as a difference of 10% in volume between the two upper limbs (SERMEF 2012).
We recorded all the parameters of the history and general clinical examination, TNM stage, performed treatments, number of resected nodes and complications. Compliance with all the components of each program was monitored. Data regarding presence at the talk and at the exercise program sessions at the centre were recorded by calendar. Home compliance was monitored through personal interviews at 6 months, 1 year and 2 years.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group EC1: Exercices, informative talk | Experimental | Behavioral: Exercices, Behavioral: Informative talkGroup EC1 carried out the conventional prevention program consisting of an informative talk and an exercise program |
| Group ECCP2: Exercices, informative talk, compression garment | Experimental | Behavioral: Exercices, Behavioral: Informative talk, Device: Compression garmentGroup ECCP2 carried out the same program but with the addition of a prophylactic compression garment |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Having undergone a lymph node dissection as part of treatment for primary breast neoplasm
- Acceptance of the study conditions and signing of the informed consent
Key exclusion criteria (8 listed)
- Tumour recurrences
- Metastatic cancer
- Open wounds or loss of skin integrity
- Dependency or deterioration of higher functions
- Arterial insufficiency and deep vein thrombosis
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 |
|---|---|---|
| ExercicesAn exercise program. Seven days after lymph node removal, participants began this program at the physiotherapy department. They attended two weekly sessions of 60 minutes each. The sessions at the centre continued for 12 weeks. The program consisted of aerobic exercise, in combination with resistance and stretching exercises. | Behavioural | Group EC1: Exercices, informative talk, Group ECCP2: Exercices, informative talk, compression garment |
| Informative talkAn informative talk: Patients attended a one-hour long talk about lymphedema. The topics covered were a description of the condition, the risks, and preventive measures to include in their daily life. The recommended measures were those from the general consensus of the International Lymphedema Society, the Spanish Rehabilitation Society and The National Breast and Ovarian Cancer Center | Behavioural | Group EC1: Exercices, informative talk, Group ECCP2: Exercices, informative talk, compression garment |
| Compression garmentWearing a flat knit compression garment (CG), class 1. Participants were recommended to wear this CG for an average of 8 hours during the daytime for the first 3 months after surgery, and to remove it at night. From the fourth month onwards, use of the garment was reduced to 2 hours a day, coinciding with exercises and physical activity. | Device | Group ECCP2: Exercices, informative talk, compression garment |
Primary outcome
Measure of arms volume
Time frame: All patients were evaluated at the start of the study
Lymphedema was defined as a difference of more than 200 ml in volume between the upper extremities, or as a difference of 10% in volume between the two upper limbs (SERMEF 2012).
Measure of arms volume
Time frame: All patients were evaluated at 3 months from beginning
Lymphedema was defined as a difference of more than 200 ml in volume between the upper extremities, or as a difference of 10% in volume between the two upper limbs
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 8 Mar 2021.
- Background: PubMed 30498426Baumann FT, Reike A, Hallek M, Wiskemann J, Reimer V. Does Exercise Have a Preventive Effect on Secondary Lymphedema in Breast Cancer Patients Following Local Treatment? - A Systematic Review. Breast Care (Basel). 2018 Oct;13(5):380-385. doi: 10.1159/000487428. Epub 2018 May 3.
- Background: PubMed 19499762Boccardo FM, Ansaldi F, Bellini C, Accogli S, Taddei G, Murdaca G, Campisi CC, Villa G, Icardi G, Durando P, Puppo F, Campisi C. Prospective evaluation of a prevention protocol for lymphedema following surgery for breast cancer. Lymphology. 2009 Mar;42(1):1-9.
- Background: PubMed 21731515Cavanaugh KM. Effects of early exercise on the development of lymphedema in patients with breast cancer treated with axillary lymph node dissection. J Oncol Pract. 2011 Mar;7(2):89-93. doi: 10.1200/JOP.2010.000136.
- Background: PubMed 21145085Castro-Sanchez AM, Moreno-Lorenzo C, Mataran-Penarrocha GA, Aguilar-Ferrandiz ME, Almagro-Cespedes I, Anaya-Ojeda J. [Preventing lymphoedema after breast cancer surgery by elastic restraint orthotic and manual lymphatic drainage: a randomized clinical trial]. Med Clin (Barc). 2011 Jul 23;137(5):204-7. doi: 10.1016/j.medcli.2010.09.020. Epub 2010 Dec 8. Spanish.
- Background: PubMed 25324019Cheema BS, Kilbreath SL, Fahey PP, Delaney GP, Atlantis E. Safety and efficacy of progressive resistance training in breast cancer: a systematic review and meta-analysis. Breast Cancer Res Treat. 2014 Nov;148(2):249-68. doi: 10.1007/s10549-014-3162-9. Epub 2014 Oct 17.
- BackgroundDe Miguel, C., Alonso, B., Hernandez, M., Crespo, M.P., Gil, M.S., 2010. Treatment with compression garments. Rehabilitation, 44 (51), 58-62.
- Background: PubMed 23540561DiSipio T, Rye S, Newman B, Hayes S. Incidence of unilateral arm lymphoedema after breast cancer: a systematic review and meta-analysis. Lancet Oncol. 2013 May;14(6):500-15. doi: 10.1016/S1470-2045(13)70076-7. Epub 2013 Mar 27.
- BackgroundGonzalez-Sanchez, J., and Sánchez- Mata, F., 2010. Quality of life, rating scales and preventive measures in lymphedema. Rehabilitation 44 (S1), 44-48.
- Background: PubMed 19204604Hayes SC, Reul-Hirche H, Turner J. Exercise and secondary lymphedema: safety, potential benefits, and research issues. Med Sci Sports Exerc. 2009 Mar;41(3):483-9. doi: 10.1249/MSS.0b013e31818b98fb.
- Background: PubMed 22002586Kwan ML, Cohn JC, Armer JM, Stewart BR, Cormier JN. Exercise in patients with lymphedema: a systematic review of the contemporary literature. J Cancer Surviv. 2011 Dec;5(4):320-36. doi: 10.1007/s11764-011-0203-9. Epub 2011 Oct 16.
- Background: PubMed 21079093Kwan ML, Darbinian J, Schmitz KH, Citron R, Partee P, Kutner SE, Kushi LH. Risk factors for lymphedema in a prospective breast cancer survivorship study: the Pathways Study. Arch Surg. 2010 Nov;145(11):1055-63. doi: 10.1001/archsurg.2010.231.
- Background: PubMed 30339481Ochalek K, Partsch H, Gradalski T, Szygula Z. Do Compression Sleeves Reduce the Incidence of Arm Lymphedema and Improve Quality of Life? Two-Year Results from a Prospective Randomized Trial in Breast Cancer Survivors. Lymphat Res Biol. 2019 Feb;17(1):70-77. doi: 10.1089/lrb.2018.0006. Epub 2018 Oct 19.
- Individual participant dataSharing planned: Yes. We recorded all the parameters of the history and general clinical examination, TNM stage, performed treatments, number of resected nodes and complications. Compliance with all the components of each program was monitored. Data regarding presence at the talk and at the exercise program sessions at the centre were recorded by calendar. Home compliance was monitored through personal interviews at 6 months, 1 year and 2 years.
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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.
Maria José Nadal Castells, PhD principal investigator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Questions about this trial
What is this clinical trial studying?
A study testing Exercices, Informative talk and Compression garment in people with Lymphedema and Breast Cancer, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau.
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 2 inclusion and 8 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 8 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Measure of arms volume (time frame: All patients were evaluated at the start of the study). The study lists 2 primary outcomes in all. 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 NCT04785599, which also lists 19 linked publications.
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 8 Mar 2021.