Lymphedema Prevention After Lymph Node Emptying

Breast Cancer Clinical Trial

Official title:

Effectiveness of Lymphedema Prevention Programs After Lymph Node Emptying in Breast Cancer: A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04785599
• Other study ID #: IIBSP-EPC-2011-87
• Status: Completed
• Phase: N/A
• Start date: October 3, 2011
• Est. completion date: April 13, 2015

Study information

• Verified date: March 2021
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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

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:

1. 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: April 13, 2015
• Est. primary completion date: October 3, 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• 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:

• 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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Lymphedema
• Prevention
• Rehabilitation

Intervention

Behavioral:
• Exercices
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 talk
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

Device:
• Compression garment
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

References & Publications (19)

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. Review. — View Citation

Boccardo 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. Erratum in: Lymphology. 2009 Sep;42(3):149. — View Citation

Castro-Sánchez AM, Moreno-Lorenzo C, Matarán-Peñarrocha GA, Aguilar-Ferrándiz ME, Almagro-Céspedes 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. — View Citation

Cavanaugh 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. — View Citation

Cheema 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. Review. — View Citation

De 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. Review. — View Citation

Gonzalez-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. — View Citation

Kwan 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. Review. — View Citation

Kwan 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. — View Citation

Ochalek 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. — View Citation

Sagen A, Kåresen 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. — View Citation

Sander, 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.

Singh B, Disipio T, Peake J, Hayes SC. Systematic Review and Meta-Analysis of the Effects of Exercise for Those With Cancer-Related Lymphedema. Arch Phys Med Rehabil. 2016 Feb;97(2):302-315.e13. doi: 10.1016/j.apmr.2015.09.012. Epub 2015 Oct 9. Review. — View Citation

Stout Gergich NL, Pfalzer LA, McGarvey C, Springer B, Gerber LH, Soballe P. Preoperative assessment enables the early diagnosis and successful treatment of lymphedema. Cancer. 2008 Jun 15;112(12):2809-19. doi: 10.1002/cncr.23494. — View Citation

Stout NL, Binkley JM, Schmitz KH, Andrews K, Hayes SC, Campbell KL, McNeely ML, Soballe PW, Berger AM, Cheville AL, Fabian C, Gerber LH, Harris SR, Johansson K, Pusic AL, Prosnitz RG, Smith RA. A prospective surveillance model for rehabilitation for women with breast cancer. Cancer. 2012 Apr 15;118(8 Suppl):2191-200. doi: 10.1002/cncr.27476. Review. — View Citation

Temur K, Kapucu S. The effectiveness of lymphedema self-management in the prevention of breast cancer-related lymphedema and quality of life: A randomized controlled trial. Eur J Oncol Nurs. 2019 Jun;40:22-35. doi: 10.1016/j.ejon.2019.02.006. Epub 2019 Feb 25. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	All patients were evaluated at 6 months from beginning
Other	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	All patients were evaluated at 12 months from beginning
Other	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	All patients were evaluated at 24 months from beginning
Primary	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).	All patients were evaluated at the start of the study
Primary	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	All patients were evaluated at 3 months from beginning