Lymphedema Prevention After Lymph Node Emptying

NCT04785599 | Completed

• 1 other identifier: IIBSP-EPC-2011-87
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Lymphedema; Breast Cancer; Prevention; Rehabilitation

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Other Outcomes (3)

• Measure of arms volume

  All patients were evaluated at 6 months from beginning

• Measure of arms volume

  All patients were evaluated at 12 months from beginning

• Measure of arms volume

  All patients were evaluated at 24 months from beginning

Study Arms (2)

Group EC1: Exercices, informative talk

EXPERIMENTAL

Group EC1 carried out the conventional prevention program consisting of an informative talk and an exercise program

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

Behavioral: Exercices; Behavioral: Informative talk; Device: Compression garment

Interventions

Exercices BEHAVIORAL

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 EC1: Exercices, informative talk; Group ECCP2: Exercices, informative talk, compression garment

Informative talk BEHAVIORAL

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

Group EC1: Exercices, informative talk; Group ECCP2: Exercices, informative talk, compression garment

Compression garment DEVICE

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.

Group ECCP2: Exercices, informative talk, compression garment

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: lead

Related 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.

  PMID: 30498426 BACKGROUND

• 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.

  PMID: 19499762 BACKGROUND

• 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.

  PMID: 21731515 BACKGROUND

• Castro-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.

  PMID: 21145085 BACKGROUND

• 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.

  PMID: 25324019 BACKGROUND

• De Miguel, C., Alonso, B., Hernandez, M., Crespo, M.P., Gil, M.S., 2010. Treatment with compression garments. Rehabilitation, 44 (51), 58-62.

  BACKGROUND

• 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.

  PMID: 23540561 BACKGROUND

• Gonzalez-Sanchez, J., and Sánchez- Mata, F., 2010. Quality of life, rating scales and preventive measures in lymphedema. Rehabilitation 44 (S1), 44-48.

  BACKGROUND

• 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.

  PMID: 19204604 BACKGROUND

• 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.

  PMID: 22002586 BACKGROUND

• 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.

  PMID: 21079093 BACKGROUND

• 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.

  PMID: 30339481 BACKGROUND

• Sagen 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.

  PMID: 19863217 BACKGROUND

• 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

  BACKGROUND

• SERMEF. 2012. Applications. Lymphedema calculator for upper limb (Consulted on January 10, 2012). Available at: http://www.sermef.es/index.php.

  BACKGROUND

• 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.

  PMID: 26440777 BACKGROUND

• 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.

  PMID: 22488693 BACKGROUND

• 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.

  PMID: 18428212 BACKGROUND

• 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.

  PMID: 31229204 BACKGROUND

MeSH Terms

Conditions

Lymphedema; Breast Neoplasms

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Maria José Nadal Castells, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2021
• First Posted: March 8, 2021
• Study Start: October 3, 2011
• Primary Completion: October 3, 2011
• Study Completion: April 13, 2015
• Last Updated: March 8, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Supporting information is already available
• Access Criteria: Free access