Effects of Physiotherapy in the Treatment of Lymphedema After Breast Cancer

NCT05037708 | Completed

• 1 other identifier: Fisioterapia en Linfedema
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

Lymphedema related to breast cancer is one of the main complications after breast cancer treatment. Manual lymphatic drainage appears as a technique which could be applied in the treatment of lymphedema along with other techniques. The aim of this study is to analyze the effects of a physiotherapy program based on manual lymphatic drainage on the treatment of lymphedema after breast cancer, during the stabilization or maintenance phase of complex decongestant therapy. Therefore, a randomized, blinded, crossover clinical trial is suggested to assess the effect of an intensive physiotherapy intervention on the treatment of lymphedema in its maintenance phase, in comparison with a control group without physiotherapy treatment. The cytometry, displaced water volume, thickness of the lymphedema with ultrasound, dynamometry and sensation of heaviness, pain and tension of the upper limb will be evaluated.

Conditions

Lymphedema of Upper Limb

Keywords

Lymphedema of Upper Limb; Breast Neoplasms; Physical Therapy Modalities

Outcome Measures

Primary Outcomes (12)

• circometry

  measurement of upper limb perimeters

  1 day

• circometry

  measurement of upper limb perimeters

  1 month

• circometry

  measurement of upper limb perimeters

  3 month

• circometry

  measurement of upper limb perimeters

  4 month

• Volumetry by water displacement

  weight of water extravasated when introducing the upper limb into a container with water

  1 day

• Volumetry by water displacement

  weight of water extravasated when introducing the upper limb into a container with water

  1 month

• Volumetry by water displacement

  weight of water extravasated when introducing the upper limb into a container with water

  3 month

• Volumetry by water displacement

  weight of water extravasated when introducing the upper limb into a container with water

  4 month

• Measurement of edema thickness by ultrasound

  measurement of subcutaneous tissue thickness

  1 day

• Measurement of edema thickness by ultrasound

  measurement of subcutaneous tissue thickness

  1 month

• Measurement of edema thickness by ultrasound

  measurement of subcutaneous tissue thickness

  3 month

• Measurement of edema thickness by ultrasound

  measurement of subcutaneous tissue thickness

  4 month

Secondary Outcomes (16)

• Assessment of the sensation of heaviness

  1 day

• Assessment of the sensation of heaviness

  1 month

• Assessment of the sensation of heaviness

  3 month

• Assessment of the sensation of heaviness

  4 month

• Assessment of the sensation of pain

  1 day

Study Arms (2)

Group 1

EXPERIMENTAL

Group 1 receives treatment A for 4 weeks. Afterwards, a period of washing or bleaching should be allowed in order to be sure that the effects of the intervention have disappeared. This period will last 2 months during which the usual treatment for LGA patients will be carried out, which consists of 2 monthly physiotherapy sessions, in this way it is intended that the subjects are in the initial state (as before the start of the first intervention). After this washout period, treatment B was applied to group 1.

Procedure: Manual lymphatic drainage

Group 2

ACTIVE COMPARATOR

Group 2 receives treatment B for 4 weeks. Afterwards, a period of washing or bleaching should be allowed in order to be sure that the effects of the intervention have disappeared. This period will last 2 months during which the usual treatment for LGA patients will be carried out, which consists of 2 monthly physiotherapy sessions, in this way it is intended that the subjects are in the initial state (as before the start of the first intervention). After this washout period, treatment A was applied to group 2 .

Procedure: Manual lymphatic drainage

Interventions

Manual lymphatic drainage PROCEDURE

Subjects are randomly assigned to group 1. Group 1 receives treatment A\* for 4 weeks. Afterwards, a period of washing or bleaching should be allowed in order to be sure that the effects of the intervention have disappeared. This period will last 2 months during which the usual treatment for LGA patients will be carried out, which consists of 2 monthly physiotherapy sessions, in this way it is intended that the subjects are in the initial state (as before the start of the first intervention). After this washout period, treatment B\*\* was applied to group 1 for 4 weeks. \*Treatment A consists of manual lymphatic drainage. \*\*Treatment B consists of no treatment

Group 1

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Women included in the lymphedema treatment maintenance program through the Galician Lymphedema Association
• Women with secondary unilateral lymphedema after breast cancer

You may not qualify if:

• Women undergoing chemotherapy or radiotherapy treatment.
• Severe systemic or neurological disease

Sponsors & Collaborators

• University of Vigo: lead
• Asociación Gallega de Linfedema: collaborator

Study Sites (1)

Faculty of Physiotherapy

Pontevedra, 36005, Spain

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Manual Lymphatic Drainage

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Massage; Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Drainage; Physical Therapy Modalities; Rehabilitation

Study Officials

• Eva M Lantarón_Caeiro, Dra

  Physiotherapy Group (FS1) - Faculty of Physiotherapy -University of Vigo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Therefore, a randomized, blinded, crossover clinical trial is suggested to assess the effect of an intensive physiotherapy intervention on the treatment of lymphedema in its maintenance phase, in comparison with a control group without physiotherapy treatment.

Study Record Dates

• First Submitted: July 19, 2021
• First Posted: September 8, 2021
• Study Start: March 1, 2022
• Primary Completion: July 1, 2022
• Study Completion: October 27, 2022
• Last Updated: April 6, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)