Supervised Resistance TRaining amONG Women at Risk of Breast Cancer Related Lymphedema (STRONG-B)

January 10, 2022 updated by: Pontificia Universidad Catolica de Chile

"Effect of Supervised Resistance Training on Arm Volume and Quality of Life amONG Women at High Risk for Breast Cancer-related Lymphedema: a Study Protocol for a Randomized Controlled Trial (STRONG-B)"

Breast cancer (BC) is the most common neoplasm in Chile, and its medical treatment leads to high survival. One-third of survivors will develop BC-related lymphedema. Lymphedema is a chronic condition characterized by increased volume in the ipsilateral arm to surgery. A higher volume is associated with decreased physical functionality and quality of life. Recent studies suggest that resistance training could control arm volume through increased muscle mass development, improving physical functionality and quality of life for patients. To our knowledge, there is no study that has analyzed the effect of a resistance training program among women at risk of BC-related lymphedema on arm volume and quality of life. The purpose of this study is to determine the effect of resistance training on the arm volume and quality of life among women with adjuvant chemotherapy and high risk of BC-related lymphedema compared to a control group with regular physical therapy management, which does not include resistance training.

This is a randomized controlled study. It will be held at the Complejo Asistencial Dr. Sotero del Río, which receives all patients from the South East Metropolitan Health Service. Participants: 106 women receiving adjuvant chemotherapy for BC who have undergone axillary lymph node dissection or with obesity will be recruited. The difference in volume between the arms will be evaluated with optoelectric equipment. Quality of life with The European Organization for Research and Treatment in Cancer Quality of Life C-30 (EORTC QLQ-C30) and the European Organization for Research and Treatment of Breast Cancer-Specific Quality of Life Questionnaire BR23 (EORTC QLQ-BR23) questionnaires, both validated in Chile; the handgrip with a dynamometer; and physical functionality with the six-minute walk test. Volunteers will be randomly assigned to the resistance training group or control group. The resistance training group will consist of twice a week supervised sessions, for 12 weeks. The exercises will be for arms and legs, self-loading type, and with external weights. The control group will follow the usual physical therapy management, which does not include resistance training. Subsequently, volunteers will be evaluated at the third and sixth months after completion of the 12 weeks resistance training program.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

106

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Karol Ramírez, Ph.D (c)
  • Phone Number: 22 3541168
  • Email: kramirezp@uc.cl

Study Locations

  • Chile
    • CO
      • Puente Alto, CO, Chile

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Newly diagnosed with stage I-III breast cancer, histologically confirmed.
  • Patients scheduled to receive adjuvant post-operative chemotherapy.
  • Partial or total mastectomy with axillary node dissection.
  • Partial or total mastectomy with sentinel node dissection with body mass index between 30.0 and 39.9 kg/m2.
  • Approval of their treating physician to participate in sub-maximal physiological fitness testing and a low to moderate progressive resistance exercise program.

Exclusion Criteria:

  • Inter-limb volume difference greater than 200 ml or 10%.
  • Previous antineoplastic treatment (chemotherapy, radiotherapy, or endocrine therapy).
  • Breast cancer stage IV
  • Unable to participate in an exercise program related to other medical problems.
  • Be identified as vigorous exercise behavior related to American College of Sports Medicine recommendations.
  • Body mass index lower than 18.5 kg/m2 or greater than 40 kg/m2.
  • Pregnancy.
  • Fluency and understanding of the Spanish language.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Resistance training group
Twice a week sessions supervised and group, during 12 weeks
Behavioral: Resistance Training
The resistance training will be for arms and legs, self-loading type, and external weights.
No Intervention: Control Group
The control group will follow the usual physical therapy management, which does not include resistance training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Arms lymphedema Volume on the Perometer System at 3, 6 and 9 months.
Time Frame: Baseline, 3, 6 and 9 months.
Perometer is considered the gold standard for determining lymphedema volume in research. Is a valid and reliable tool in volume measurement. It determines volume values expressed in milliliters and percentage. A value of 200 mL or 10% difference between one arm and the other is considered significant.
Baseline, 3, 6 and 9 months.
Change from Baseline in Health-related quality of life on questionnaire: The European Organization for Research and Treatment in Cancer (EORTC) Quality of Life C-30 (QLQ-C30) and breast cancer-specific module QLQ-BR23 at 3, 6, and 9 months.
Time Frame: Baseline, 3, 6 and 9 months.
The QLQ C-30 and specific module QLQ-BR23 are self-administered and validated questionnaires to assess health-related quality of life in patients with breast cancer. Both had been validated in Spanish language and on Chilean population. QLQ-C30 comprises 30 items to assess physical, role, emotional, cognitive, and social functioning. The QLQ-BR23 is a breast-specific module that comprises 23 questions to assess body image, sexual functioning, sexual enjoyment, future perspective, systemic therapy side effects. All scores were linearly transformed to a 0 to 100 scale. A high functional score represents a high or healthy level of functioning. A high QOL is defined by a high score for global health status or QOL. High symptom scores or items represent more severe symptoms or problems.
Baseline, 3, 6 and 9 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Hand grip strength on Hydraulic Hand Dynamometer at 3, 6 and 9 months.
Time Frame: Baseline, 3, 6, and 9 months.
Dynamometer assess the maximal voluntary grip strength (measured in kilograms). Each subject will perform six trials, three in each arm, with an alternating bilateral sequence. The results will be based on the best punctuation of the three trials, respectively. There are normative values in percentiles for healthy Chilean women.
Baseline, 3, 6, and 9 months.
Change from Baseline in Physical Fitness Six minute walk test at 3, 6 and 9 months.
Time Frame: Baseline and 3, 6 and 9 months.
Six minute walk test is a functional test of sub-maximum cardiorespiratory capacity. Valid and reliable in adults with cancer. Result are expressed in meters. A change of 20-30 meters is considered significant.
Baseline and 3, 6 and 9 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pontificia Universidad Catolica de Chile

Collaborators

Universidad de Granada
Hospital Dr Sotero del Rio
National Fund for Research and Development in Health, Chile

Investigators

  • Study Director: Irene Cantarero, Ph.D, Universidad de Granada
  • Principal Investigator: Karol Ramírez, Ph.D (c), Pontificia Universidad Catolica de Chile

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2021

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

March 11, 2021

First Submitted That Met QC Criteria

March 24, 2021

First Posted (Actual)

March 29, 2021

Study Record Updates

Last Update Posted (Actual)

January 13, 2022

Last Update Submitted That Met QC Criteria

January 10, 2022

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SA20I0060

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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