Supervised Resistance TRaining amONG Women at Risk of Breast Cancer Related Lymphedema

Breast Cancer Clinical Trial

— STRONG-B  

Official title:

"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)"

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04821609
• Other study ID #: SA20I0060
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: June 2023

Study information

• Verified date: December 2021
• Source: Pontificia Universidad Catolica de Chile
• Contact: Karol Ramírez, Ph.D (c)
• Phone: 22 3541168
• Email: kramirezp[@]uc.cl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 106
• Est. completion date: June 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Cancer Lymphedema
• Breast Neoplasms
• Lymphedema
• Lymphedema of Upper Arm
• Physical Activity

Intervention

Behavioral:
• Resistance Training
The resistance training will be for arms and legs, self-loading type, and external weights.

Locations

Country	Name	City	State
Chile	Karol Ramírez	Puente Alto	CO

Sponsors (4)

Lead Sponsor	Collaborator
Pontificia Universidad Catolica de Chile	Hospital Dr Sotero del Rio, National Fund for Research and Development in Health, Chile, Universidad de Granada

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Arms lymphedema Volume on the Perometer System at 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.
Primary	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.	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	Change from Baseline in Hand grip strength on Hydraulic Hand Dynamometer at 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.
Secondary	Change from Baseline in Physical Fitness Six minute walk test at 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.