Adaptations to Breast Cancer and Exercise

Breast Cancer Clinical Trial

— ABRACE  

Official title:

Effects of Different Volumes of Combined Training on Neuromuscular Parameters of Women in Initial Treatment for Breast Cancer: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03314168
• Other study ID #: 72983017.3.0000.5347
• Status: Recruiting
• Phase: N/A
• Start date: October 7, 2017
• Est. completion date: August 30, 2025

Study information

• Verified date: May 2022
• Source: Federal University of Rio Grande do Sul
• Contact: Joao Henkin, BsC
• Phone: +5551 99302 3340
• Email: joaohenkin[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to investigate the effects of different volumes of combined training on fatigue, neuromuscular variables, morphological, cardiorespiratory capacity, functionality, and quality of life, in breast cancer (BCa) women undergoing primary treatment. Two thirds will be the intervention group that will perform combined training, while the other third will be the control group that will have physiotherapy sessions.

Description:

Although chemotherapy and radiation are mainstream treatment modalities, patients will often experience treatment-related side effects such as impairments to the neuromuscular and cardiovascular systems and reduction in quality of life (QoL).To date, numerous positive effects on neuromuscular and aerobic parameters in response to resistance and aerobic training have been reported when both training modalities were simultaneously performed (i.e. combined training - COMB) in BCa patients. However, there is a lack of data regarding the prescription of this modality in BCa patients, as the necessary dose of resistance training for significant improve in fatigue, neuromuscular, and quality of life. In this sense, no previous studies investigate the effect of different volumes of resistance training in BCa patients, providing important informations about the prescription in this clinical population.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: August 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Breast cancer diagnostic at I and II stages;
• Adjuvant or neoadjuvant chemotherapy (=50% of sessions completed);
• More than 18 years.

Exclusion Criteria:

• Current smoking
• Diabetic neuropathy;
• Hypertension uncontrolled;
• Heart failure;
• Clinical depression;
• Skeletal muscle impairment which not allow physical exercise.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• Combined training
Resistance exercises performed with different volumes (i.e. one-single set and multiple-sets) and 20-25 minutes of aerobic exercise will be performed twice a week, during 12 weeks.
• Control group
The usual care will be recommended to avoid systematic physical exercise for 3 months and will receive general clinical recommendations such as nutritional intake and lifestyle issues in their respective hospital.

Locations

Country	Name	City	State
Brazil	Hospital Moinhos de Vento	Pôrto Alegre
Brazil	Universidade Federal do Rio Grande do Sul	Pôrto Alegre

Sponsors (2)

Lead Sponsor	Collaborator
João Henkin	Hospital Moinhos de Vento

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neuromuscular fatigue	Fatigue will be assessed by Fatigue index in isokinetic device.	Changes from baseline are assessed after the intervention (week 13)
Primary	Subjective fatigue	Fatigue will be assessed by Piper fatigue scale (PFS). The PFS in its current form is composed of 22 numerically scaled, "0" to "10" items (i.e. 0, none fatigue; 10, severe fatigue) that measure four dimensions of subjective fatigue: behavioral/severity (6 items; # 2-7); affective meaning (5 items: # 8-12); sensory (5 items: # 13-17); and cognitive/mood (6 items: # 18-23). These 22 items are used to calculate the four sub-scale/dimensional scores and the total fatigue scores.	Changes from baseline are assessed after the intervention (week 13)
Secondary	Body composition	Body composition will be assessed by Dual-energy X-ray absorptiometry	Changes from baseline are assessed after the intervention (week 13)
Secondary	Muscle thickness	Muscle thickness will be assessed by ultrasound images of quadriceps femoris and biceps.	Changes from baseline are assessed after the intervention (week 13)
Secondary	Echo intensity	Echo intensity is a grey scale for analyze the image that ranging from 0 (black) to 255 (white), and will be assessed by ultrasound images of quadriceps femoris and biceps.	Changes from baseline are assessed after the intervention (week 13)
Secondary	VO2máx	VO2máx will be assessed by an incremental protocol in a cycle ergometer	Changes from baseline are assessed after the intervention (week 13)
Secondary	Knee extension muscle strength	Knee extension muscle strength will be assessed by a bilateral 1-repetition maximum, reported in Kg.	Changes from baseline are assessed after the intervention (week 13)
Secondary	Unilateral vertical bench press muscle strength	Unilateral vertical bench press muscle strength will be assessed by an unilateral 1-repetition maximum on both sides, reported in Kg.	Changes from baseline are assessed after the intervention (week 13)
Secondary	Knee extension peak torque	Knee extension peak torque will be assessed by maximal voluntary isometric contraction on the right side, in a isokinetic dynamometer.	Changes from baseline are assessed after the intervention (week 13)
Secondary	Quality of life assessed by European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30+Br23	Quality of life will be assessed by European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30+Br23. The EORTIC is composed by 53 questions scaled "0" to "4", and "0" to "7". These 53 items are used to compute four domains (i.e. global, functions, symptoms, and BR23 functions).	Changes from baseline are assessed after the intervention (week 13)
Secondary	Functional Performance: Timed-up and go test	The timed-up-and-go requires an individual to stand up from a seated position in a chair, walk 2.44m, turn around a cone, walk back to the chair and sit down.	Changes from baseline are assessed after the intervention (week 13)
Secondary	Functional performance: 5-repetitions Sit-to-stand test	For the 5-repetition sit-to-stand test, participants are instructed to start the test in a seated position with arms folded across the chest. After the start command, participants stand up until full knees extension and then back to a seated position. The time is stopped when the participants touch the seat after five complete repetitions.	Changes from baseline are assessed after the intervention (week 13)
Secondary	Functional performance: 30-seconds arm-curl	The arm-curl test determines the maximal number of times a 2kg dumbbell can be lifted with the dominant arm through elbow flexion in 30 seconds. Participants start the test seated in a chair, with arms extended and forearm maintained in supinated position during full range of motion.	Changes from baseline are assessed after the intervention (week 13)
Secondary	Functional Performance: Stair Climbing	For the stair-climbing test, participants are instructed to climb a 10-step staircase without skip steps or using the handrail (except in need of balance to prevent falls	Changes from baseline are assessed after the intervention (week 13)