NCT03061773

Brief Summary

The treatment of breast cancer at any given time can be through surgery, as well as adjuvant treatments (radiotherapy, chemotherapy and hormone therapy) alone or together. And with this the patient tends to lose weight, he becomes depressed, resulting in an increasingly debilitating picture. Therefore, the present study aims to investigate the relationship between physical exercise and its effects on quality of life in patients with breast cancer, those who underwent surgery for at least 6 months, patients who are still with the Tumor using the adjuvant treatments submitted to physical exercises and not submitted. The sample will consist of 25 to 50 female patients aged 18 to 75 years. Patients will be submitted to the initial quality of life evaluation (SF - 36 reduced version, Anxiety and depression (HAD Scale), Fatigue (Piper Fatigue Scale), Pain (Brief Inventory of Pain), Body Composition (Bioimpedance BYODINAMICS 450 ) And oxidative stress markers (oxidized and reduced glutathione, TBARS / MDA, Myeloperoxidase and Creatinine), inflammatory markers (IL1, IL6, IL8, IL10, MCP-1 and TNF-α), hormones Estrogen, progesterone), blood test (complete blood count) 24 hour food recall (24hs food recall), and perform the maximum repetition test to find the initial workload that will be adjusted every 4 weeks with the evaluation of the load and Completing the 12 weeks of training will be reevaluated following the initial evaluation. The data collected will be treated statistically with an α=5% using the software Stata 12.0.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2015

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

February 14, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 23, 2017

Completed
Last Updated

February 23, 2017

Status Verified

February 1, 2017

Enrollment Period

1.5 years

First QC Date

February 14, 2017

Last Update Submit

February 19, 2017

Conditions

Breast Cancer Female

Outcome Measures

Primary Outcomes (1)

  • Measure the pain, The Brief Pain Inventory (BPI).

    Reduction of pain due to increased functional capacity

    12 weeks

Secondary Outcomes (1)

  • Measure the Fatigue; The revised piper fatigue scale (PFS-R).

    12 weeks

Study Arms (2)

Exercise group

EXPERIMENTAL

Exercise group: physical training lasting 12 weeks, after detraining and in the end the control group receives physical training

Other: Exercise

Group did not exercise

ACTIVE COMPARATOR

Group did not exercise: conventional hospital treatment

Behavioral: Conventional hospital treatment

Interventions

ExerciseOTHER

Physical training: The combined training program consisted of 12-week aerobic, resistive and flexibility exercises, with 3 sessions per week of aerobic and resistive training in the same session (supervised by physical exercise coaches) and 2 sessions per week of Flexibility training (unsupervised). As stretching sessions were interspersed with sessions of aerobic and weathered training in the daytime period.

Also known as: Physical exercise
Exercise group
Conventional hospital treatmentBEHAVIORAL

Conventional hospital treatment: The patients did not perform physical training

Group did not exercise

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Breast cancer patients;
  • Sedentary;
  • Currently at treatment and clinical follow-up.

You may not qualify if:

  • Musculoskeletal injuries or disorders;
  • Mental illnesses;
  • Enrolled in other exercise program.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • Backman M, Wengstrom Y, Johansson B, Skoldengen I, Borjesson S, Tarnbro S, Berglund A. A randomized pilot study with daily walking during adjuvant chemotherapy for patients with breast and colorectal cancer. Acta Oncol. 2014 Apr;53(4):510-20. doi: 10.3109/0284186X.2013.873820. Epub 2014 Jan 24.

    PMID: 24460069BACKGROUND

  • Do J, Cho Y, Jeon J. Effects of a 4-week multimodal rehabilitation program on quality of life, cardiopulmonary function, and fatigue in breast cancer patients. J Breast Cancer. 2015 Mar;18(1):87-96. doi: 10.4048/jbc.2015.18.1.87. Epub 2015 Mar 27.

    PMID: 25834616BACKGROUND

  • Nyrop KA, Callahan LF, Rini C, Altpeter M, Hackney B, Schecher A, Wilson A, Muss HB. Adaptation of an Evidence-Based Arthritis Program for Breast Cancer Survivors on Aromatase Inhibitor Therapy Who Experience Joint Pain. Prev Chronic Dis. 2015 Jun 11;12:E91. doi: 10.5888/pcd12.140535.

    PMID: 26068412BACKGROUND

  • Sullivan AB, Scheman J, Venesy D, Davin S. The role of exercise and types of exercise in the rehabilitation of chronic pain: specific or nonspecific benefits. Curr Pain Headache Rep. 2012 Apr;16(2):153-61. doi: 10.1007/s11916-012-0245-3.

    PMID: 22258395BACKGROUND

  • Travier N, Velthuis MJ, Steins Bisschop CN, van den Buijs B, Monninkhof EM, Backx F, Los M, Erdkamp F, Bloemendal HJ, Rodenhuis C, de Roos MA, Verhaar M, ten Bokkel Huinink D, van der Wall E, Peeters PH, May AM. Effects of an 18-week exercise programme started early during breast cancer treatment: a randomised controlled trial. BMC Med. 2015 Jun 8;13:121. doi: 10.1186/s12916-015-0362-z.

    PMID: 26050790BACKGROUND

  • Reis AD, Pereira PTVT, Diniz RR, de Castro Filha JGL, Dos Santos AM, Ramallo BT, Filho FAA, Navarro F, Garcia JBS. Effect of exercise on pain and functional capacity in breast cancer patients. Health Qual Life Outcomes. 2018 Apr 6;16(1):58. doi: 10.1186/s12955-018-0882-2.

    PMID: 29625622DERIVED

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • JOÃO BS GARCIA, Doctor

    Federal University of Maranhão

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Msc. Adult and Child Health and Researcher

Study Record Dates

First Submitted

February 14, 2017

First Posted

February 23, 2017

Study Start

March 1, 2014

Primary Completion

September 1, 2015

Study Completion

September 30, 2015

Last Updated

February 23, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share