IMpact of PRehabilitation in Oncology Via Exercise - Breast Cancer
NCT ID: NCT03498157
Last Updated: 2020-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
32 participants
INTERVENTIONAL
2017-10-15
2019-07-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Breast cancer surgery may have potential for several side effects, including functional (e.g. flexibility in the affected arm, lymphedema \[swelling that generally occurs in the arms or legs that occurs as a result of the removal of or damage to lymph nodes as a part of cancer treatment\], shoulder pain) and psychosocial (e.g. reduced quality of life, increased fatigue) aspects.
Evidence shows that exercise is considered to be an effective treatment approach in breast cancer patients during and after treatment with regard to the above mentioned side-effects. Also, prehabilitative exercise in colon and lung cancer patients was shown as feasible and effective. However, no experience exits with regard to prehabilitation exercise in breast cancer patients.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Prehabilitation and RecOVERy From Surgery for Breast Cancer Study
NCT05901142
Adapted Physical Activity Effect on Aerobic Function and Fatigue at Home in Patients With Breast Cancer Treated in Adjuvant or Neoadjuvant Phase
NCT01795612
Breast Cancer Patients: A Breast Cancer Rehabilitation and Exercise Laboratory
NCT01157130
Breast Cancer Pre-habilitation and Prospective Surveillance to Prevent, Detect, and Optimize Physical and Function
NCT06081127
Exercise in Improving Health and Quality of Life in Breast Cancer Survivors
NCT03679559
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Partly Supervised Prehabilitation
Will be offered an initial one week (5 days for 3 hours each) supervised exercise prehabilitation program including a two hour group-based prehabilitation class at Penn State Rehabilitation Hospital, Hummelstown. The following weeks till surgery the learned exercise program should be done home-based for 5 times a week. A weekly phone call during this period will help to support and adapt the exercise program.
Exercise
The exercise intervention is an at least 2 weeks lasting (till the day surgery is taking place) 5-times weekly resistance training intervention combined with aerobic exercise (mostly walking).
Prehabilitation Education
Participate will receive a 2 hour group-based prehabilitation class which will be held at the Penn State Cancer Institute, Hershey
Home-based Prehabilitation
Will be offered an individual one-on-one appointment for an exercise introduction session with an exercise and cancer specialist and weekly phone calls to support and adapt the exercise program. The exercises should be done home-based for 5 times a week until the time of surgery. Furthermore, a two hour group-based prehabilitation class at the Penn State Hershey Cancer Institute will be offered.
Exercise
The exercise intervention is an at least 2 weeks lasting (till the day surgery is taking place) 5-times weekly resistance training intervention combined with aerobic exercise (mostly walking).
Prehabilitation Education
Participate will receive a 2 hour group-based prehabilitation class which will be held at the Penn State Cancer Institute, Hershey
Control Group
Will be offered a two hour group-based prehabilitation class at the Penn State Hershey Cancer Institute.
Prehabilitation Education
Participate will receive a 2 hour group-based prehabilitation class which will be held at the Penn State Cancer Institute, Hershey
Comparison group- women too active
Added comparison group: Women who are ineligible on the basis of 'engaging in systematic intense exercise training (at least 1h twice a week) will be recruited to complete measures only, with no randomization
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Exercise
The exercise intervention is an at least 2 weeks lasting (till the day surgery is taking place) 5-times weekly resistance training intervention combined with aerobic exercise (mostly walking).
Prehabilitation Education
Participate will receive a 2 hour group-based prehabilitation class which will be held at the Penn State Cancer Institute, Hershey
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Not metastatic (stage \<4)
* Females and males ≥18 years of age
* Fluent in written and spoken English
* Must be able to provide and understand informed consent
* Must have an ECOG PS of ≤ 2
* Scheduled for lump- or mastectomy at Penn State Cancer Institute
* ≥ 2 weeks till primary treatment
* Primary attending surgeon approval
Exclusion Criteria
* Not fluent in written and spoken English
* Evidence in the medical record of an absolute contraindication (e.g. Heart insufficiency \> NYHA III or uncertain arrhythmia; uncontrolled hypertension; severe renal dysfunction (GFR \< 30%, Creatinine\> 3mg/dl; insufficient hematological capacity like either hemoglobin value below 8 g/dl or thrombocytes below 30.000/µL; reduced standing or walking ability) for exercise
* Pregnant women
* Engaging in systematic intense exercise training (at least 1h twice per week)
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Milton S. Hershey Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Kathryn Schmitz
Professor, Public Health Sciences
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Kathryn M Schmitz, PhD
Role: PRINCIPAL_INVESTIGATOR
Penn State College of Medicine Hershey
Joachim Wiskemann, PhD
Role: PRINCIPAL_INVESTIGATOR
National Center for Tumor Diseases, Heidelberg
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Penn State Cancer Institute
Hershey, Pennsylvania, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PSCI # 17-051
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.