IMpact of PRehabilitation in Oncology Via Exercise - Breast Cancer
Completed · Not applicable
Conditions studied: Breast Cancer, Prehabilitation, Physical Activity, Surgery
In brief
The purpose of this study is to determine whether patients are able to participate in a so called prehabilitation program (prior to the beginning of cancer treatment) which includes (1) a supervised and home-based exercise program plus one educational session or (2) just home-based exercise plus one educational session or (3) just one educational session. 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.
Key facts
- Study ID
- NCT03498157
- Run by
- Milton S. Hershey Medical Center
- People needed
- 32
- Starts
- 2017-10-15
- Expected to finish
- 2019-07-01
- Last updated by the study team
- 2020-01-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Unilateral or bilateral primary carcinoma of the breast, confirmed histologically by core biopsy
- 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
You may not qualify if…
- Receiving neoadjuvant chemotherapy, radiotherapy or hormone therapy
- 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)
Where it is running
- Penn State Cancer Institute — Hershey, Pennsylvania, United States
Full record on ClinicalTrials.gov
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