Clinical trial NCT03498157: IMpact of PRehabilitation in Oncology Via Exercise - Breast Cancer
Official title: IMpact of PRehabilitation in Oncology Via Exercise - Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Prehabilitation
Physical Activity
Surgery
Keywords: Prehabilitation
Exercise
Breast Cancer
Physical Activity
Surgery
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2018-04-13
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Safety of the exercise intervention (assessed by standardized questionnaire)
timeFrame: Through study intervention, an average of 3 weeks
measure: Feasibility of the exercise intervention (assessed via exercise logs)
timeFrame: Through study intervention, an average of 3 weeks
measure: Acceptability of the exercise intervention (assessed via patient flow diagram)
timeFrame: During Recruitment till first intervention is delivered (with one week after enrolment)
Secondary outcomes:
measure: Health-Related Quality of Life: EORTC QLQ-C30, version 3.0
timeFrame: Through study intervention, an average of 3 weeks; 6 weeks after surgery; and after the end of primary treatment, an average of 6 month after surgery
measure: Breast cancer-related symptoms and quality of Life
timeFrame: Through study intervention, an average of 3 weeks; 6 weeks after surgery; and after the end of primary treatment, an average of 6 month after surgery
measure: Fatigue
timeFrame: Through study intervention, an average of 3 weeks; 6 weeks after surgery; and after the end of primary treatment, an average of 6 month after surgery
measure: Sleep
timeFrame: Through study intervention, an average of 3 weeks; 6 weeks after surgery; and after the end of primary treatment, an average of 6 month after surgery
measure: Depression
timeFrame: Through study intervention, an average of 3 weeks; 6 weeks after surgery; and after the end of primary treatment, an average of 6 month after surgery
measure: Shoulder Problems
timeFrame: Through study intervention, an average of 3 weeks; 6 weeks after surgery; and after the end of primary treatment, an average of 6 month after surgery
measure: Physical activity behavior
timeFrame: Through study intervention, an average of 3 weeks; 6 weeks after surgery; and after the end of primary treatment, an average of 6 month after surgery
measure: Symptoms
timeFrame: Weekly from baseline to 6 weeks after Surgery
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Cancer Institute
state: Pennsylvania
Study officials:
affiliation: Penn State College of Medicine Hershey
name: Kathryn M Schmitz, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Center for Tumor Diseases, Heidelberg
name: Joachim Wiskemann, PhD
role: PRINCIPAL_INVESTIGATOR
References: