Clinical trial NCT01943695: Supervised Aerobic Training During or After Chemotherapy for Operable Breast Cancer
Official title: Optimal Timing Trial: Randomized Trial of Supervised Aerobic Training During or After Chemotherapy for Operable Breast Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: Breast Cancer
Exercise
Chemotherapy
15-178
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2013-09-17
Enrollment: 144
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to compare the effects of aerobic exercise training during and after chemotherapy for women who have recently been diagnosed with early-stage breast cancer.

The participant will be instructed to self-report the session information to ExOnc staff at or before their next scheduled visit. If the participant's next scheduled visit is greater than 72 hours following an unsupervised session, ExOnc staff may reach out to the participant to retrieve the session information. Unsupervised session details will be source documented by ExOnc staff.


Eligibility criteria: Inclusion Criteria:

* Aged 21-80 years
* Female
* MSK histologically confirmed early-stage operable breast cancer
* Scheduled to receive chemotherapy in the neoadjuvant or adjuvant setting
* ECOG status of 0 or 1
* Performing less than 150 minutes of structured moderate-intensity or strenuous intensity exercise per week
* If a female of child-bearing potential, must not be pregnant or planning to become pregnant during the study.

  a. Women \< 50 years old must have a negative pregnancy test (urine HCG or serum βHCG) within 2 weeks of beginning chemotherapy.
* Able to complete an acceptable baseline cardiopulmonary exercise test (CPET), in the absence of high risk ECG findings or other inappropriate response to exercise as determined by the investigator.
* Able to achieve an acceptable peak baseline CPET, as defined by any of the following criteria:

  * Achieving a plateau in oxygen consumption, concurrent with an increase in power output;
  * A respiratory exchange ratio ≥ 1.10;
  * Attainment of maximal predicted heart rate (HRmax) (i.e., within 10 bpm of age-predicted HRmax \[HRmax = 220-Age\[years\]);
  * Volitional exhaustion, as measured by a rating of perceived exertion (RPE) ≥ 18 on the BORG scale.
* Willingness to be randomized to one of the study arms

Exclusion Criteria:

* Presence of any other concurrent, actively treated malignancy
* History of any other malignancy treated within the past 3 years (other than non-melanoma skin cancer)
* Presence of metastatic disease
* Any of the following contraindications to cardiopulmonary exercise testing:
* Acute myocardial infarction within 3-5 days of any planned study procedures)
* Unstable angina
* Uncontrolled arrhythmia causing symptoms or hemodynamic compromise;
* Recurrent syncope
* Active endocarditis
* Acute myocarditis or pericarditis
* Symptomatic severe aortic stenosis
* Uncontrolled heart failure
* Acute pulmonary embolus or pulmonary infarction within 3 months of any planned study procedures;
* Thrombosis of lower extremities
* Suspected dissecting aneurysm
* Uncontrolled asthma
* Pulmonary edema
* Respiratory failure
* Acute non-cardiopulmonary disorders that may affect exercise performance or be aggravated by exercise (i.e., infection, renal failure, thyrotoxicosis) or
* Room air desaturation at rest ≤ 85%
* Mental impairment leading to inability to cooperate.
* Any other condition or intercurrent illness that, in the opinion of the investigator, makes the participant a poor candidate for the trial

Primary outcomes:
measure: Change in VO2 peak (functional capacity)
timeFrame: during chemotherapy 3-6 months depending on treatment recommendations
Secondary outcomes:
measure: Quality of Life measured by questionnaire during and after Chemotherapy
timeFrame: at baseline, mid-point (12 weeks approximately) , and follow-up (24 weeks approximately) testing
measure: Sleeping patterns as measured by questionnaire during and after Chemotherapy
timeFrame: at baseline, mid-point (12 weeks approximately) , and follow-up (24 weeks approximately) testing
measure: Depression scale during and after Chemotherapy
timeFrame: at baseline, mid-point (12 weeks approximately) , and follow-up (24 weeks approximately) testing
measure: Physical activity recall during and after Chemotherapy
timeFrame: at baseline, mid-point (12 weeks approximately) , and follow-up (24 weeks approximately) testing
measure: Skeletal Muscle Function
timeFrame: at baseline, mid-point (12 weeks approximately) , and follow-up (24 weeks approximately) testing
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Jessica Scott, PhD
role: PRINCIPAL_INVESTIGATOR
References: