Clinical trial NCT03789877: A Home-Based Walking Program and rTMS in Helping Breast Cancer Survivors Get More Physical Activity
Official title: Enhancing A Home-Based Walking Intervention Among Breast Cancer Survivors With rTMS: Feasibility and Limited Efficacy Testing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer Survivor
Invasive Breast Carcinoma
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
First posted: 2018-12-31
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This trial studies how well a home-based walking program, with or without repetitive transcranial magnetic stimulation, works in helping breast cancer survivors get more physical activity. Physical activity has been shown to improve health outcomes and quality of life among breast cancer survivors and can help lessen certain side effects of treatment such as fatigue, depression, and treatment-related weight gain. Repetitive transcranial magnetic stimulation is a procedure that uses electromagnets to stimulate brain activity. Using rTMS with a home-based walking program may help breast cancer survivors get more physical activity.

Detailed description: PRIMARY OBJECTIVES:

I. To examine the effects of 20 hertz (Hz) repetitive transcranial magnetic stimulation (rTMS) on delay discounting rates and multiple measures of self-regulation and walking.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients participate in a home-based exercise program of at least 10,000 steps per day (about 30 minutes of daily exercise) for 5 days weekly (150 minutes per week) for 12 weeks. Patients also undergo repetitive transcranial magnetic stimulation over 1 hour for 8 sessions during the first 2 weeks of the walking program.

GROUP II: Patients participate in a home-based exercise program of at least 10,000 steps per day (about 30 minutes of daily exercise) for 5 days weekly (150 minutes per week) for 12 weeks. Patients also undergo sham repetitive transcranial magnetic stimulation over 1 hour for 8 sessions during the first 2 weeks of the walking program.

Eligibility criteria: Inclusion Criteria:

* Have a previous history of invasive breast cancer who have completed treatment, except for hormonal therapy.
* Approved by a participant's physician to participate in this study.
* Have a smart phone or tablet with the capability of downloading the Fitbit activity tracker application, and a willingness to sync Fitbit activity tracker data with the application daily.
* Right handed.
* Pass the Transcranial Magnetic Stimulation Adult Safety and Screening questionnaire (TASS).
* Ability to speak and read English.

Exclusion Criteria:

* Pregnant or nursing.
* Have metastatic breast cancer.
* Morbidly obese as defined by a body mass index (BMI) \>= 40.
* Have any condition which would preclude receiving rTMS, including:

  * Personal history of epilepsy, head injury, aneurysm, stroke, or previous cranial neurosurgery or abnormal findings on the MRI (e.g., tumor, aneurysm, etc.)
  * A self-reported diagnosis of major depressive disorder, bipolar disorder or a schizophrenia-spectrum disorder, or tinnitus.
  * Metal implants or neuro-stimulators in the head, neck, or cochlea.
  * A pacemaker.
  * Known pre-existing noise induced hearing loss or concurrent treatment with ototoxic medications (i.e., aminoglycosides, cisplatin).
  * Use of anticonvulsant medication, or currently taking medications that lower seizure threshold (e.g., such as tricyclic antidepressants or bupropion).
  * Participants who score above 48.3 on the Claustrophobia questionnaire at the baseline assessment will be excluded because they are likely to be unable to undergo an Magnetic Resonance Imaging (MRI) without distress.
* Unwilling or unable to follow protocol requirements.
* Any condition which the principal investigator determines will make the participant an unsuitable candidate to participate in the study.

Primary outcomes:
measure: Delay discounting score
timeFrame: Baseline up to 6 months
measure: Number of steps per day
timeFrame: Baseline up to 6 months
measure: Number of minutes of moderate physical activity per day
timeFrame: Baseline up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
Study officials:
affiliation: Roswell Park Cancer Institute
name: Christine Sheffer
role: PRINCIPAL_INVESTIGATOR
References: