Cancer of the Breast, Chemotherapy-induced Neuropathy
Conditions
Keywords
survivorship, music, dance
Brief summary
Up to 80% of breast cancer survivors experience chemotherapy-induced neuropathy that impairs quality of life and increases fall risk long into survivorship, yet treatment options for neuropathy remain limited. The successful treatment will target neurophysiologic mechanisms for restoring function while addressing patient-reported symptoms and participation in treatment. Toward this end, the investigators propose to study a noninvasive, social sensorimotor intervention - Adapted Argentine Tango - which targets motor control restoration, symptom alleviation, and treatment participation in concert.
Detailed description
This study will investigate a noninvasive, social, sensorimotor intervention which targets motor control restoration, symptom alleviation, and treatment participation in concert: partnered Adapted Argentine Tango (Tango). This project will expand the investigators' pilot work (R21-AG068831) into a multicenter clinical trial designed to investigate the effect of social dance on sensory relief, functional restoration, and key mechanisms of action among a diverse cohort of BC survivors suffering from chronic chemotherapy-induced sensorimotor deficits.
Interventions
BEHAVIORALTango
The intervention being studied is a 16 session intervention (2x4-week modules), delivered over an 8-week period by community-based individuals with expertise in dance and patient care and certified in Adapted Tango or AdapTango dance instruction. Steps available to teach, including order and cues to teach them, are detailed in Hackney's AdapTango manual. All steps are based on the Argentine Tango steps that emerged within working class community centers in Buenos Aires, Argentina (milongas) in the late 1800s and have been adapted by the investigators for use as medical exercise among people with mobility deficits. Of note, Argentine Tango is distinct from, and the precursor for, the American Tango style of competitive ballroom dance: where American Tango highlights showmanship and complicated footwork, Argentine Tango prioritizes connection between partners and musicality within a basic walk motion.
Sponsors
National Institute on Aging (NIA)
Yale University
Emory University
Ohio State University Comprehensive Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Breast Cancer (BC) diagnosis of Stage I-IV including metastatic disease * completed taxane-based chemotherapy for BC at least 3 months ago (no limit on how long ago) * symptomatic for chemotherapy-induced neuropathy (self-report) * postural control score that indicates potential fall-risk * able to understand and comply with directions associated with testing and study treatments
Exclusion criteria
* pre-existing vestibular dysfunction * poorly controlled diabetes (hgA1C\>=8) * non-ambulatory (assistive and prosthetic devices allowed) * hearing impairment resulting in less than 10% hearing bilaterally * contraindication to participate in the experimental physical activity per the treating oncologist due to additional condition (e.g., herniated disc, unstable bone metastases) * currently in activity-based therapy (e.g., physical therapy, occupational therapy). May enroll if still meet eligibility criteria once activity-based therapy is complete.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient-Reported Outcome (PRO) - CIN sensation | 4 weeks | Sensation of numbness/tingling on 0-10 scale; minimum value 0 (no numbness/tingling); maximum value 10 (worst numbness/tingling) |
| Dual-task function | 4 weeks | Ability to move and think at the same time as measured by time to complete the Timed-Up-and-Go (TUG) test with concurrent cognitive task (i.e., counting backward by some number while completing a defined movement task) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Brief Pain Inventory | 4 weeks; 8 weeks; 12 weeks | The Brief Pain Inventory (BPI) is a self-reported questionnaire used to assess the severity of pain and how much it interferes with a person's daily activities, including aspects like mood, work, sleep, and social interactions. It measures pain intensity on a scale from 0 (no pain) to 10 (worst pain imaginable) across different timeframes (current, average, worst pain) while also evaluating the impact of pain on various life functions on a similar 0-10 scale; it comes in both short and long forms, with the long form including more detailed questions about pain characteristics and treatment history. |
| Biomechanical measures of postural control | 4 weeks; 8 weeks; 12 weeks | Postural sway while standing still with eyes closed. |
| Six minute walk test (6mwt) | 4 weeks; 8 weeks | A 6 minute walk test (6MWT) is a medical assessment where a person walks as far as they can in a designated area for six minutes, with the primary goal of measuring their functional exercise capacity, usually used to evaluate patients with conditions affecting their breathing or mobility, like heart failure or lung disease; the distance walked during those six minutes is the key measurement recorded as the 6-minute walk distance (6MWD) |
| Gait stability | 4 weeks; 8 weeks | Stability between gait strides over the period of the 6mwt. |
| Upper Extremity Function | 4 weeks; 8 weeks; 12 weeks | We assess upper extremity function using the back scratch test which measures upper body flexibility and shoulder mobility. Participants reach both hands toward each other behind their backs and staff measure the distance remaining between their fingertips. |
| Patient-Reported Outcome (PRO) - hot/cold sensation | 4 weeks; 8 weeks; 12 weeks | Sensation of hot and/or cold (11 point Likert scale). |
| EORTC-CIPN 20 | mid-intervention (4weeks); post -intervention (8 weeks); 1 month follow up post intervention | European Organization for Research and Treatment of Cancer Chemotherapy-Induced Peripheral Neuropathy symptoms inventory (CIPN 20), |
| Physical Health Questionnaire-2 (PHQ-2) | 4 weeks; 8 weeks; 12 weeks | The PHQ-2 asks how often a patient has experienced depressed mood or anhedonia in the last two weeks |
| Generalized Anxiety Questionnaire | 4 weeks; 8 weeks; 12 weeks | Each question has a 4-point scale, ranging from 1, not at all, to 4, nearly every day. |
| Brief Fatigue Inventory | 4 weeks; 8 weeks; 12 weeks | The Brief Fatigue Inventory (BFI) is a short questionnaire used to quickly assess the severity of fatigue, particularly in cancer patients, by measuring both the level of tiredness and how much fatigue interferes with daily activities, allowing for rapid evaluation in clinical settings or research studies; it consists of nine items where patients rate their fatigue on a scale from 0 to 10, with higher scores indicating greater fatigue severity. |
| Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) | 4 weeks; 8 weeks; 12 weeks | The PRO-CTCAE assessment, which stands for Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events, is a measurement system designed by the National Cancer Institute (NCI) to capture and evaluate the symptomatic side effects experienced by cancer patients during clinical trials, allowing patients to self-report on the frequency, severity, interference, and presence/absence of symptoms like pain, fatigue, nausea, and skin reactions, providing a more patient-centric perspective on treatment toxicity compared to clinician-based assessments alone. |
| Falls | 4 weeks; 8 weeks; 12 weeks; 6 months following intervention end | Report of whether you have fallen or lost your balanced since we last spoke with you |
| The Mini Balance Evaluation Systems Test (MiniBEST) | 4 weeks (Control group); 8 weeks (Intervention group) | The Mini-BESTest (Balance Evaluation Systems Test) is a 14-item test that measures balance, functional mobility, and gait by assessing dynamic balance, anticipatory postural adjustments, reactive postural control, sensory orientation, and dynamic gait. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Blood-based biomarkers of neuroplasticity | 4 weeks (Control group); 8 weeks (Intervention group) | BDNF and GFAP. These will be measured using the same units of measurement |
| Blood-based biomarkers of inflammation | 4 weeks (Control group); 8 weeks (Intervention group) | IL-6, IL-7, IL-8, IL-9, IL-10, TNF-alpha, IRN-gamma, MCP-1 |
| Blood-based biomarkers of neurotoxity | 4 weeks (Control group); 8 weeks (Intervention group) | Neurofilament chains, light density (NfL) |
| Brain Activity | 4 weeks (Control group); 8 weeks (Intervention group) | Electroencephalography (EEG)-based measures of brain activity during performance of functional activities (e.g., walking standing, thinking). We will analyze Alpha and Gamma frequencies with regard to amplitude and timing of peak activity. |
Countries
United States
Contacts
Primary ContactLise Worthen-Chaudhari, PhD, MFA, CMES
Outcome results
None listed