DAANCE FOR CHEMOTHERAPY-INDUCED NEUROPATHY

ConditionsCancer of the Breast Chemotherapy-induced Neuropathy

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age40+

SponsorOhio State University Comprehensive Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

Tango
Behavioral
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.

Treatment groups

140 Participants

are divided into 2 treatment groups

Group A: ControlNo intervention 0 interventions

Group B: ExperimentalExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Patient-Reported Outcome (PRO) - CIN sensation

Sensation of numbness/tingling on 0-10 scale; minimum value 0 (no numbness/tingling); maximum value 10 (worst numbness/tingling)

Time frame

4 weeks

Dual-task function

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)

Time frame

4 weeks

Secondary outcomes

Patient-Reported Outcome (PRO) - hot/cold sensation

Sensation of hot and/or cold (11 point Likert scale).

Time frame

4 weeks; 8 weeks; 12 weeks

EORTC-CIPN 20

European Organization for Research and Treatment of Cancer Chemotherapy-Induced Peripheral Neuropathy symptoms inventory (CIPN 20),

Time frame

mid-intervention (4weeks); post -intervention (8 weeks); 1 month follow up post intervention

Brief Fatigue Inventory

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.

Time frame

4 weeks; 8 weeks; 12 weeks

Brief Pain Inventory

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.

Time frame

4 weeks; 8 weeks; 12 weeks

Other outcomes

Brain Activity

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.

Time frame

4 weeks (Control group); 8 weeks (Intervention group)

Blood-based biomarkers of inflammation

IL-6, IL-7, IL-8, IL-9, IL-10, TNF-alpha, IRN-gamma, MCP-1

Time frame

4 weeks (Control group); 8 weeks (Intervention group)

Blood-based biomarkers of neurotoxity

Neurofilament chains, light density (NfL)

Time frame

4 weeks (Control group); 8 weeks (Intervention group)

Blood-based biomarkers of neuroplasticity

BDNF and GFAP. These will be measured using the same units of measurement

Time frame

4 weeks (Control group); 8 weeks (Intervention group)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ohio State University Comprehensive Cancer Center

Lead sponsor

National Institute on Aging (NIA)

Collaborator

Yale University

Collaborator

Emory University

Collaborator

Source ClinicalTrials.gov

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