DAANCE FOR CHEMOTHERAPY-INDUCED NEUROPATHY

Официальное название

DANCE-BASED AVENUES TO ADVANCE NONPHARMACOLOGIC TREATMENT OF CHEMOTHERAPY EFFECTS (DAANCE): A MULTICENTER TRIAL

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Tango
  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 t

Первичные конечные точки

• Patient-Reported Outcome (PRO) - CIN sensation [Срок оценки: 4 weeks]
• Dual-task function [Срок оценки: 4 weeks]

Вторичные конечные точки (12)

• Patient-Reported Outcome (PRO) - hot/cold sensation [Срок оценки: 4 weeks; 8 weeks; 12 weeks]
• EORTC-CIPN 20 [Срок оценки: mid-intervention (4weeks); post -intervention (8 weeks); 1 month follow up post intervention]
• Brief Fatigue Inventory [Срок оценки: 4 weeks; 8 weeks; 12 weeks]
• Brief Pain Inventory [Срок оценки: 4 weeks; 8 weeks; 12 weeks]
• Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) [Срок оценки: 4 weeks; 8 weeks; 12 weeks]
• Physical Health Questionnaire-2 (PHQ-2) [Срок оценки: 4 weeks; 8 weeks; 12 weeks]
• Generalized Anxiety Questionnaire [Срок оценки: 4 weeks; 8 weeks; 12 weeks]
• Falls [Срок оценки: 4 weeks; 8 weeks; 12 weeks; 6 months following intervention end]
• The Mini Balance Evaluation Systems Test (MiniBEST) [Срок оценки: 4 weeks (Control group); 8 weeks (Intervention group)]
• Biomechanical measures of postural control [Срок оценки: 4 weeks; 8 weeks; 12 weeks]
• Six minute walk test (6mwt) [Срок оценки: 4 weeks; 8 weeks]
• Gait stability [Срок оценки: 4 weeks; 8 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 2 центра

• Yale University — New Haven
• The Ohio State University — Columbus

Публикации

• Worthen-Chaudhari L, Bing J, Schmiedeler JP, Basso DM. A new look at an old problem: defining weight acceptance in human walking. Gait Posture. 2014;39(1):588-92. doi: 10.1016/j.gaitpost.2013.09.012. Epub 2013 Sep 28. PMID 24139684
• Worthen-Chaudhari L, Schnell PM, Hackney ME, Lustberg MB. Partnered dance evokes greater intrinsic motivation than home exercise as therapeutic activity for chemotherapy-induced deficits: secondary results of a randomized, controlled clinical trial. Front Psychol. 2024 Jun 19;15:1383143. doi: 10.3389/fpsyg.2024.1383143. eCollection 2024. PMID 38962217
• Worthen-Chaudhari LC, Crasta JE, Schnell PM, Lantis K, Martis J, Wilder J, Bland CR, Hackney ME, Lustberg MB. Neurologic dance training and home exercise improve motor-cognitive dual-task function similarly, but through potentially different mechanisms, among breast cancer survivors with chemotherapy-induced neuropathy: Initial results of a randomized, controlled clinical trial. J Alzheimers Dis. PMID 39584292
• Worthen-Chaudhari L, Lamantia MT, Monfort SM, Mysiw W, Chaudhari AMW, Lustberg MB. Partnered, adapted argentine tango dance for cancer survivors: A feasibility study and pilot study of efficacy. Clin Biomech (Bristol). 2019 Dec;70:257-264. doi: 10.1016/j.clinbiomech.2019.08.010. Epub 2019 Aug 22. PMID 31751861
• Worthen-Chaudhari LC, Monfort SM, Bland C, Pan X, Chaudhari AMW. Characterizing within-subject variability in quantified measures of balance control: A cohort study. Gait Posture. 2018 Jul;64:141-146. doi: 10.1016/j.gaitpost.2018.05.031. Epub 2018 Jun 2. PMID 29908434
• Mezzanotte JN, Grimm M, Shinde NV, Nolan T, Worthen-Chaudhari L, Williams NO, Lustberg MB. Updates in the Treatment of Chemotherapy-Induced Peripheral Neuropathy. Curr Treat Options Oncol. 2022 Jan;23(1):29-42. doi: 10.1007/s11864-021-00926-0. Epub 2022 Feb 15. PMID 35167004
• Luciani BD, Alwan A, Carlson M, McNally G, Hackney ME, Crasta JE, Schnell P, Lustberg MB, Worthen-Chaudhari L. Dance-based avenues to advance nonpharmacologic treatment of chemotherapy effects (DAANCE): study protocol for a multi-center, randomized controlled trial. Trials. 2026 Feb 21;27(1):246. doi: 10.1186/s13063-026-09486-w. PMID 41723535
• Luciani B, Carlson M, McNally G, Hackney ME, Crasta JE, Schnell P, Lustberg MB, Worthen-Chaudhari L. Dance-based avenues to advance nonpharmacologic treatment of chemotherapy effects (DAANCE): Study protocol for a multi-center, randomized controlled trial. Res Sq [Preprint]. 2025 Jul 7:rs.3.rs-6814353. doi: 10.21203/rs.3.rs-6814353/v1. PMID 40671809

Идентификаторы

NCT: NCT06749210 · OSU-24277 · R01AG084676 · OSU-24277

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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