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Hexarelin

Examorelin, HEX

Quick Stats
Studies 233
Trials 61
Completed NA INTERVENTIONAL NCT05114005

Tango for Neuropathy Among Breast Cancer Survivors

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

Group dance classes have been found to improve markers of quality of life and physical health (i.e., balance) among some populations engaged in rehabilitation, such as the elderly and individuals with Parkinson Disease. However, such interventions have yet to be studied among cancer survivors despite the relevance of quality of life and physical health within cancer survivorship. Group dance classes are a promising avenue in that they deliver activity-based medicine in a social context, thus potentially improving physical as well as psychosocial aspects of health. To further this avenue of inquiry, we propose to study the effect of dance-based interventions for cancer survivors.

Detailed Description

Participants will be randomized (1:1) to one of two activity intervention arms: Argentine Tango dance or home exercise. Information about neuropathy symptoms, motion, falls incidence, and participant feedback about the interventions will be collected. Aim1: To evaluate change in postural control over 16 sessions of Tango (exp) vs HEX (control) (n=26 per group) as primary endpoint. As secondary measures, to assess: balance function (i.e., TUG) and patient-reported outcomes (PROs) (i.e., symptoms, pain, fatigue, mood, quality of life) monthly including 1 month post-intervention completion; postural control and symptoms within-session; and falls incidence weekly for 6 months following intervention completion. Hypothesis: At primary endpoint, participants in the experimental group will show more improvement than participants in the control group in measures sensitive to neuropathy disease state (i.e., sway variability and area). Aim2: To evaluate change in gait variability after 16 sessions of Tango (exp) vs HEX (control) (n=26 per group; 1:1 randomization). As secondary measures, to analyze local and orbital dynamic stability (pre, post, and 1mo post-intervention), PROs (monthly), and falls incidence (weekly) following intervention completion. Hypothesis: At primary endpoint, participants in the experimental group will show more improvement than participants in the control group in measures of gait variability (i.e., stride-to-stride variability in speed).

Interventions

Name: Rhythmic Auditory Stimulation
Type: BEHAVIORAL
Description: Rhythmically-entrained sensorimotor activity.
Name: Evidence-Based Exercise
Type: BEHAVIORAL
Description: This program consists of information on neuropathy and fall prevention combined with a schedule of 1 hour training (i.e., endurance, resistance, and sensorimotor) performed 2x per week

Primary Outcomes

Measure: Postural Control (Variability)
TimeFrame: At baseline, week 8 of intervention, and at 4 week follow-up post intervention
Description: root-mean square of the center of pressure (COP)
Measure: Intrinsic Motivation
TimeFrame: Assessed at week 4, week 8, and week 12
Description: Intrinsic motivation will be measured using a subscale of the Intrinsic Motivation Inventory (IMI). The 6 item Interest/Enjoyment subscale of the IMI represents intrinsic motivation in an activity just performed as a possible score of 6 to 36 with 6 = most; 18 = neutral; 36 = least interesting/enjoyable. Specific items queried include whether the activity just performed was: enjoyable, enjoyed, boring (reverse order), interesting, fun, and able to hold the participant's attention.

Trial Information

NCT ID

NCT05114005

Status

Completed

Study Type

INTERVENTIONAL

Phases

NA

Sponsor

Ohio State University Comprehensive Cancer Center

Last Updated

December 15, 2025