Tai Chi Easy in Treating Cancer Survivors With Peripheral Sensory Neuropathy

Pilot Study of Effects of Tai Chi Easy on Cancer Survivors Experiencing Neuropathy

This pilot clinical trial studies how well Tai Chi Easy works in treating cancer survivors with peripheral sensory neuropathy. Tai Chi Easy is a simple and repetitive form of exercise that consists of movements with meditation and may improve peripheral neuropathy symptoms among cancer survivors.

Study Overview

• Status: Withdrawn
• Conditions: Cancer Survivor; Peripheral Sensory Neuropathy
• Intervention / Treatment: Other: Questionnaire Administration; Behavioral: Exercise Intervention; Other: Educational Intervention

Detailed Description

PRIMARY OBJECTIVES:

I. Examine effects of Tai Chi Easy (TCEasy) exercise intervention on peripheral sensory neuropathy of cancer survivors who have chemotherapy compared with an educational control (EC) intervention.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I (TAI CHI EASY): Patients attend Tai Chi Easy class for 60 minutes once a week for 6 weeks. Patients also receive a DVD and exercise manual of Tai Chi Easy exercises and are encouraged to practice at home for 30 minutes most days per week for 6 weeks.

GROUP II (EDUCATIONAL CONTROL): Patients receive readings each week and attend a book club to discuss the readings for 60 minutes once a week for 6 weeks.

After completion of study, patients are followed up at 2 months.

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 1 month - 5 years following completion of cytotoxic chemotherapy treatment for any cancer, and are experiencing neuropathy
• Self-report of >= 4 on the Peripheral Neuropathy Question

Exclusion Criteria:

• Recurrence of cancer or other active cancer
• Severe cachexia, dizziness, bone pain, or severe nausea (as judged by the investigator)
• Uncontrolled diabetes, untreated hypothyroidism

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group I (Tai Chi Easy); Patients attend Tai Chi Easy class for 60 minutes once a week for 6 weeks. Patients also receive a DVD and exercise manual of Tai Chi Easy exercises and are encouraged to practice at home for 30 minutes most days per week for 6 weeks.	Other: Questionnaire Administration; Ancillary studies; Behavioral: Exercise Intervention; Receive Tai Chi Easy class, DVD, and exercise manual
Active Comparator: Group II (educational control); Patients receive readings each week and attend a book club to discuss the readings for 60 minutes once a week for 6 weeks.	Other: Questionnaire Administration; Ancillary studies; Other: Educational Intervention; Receive readings and attend book club; Other Names: Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in peripheral sensory neuropathy, assessed by Peripheral Neuropathy Question, European Organization for Research and Treatment of Cancer (EORTC)-30, EORTC-Chemotherapy-induced peripheral neuropathy-20, and the modified Total Neuropathy Score	Will be assessed with a simple t-test of mTNS means. Additional analyses of factors assessed will similarly be conducted (and overall analysis of variance when combining outcome variable assessment at the three time points, and models of factor contribution with logistic regression if appropriate).	Baseline up to 2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in anxiety assessed by POMS Total Mood Disturbance dimensions (tension-anxiety)		Baseline up to 2 months
Changes in body mass index assessed by weight and height	Will be measured directly using standardized protocols with medical-quality calibrated balance scales.	Baseline up to 2 months
Changes in cognitive performance assessed by digit span and letter-number sequencing		Baseline up to 2 months
Changes in depression assessed by Program Operations Manual System (POMS) Total Mood Disturbance dimensions (depression-dejection)		Baseline up to 2 months
Changes in fatigue assessed by Fatigue Symptom Inventory		Baseline up to 2 months
Changes in pain assessed by Medical Outcomes Study-Short Form 36		Baseline up to 2 months
Changes in sleep quality assessed by Pittsburgh Sleep Quality Index and actigraph		Baseline up to 2 months

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Donald Northfelt, Mayo Clinic

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): January 18, 2017
• Study Completion (Actual): January 18, 2017

Study Registration Dates

• First Submitted: July 12, 2013
• First Submitted That Met QC Criteria: November 4, 2013
• First Posted (Estimate): November 11, 2013

Study Record Updates

• Last Update Posted (Actual): March 12, 2018
• Last Update Submitted That Met QC Criteria: March 8, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases
• Other Study ID Numbers: 12-007483 (Other Identifier: Mayo Clinic in Arizona); P30CA015083 (U.S. NIH Grant/Contract); NCI-2016-01373 (Registry Identifier: CTRP (Clinical Trial Reporting Program))