Tai Chi Easy in Treating Cancer Survivors With Peripheral Sensory Neuropathy

Not Applicable

Withdrawn

• Conditions: Cancer Survivor; Peripheral Sensory Neuropathy
• Interventions: Behavioral: Exercise Intervention; Other: Educational Intervention; Other: Questionnaire Administration

• Registration Number: NCT01980368
• Lead Sponsor: Mayo Clinic

Brief Summary

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.

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 Timeline

• Study First Submitted: 2013-07-12
• Study Start: 2013-08
• Study First Submitted QC: 2013-11-04
• Study First Posted: 2013-11-11
• Primary Completion: 2017-01-18
• Study Completion: 2017-01-18
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-08
• Last Update Posted: 2018-03-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group I (Tai Chi Easy)	Exercise Intervention	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)	Questionnaire Administration	Patients receive readings each week and attend a book club to discuss the readings for 60 minutes once a week for 6 weeks.
Group I (Tai Chi Easy)	Questionnaire Administration	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)	Educational Intervention	Patients receive readings each week and attend a book club to discuss the readings for 60 minutes once a week for 6 weeks.

Primary Outcome Measures

Name	Time	Method
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	Baseline up to 2 months	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).

Secondary Outcome Measures

Name	Time	Method
Changes in body mass index assessed by weight and height	Baseline up to 2 months	Will be measured directly using standardized protocols with medical-quality calibrated balance scales.
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 anxiety assessed by POMS Total Mood Disturbance dimensions (tension-anxiety)	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