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NCT01980368 Clinical Trial

Tai Chi Easy in Treating Cancer Survivors With Peripheral Sensory Neuropathy

Cancer Survivor Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT01980368
Other study ID # 12-007483
Secondary ID NCI-2016-0137312
Status Withdrawn
Phase N/A
First received July 12, 2013
Last updated March 8, 2018
Start date August 2013
Est. completion date January 18, 2017

Study information
Verified date March 2018
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date January 18, 2017
Est. primary completion date January 18, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• Educational Intervention
Receive readings and attend book club
Behavioral:
• Exercise Intervention
Receive Tai Chi Easy class, DVD, and exercise manual
Other:
• Questionnaire Administration
Ancillary studies

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Mayo Clinic National Cancer Institute (NCI)

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Changes in anxiety assessed by POMS Total Mood Disturbance dimensions (tension-anxiety) Baseline up to 2 months
Secondary 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
Secondary Changes in cognitive performance assessed by digit span and letter-number sequencing Baseline up to 2 months
Secondary Changes in depression assessed by Program Operations Manual System (POMS) Total Mood Disturbance dimensions (depression-dejection) Baseline up to 2 months
Secondary Changes in fatigue assessed by Fatigue Symptom Inventory Baseline up to 2 months
Secondary Changes in pain assessed by Medical Outcomes Study-Short Form 36 Baseline up to 2 months
Secondary Changes in sleep quality assessed by Pittsburgh Sleep Quality Index and actigraph Baseline up to 2 months
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