Tai Chi Easy in Treating Cancer Survivors With Peripheral Sensory Neuropathy

NCT ID: NCT01980368

Last Updated: 2018-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2017-01-18

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cancer Survivor Peripheral Sensory Neuropathy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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 Type EXPERIMENTAL

Exercise Intervention

Intervention Type BEHAVIORAL

Receive Tai Chi Easy class, DVD, and exercise manual

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

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.

Group Type ACTIVE_COMPARATOR

Educational Intervention

Intervention Type OTHER

Receive readings and attend book club

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Educational Intervention

Receive readings and attend book club

Intervention Type OTHER

Exercise Intervention

Receive Tai Chi Easy class, DVD, and exercise manual

Intervention Type BEHAVIORAL

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Education for Intervention Intervention by Education Intervention through Education Intervention, Educational

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Donald Northfelt

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NCI-2016-01373

Identifier Type: REGISTRY

Identifier Source: secondary_id

12-007483

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA015083

Identifier Type: NIH

Identifier Source: secondary_id

View Link

12-007483

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

SINF: Peripheral Neuropathy in Cancer Survivors
NCT02168894 WITHDRAWN PHASE1/PHASE2