Clinical trial NCT01980368: Tai Chi Easy in Treating Cancer Survivors With Peripheral Sensory Neuropathy
Official title: Pilot Study of Effects of Tai Chi Easy on Cancer Survivors Experiencing Neuropathy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cancer Survivor
Peripheral Sensory Neuropathy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2013-11-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Baseline up to 2 months
Secondary outcomes:
measure: Changes in anxiety assessed by POMS Total Mood Disturbance dimensions (tension-anxiety)
timeFrame: Baseline up to 2 months
measure: Changes in body mass index assessed by weight and height
timeFrame: Baseline up to 2 months
measure: Changes in cognitive performance assessed by digit span and letter-number sequencing
timeFrame: Baseline up to 2 months
measure: Changes in depression assessed by Program Operations Manual System (POMS) Total Mood Disturbance dimensions (depression-dejection)
timeFrame: Baseline up to 2 months
measure: Changes in fatigue assessed by Fatigue Symptom Inventory
timeFrame: Baseline up to 2 months
measure: Changes in pain assessed by Medical Outcomes Study-Short Form 36
timeFrame: Baseline up to 2 months
measure: Changes in sleep quality assessed by Pittsburgh Sleep Quality Index and actigraph
timeFrame: Baseline up to 2 months
Other outcomes:
Locations:
Study officials:
affiliation: Mayo Clinic
name: Donald Northfelt
role: PRINCIPAL_INVESTIGATOR
References: