Evaluating Qigong as a Clinical Intervention for Cancer Survivors' Fatigue

Status unconfirmed · Not applicable

Conditions studied: Fatigue

In brief

This study compares Qigong movement-based meditation exercise with a healthy living exercise-wellness course. There are two primary goals of this research: 1. Evaluate and compare physiological mechanisms underlying the two wellness-exercise interventions with the specific goal of understanding the physiology of Qigong. Using a simple noninvasive EEG setup, the study will test some of the same brain mechanisms that have been found in mindfulness meditation. The study will also investigate Qigong's effects on stress and heart signals and on inflammation in the immune system. A key hypothesis is that Qigong will show distinctive, stronger effects on brain and heart measures. A related hypothesis is that Qigong will show stronger effects on blood markers of inflammation. 2. Compare effect sizes of the two interventions in decreasing fatigue in order to plan for a larger clinical trial.

Key facts

Study ID

NCT02845492

Run by

The Miriam Hospital

People needed

60

Starts

2016-07-01

Expected to finish

2017-12-01

Last updated by the study team

2016-08-01

Who can join

Age: 18 and older, up to 70. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Female patients
• Aged 18-70 years
• Self-report of fatigue =/> 3/10 on fatigue interference scale
• Have been diagnosed and completed treatment for cancer (with surgery or radiation or chemotherapy)
• no surgery, radiation or chemotherapy received in the past 8 weeks (ongoing treatment with Herceptin [trastuzumab] or other adjuvant therapies is permitted)
• Currently cancer-free
• Have a primary care or other physician
• Ability to understand English
• Willingness to have blood drawn, have an EEG taken and complete questionnaires
• Ability to pass basic validated physical movement tests (e.g.: standing with feet touching for 30 seconds, twist right to left and back, hold arms out to side in air for 15 seconds, lift arms over head, moving from standing position to seated position on the floor) to verify safety for Qigong practice.

You may not qualify if…

• History or current diagnosis of medical or psychiatric disorder that would interfere with ability to participate in wellness classes or in scientific assessment sessions (e.g., rheumatoid arthritis, diabetes, major psychiatric disorder, connective tissue disorder)
• Body Mass Index (BMI) > 31
• Active alcohol or drug abuse
• Tobacco use
• Pregnancy
• Regular daily use of anti-inflammatory drugs, including non-steroidal anti-inflammatory drugs, (does not apply to common use of daily "baby aspirin" as daily prophylactic cardiovascular treatment)
• Resting systolic blood pressure of less than 90 or greater than 160 and resting diastolic blood pressure of greater than 110.
• Ingestion of caffeine or cocoa products less than two hours from data collection
• Contraindication to regular physical activity participation
• Already engaging in >60 min of vigorous physical activity per week for the prior month
• Weekly practice of yoga, Tai Chi, Qigong, or meditation since the diagnosis of cancer
• Peripheral neuropathy

Where it is running

• Miriam Hospital — Providence, Rhode Island, United States (enrolling)

Full record on ClinicalTrials.gov

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