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Yoga for Solid Tumor

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03728205
Recruitment Status : Withdrawn (Covid-19)
First Posted : November 2, 2018
Last Update Posted : April 27, 2021
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania

Study Description
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Brief Summary:
The purpose of this study is to ascertain the effect of yoga interventions on radiation-related fatigue, and stress in cancer patients with stage I and II solid tumors.

Condition or disease Intervention/treatment Phase
Solid Tumor, Adult Behavioral: Yoga Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Pilot Study On The Effect Of Yoga On Fatigue, And Stress Levels In Solid Tumor Cancer Patients Undergoing Active Radiation Therapy
Actual Study Start Date : December 15, 2018
Actual Primary Completion Date : December 31, 2020
Actual Study Completion Date : January 14, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue

Arms and Interventions
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Arm Intervention/treatment
Experimental: Observational
All 10 pilot subjects will be taking yoga
 Behavioral: Yoga
Twice weekly yoga sessions for 12 weeks


Outcome Measures
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Primary Outcome Measures :
  1. The feasibility of implementing Eischens yoga interventions for solid tumor cancer patients undergoing radiation therapy. This will be measured by the success rate of recruitment and retention for 10 subjects. [ Time Frame: 12 months ]
    Feasibility


Secondary Outcome Measures :
  1. Effects on fatigue [ Time Frame: 12 months ]
    Examine the effect of yoga on cancer and radiation related fatigue during radiation therapy. We will use the BFI results both before, during and after radiation therapy.

  2. Effects on Stress Level [ Time Frame: 12 Months ]
    Examine the effect of yoga on cancer and radiation related fatigue during radiation therapy. We will use the NCCN Distress thermometer results both before, during and after radiation therapy.


Other Outcome Measures:
  1. Long Term [ Time Frame: 17 months ]
    Examine the long term effect of yoga to be tested at the 6 months post radiation visit. We will use the BFI and distress thermometer to see if any positive results during yoga are sustained to the 6 month follow up visit.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Stage I and II Cancer patients with solid tumors undergoing RT for 4-8 weeks (external beam radiation).
  2. Patients of age >18, and all races will be included in the study.
  3. All patients must sign an informed consent form approved for this purpose by the Institutional Review Board (IRB) of the University of Pennsylvania.
  4. Patients must be English speaking.

  5. Patients must be able to attend the schedule classes.

    Exclusion Criteria:

  6. Patients with medical restrictions that may interfere with or prevent them from taking part in the yoga interventions per their physician orders.
  7. Patients with metastatic disease.
  8. Active smokers. Smoking may interfere with relaxation and breathing modalities of the yoga interventions. (Self-reporting smokers that have been smoke free for 6 months may be included)
  9. Patients who currently practice or have recently practiced yoga (had not taken a yoga class on a regular bases in the last 6 months).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03728205


Locations
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United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
More Information
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Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03728205    
Other Study ID Numbers: UPCC 13918
831417 ( Other Identifier: Penn Medicine )
First Posted: November 2, 2018    Key Record Dates
Last Update Posted: April 27, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms