Yoga for Solid Tumor

Solid Tumor, Adult Clinical Trial

Official title:

A Pilot Study On The Effect Of Yoga On Fatigue, And Stress Levels In Solid Tumor Cancer Patients Undergoing Active Radiation Therapy

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03728205
• Other study ID #: UPCC 13918
• Secondary ID: 831417
• Status: Withdrawn
• Phase: N/A
• Start date: December 15, 2018
• Est. completion date: January 14, 2021

Study information

• Verified date: April 2021
• Source: Abramson Cancer Center of the University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 14, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumor, Adult

Intervention

Behavioral:
• Yoga
Twice weekly yoga sessions for 12 weeks

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abramson Cancer Center of the University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Long Term	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.	17 months
Primary	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.	Feasibility	12 months
Secondary	Effects on fatigue	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.	12 months
Secondary	Effects on Stress Level	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.	12 Months