Women With Stage I or II Breast Cancer Undergoing Active Radiation Therapy Clinical Trial
Official title:
A Randomized Study of the Effect of Yoga in Patients With Breast Cancer Receiving Radiation Therapy
| NCT number | NCT01985945 |
| Other study ID # | UPCC 08113 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | March 2013 |
| Est. completion date | December 31, 2015 |
| Verified date | March 2020 |
| Source | Abramson Cancer Center of the University of Pennsylvania |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to examine the use of Eischens yoga for 8 weeks in one cohort of 20 women with stage I and II breast cancer receiving radiation therapy treatment, while a second cohort of the same type of and number of patients who, instead of yoga will receive standard supportive therapy, Questionnaire measuring cancer-related quality of life (FACT-G instrument) and fatigue (Brief Fatique Inventory) will be given to patients at several points.
| Status | Completed |
| Enrollment | 70 |
| Est. completion date | December 31, 2015 |
| Est. primary completion date | July 2015 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Stage I and II breast cancer patients undergoing active radiation therapy - Above the age of 18 - Must sign informed consent form - Must speak English - Only women are eligible Exclusion Criteria: - Patients with medical restrictions that may interfere with yoga participation per their physicians' decision - Those who have smoked in the last 6 months because smoking can interfere with the breathing and relaxation techniques of yoga. - Those who have regularly taken yoga in the last 6 months, because they would not come to the intervention with the same baseline as other participants. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Abramson Cancer Center of the University of Pennsylvania | Philadelphia | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| Abramson Cancer Center of the University of Pennsylvania |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Adverse Events | One Year |