N/A
Completed N=40
Yoga or Educational Wellness Class for Women With Stage I, Stage II, or Stage III Breast Cancer Undergoing Chemotherapy
Source: ClinicalTrials.gov NCT00994279 ↗Enrolled (actual)
40
Serious AEs
5.3%
Results posted
Mar 2017
Primary outcomePrimary: Retention — 82; 89 percentage of participants — p=.53
Summary
RATIONALE: Yoga and wellness classes may reduce fatigue and improve mood, sleep, and quality of life in women receiving chemotherapy for breast cancer. It is not yet known whether yoga is more effective than wellness education for women with breast cancer who are undergoing chemotherapy.
PURPOSE: This randomized phase II trial is studying a community-based yoga class to see how well it works compared with an educational wellness class for women with stage I, stage II, or stage III breast cancer undergoing chemotherapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Retention |
82; 89 | .53 |
| SECONDARY Fatigue at 10 Weeks |
30.2; 30.1 | .98 |
Eligibility Criteria
Inclusion Criteria
Women will be eligible if they are:
- Scheduled to begin chemotherapy treatment within 3 weeks of study registration, or able to start Yoga/Wellness sessions prior to second chemotherapy treatment.
- ≥18 years of age.
- Physically able to attend yoga classes (simply meaning that they can physically make it to the intervention session and are able to sit on a chair or lie on the floor) (ECOG Performance Status rating 0-2; Zubrod et al., 1960).
- Diagnosed with breast cancer Stages I-III.
- Chemotherapy is anticipated to continue during the 10 weeks of the study intervention.
- 2-8 weeks post-completion of breast surgery (unless receiving neoadjuvant chemotherapy).
- Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria
- Have practiced yoga on a regular basis (at least once a week) within the past 4 weeks to recruit women who are not already regularly practicing yoga. Given that the benefits of yoga are likely more immediate than long-term, however, we will enroll women who have previously had a yoga practice.
- Are being treated with surgery and/or radiation therapy and/or hormonal treatment only and/or Herceptin therapy only (no chemotherapy).
- Anticipate undergoing surgery related to their breast cancer or receipt of radiation therapy during the study period.
- Have regularly engaged in moderate (activity that makes you breathe somewhat harder than normal; may include carrying light loads, bicycling at a regular pace, fast walking, tennis, easy swimming, or popular or folk dancing) or vigorous (activity that causes heavy breathing, sweating, rapid fatigue; it can only be sustained for very short periods of time, like running or swimming strongly) physical activity at least 3-5 days per week (on average) within the past 4 weeks.
Pregnant women will not be excluded from this study because the study intervention(s) pose no risk of potential for teratogenic or abortifacient effects. In fact, gentle yoga practice is quite safe for pregnant women and poses can be slightly modified, if needed. The anticipated number of pregnant women eligible to enroll is minimal.
Data sourced from ClinicalTrials.gov (NCT00994279). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.