Trial Outcomes & Findings for Yoga or Educational Wellness Class for Women With Stage I, Stage II, or Stage III Breast Cancer Undergoing Chemotherapy (NCT NCT00994279)

NCT ID: NCT00994279

Last Updated: 2021-10-20

Results Overview

Proportion of participants completing the 10 week study

Recruitment status

COMPLETED

Study phase

Target enrollment

40 participants

Primary outcome timeframe

10 weeks

Results posted on

2021-10-20

Participant Flow

Participants were recruited from three NCI CCOP sites between 1/2010 and 8/2011

Participant milestones

Participant milestones
Measure	Arm 1: Yoga Intervention Yoga Intervention Yoga: Yoga sessions	Arm 2: Educational Wellness Group Educational Wellness Group Education: Educational Wellness Group
Overall Study STARTED	22	18
Overall Study COMPLETED	18	13
Overall Study NOT COMPLETED	4	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm 1: Yoga Intervention Yoga Intervention Yoga: Yoga sessions	Arm 2: Educational Wellness Group Educational Wellness Group Education: Educational Wellness Group
Overall Study Withdrawal by Subject	2	2
Overall Study Toxicity	1	0
Overall Study Multiple reasons	1	3

Baseline Characteristics

Yoga or Educational Wellness Class for Women With Stage I, Stage II, or Stage III Breast Cancer Undergoing Chemotherapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1: Yoga Intervention n=22 Participants Yoga Intervention Yoga: Yoga sessions	Arm 2: Educational Wellness Group n=18 Participants Educational Wellness Group Education: Educational Wellness Group	Total n=40 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=5 Participants	18 Participants n=7 Participants	37 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Age, Continuous	50 years n=5 Participants	45 years n=7 Participants	47 years n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	18 Participants n=7 Participants	40 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	22 Participants n=5 Participants	18 Participants n=7 Participants	40 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) White	20 Participants n=5 Participants	15 Participants n=7 Participants	35 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	22 participants n=5 Participants	18 participants n=7 Participants	40 participants n=5 Participants

PRIMARY outcome

Timeframe: 10 weeks

Population: All randomized participants

Proportion of participants completing the 10 week study

Outcome measures

Outcome measures
Measure	Arm 1: Yoga Intervention n=22 Participants Yoga Intervention Yoga: Yoga sessions	Arm 2: Educational Wellness Group n=18 Participants Educational Wellness Group Education: Educational Wellness Group
Retention	82 percentage of participants Interval 60.0 to 95.0	89 percentage of participants Interval 65.0 to 99.0

SECONDARY outcome

Timeframe: 10 weeks

Population: Participants with 10 week outcome data. Note that one participant in the Wellness group was missing this outcome even though they completed the study.

FACIT-Fatigue patient reported outcome. This questionnaire consists of 13 questions answered on a 0 to 4 scale with a min of 0 and a max of 52. Higher scores indicate less fatigue.

Outcome measures

Outcome measures
Measure	Arm 1: Yoga Intervention n=18 Participants Yoga Intervention Yoga: Yoga sessions	Arm 2: Educational Wellness Group n=15 Participants Educational Wellness Group Education: Educational Wellness Group
Fatigue at 10 Weeks	30.2 units on a scale Standard Error 2.6	30.1 units on a scale Standard Error 2.9

Adverse Events

Arm 1: Yoga Intervention

Serious events: 1 serious events

Other events: 11 other events

Deaths: 0 deaths

Arm 2: Educational Wellness Group

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm 1: Yoga Intervention n=21 participants at risk Yoga Intervention Yoga: Yoga sessions	Arm 2: Educational Wellness Group n=17 participants at risk Educational Wellness Group Education: Educational Wellness Group
Blood and lymphatic system disorders Febrile Neutropenia	0.00% 0/21 • 14 weeks Sample includes all patients with follow-up toxicity assessments. This number is different from the sample size in other analyses because some participants provided follow-up toxicity assessments before they went off study. Patients were asked about adverse events at each assessment visit.	5.9% 1/17 • Number of events 1 • 14 weeks Sample includes all patients with follow-up toxicity assessments. This number is different from the sample size in other analyses because some participants provided follow-up toxicity assessments before they went off study. Patients were asked about adverse events at each assessment visit.
Cardiac disorders Heart Failure	4.8% 1/21 • Number of events 1 • 14 weeks Sample includes all patients with follow-up toxicity assessments. This number is different from the sample size in other analyses because some participants provided follow-up toxicity assessments before they went off study. Patients were asked about adverse events at each assessment visit.	0.00% 0/17 • 14 weeks Sample includes all patients with follow-up toxicity assessments. This number is different from the sample size in other analyses because some participants provided follow-up toxicity assessments before they went off study. Patients were asked about adverse events at each assessment visit.

Other adverse events

Additional Information

Dr. Doug Case

Wake Forest NCI NCORP Research Base

Phone: (336) 716-1048

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Arm 1: Yoga Intervention n=21 participants at risk Yoga Intervention Yoga: Yoga sessions	Arm 2: Educational Wellness Group n=17 participants at risk Educational Wellness Group Education: Educational Wellness Group
Musculoskeletal and connective tissue disorders Back Pain	23.8% 5/21 • Number of events 5 • 14 weeks Sample includes all patients with follow-up toxicity assessments. This number is different from the sample size in other analyses because some participants provided follow-up toxicity assessments before they went off study. Patients were asked about adverse events at each assessment visit.	17.6% 3/17 • Number of events 3 • 14 weeks Sample includes all patients with follow-up toxicity assessments. This number is different from the sample size in other analyses because some participants provided follow-up toxicity assessments before they went off study. Patients were asked about adverse events at each assessment visit.
General disorders Fatigue	14.3% 3/21 • Number of events 6 • 14 weeks Sample includes all patients with follow-up toxicity assessments. This number is different from the sample size in other analyses because some participants provided follow-up toxicity assessments before they went off study. Patients were asked about adverse events at each assessment visit.	11.8% 2/17 • Number of events 4 • 14 weeks Sample includes all patients with follow-up toxicity assessments. This number is different from the sample size in other analyses because some participants provided follow-up toxicity assessments before they went off study. Patients were asked about adverse events at each assessment visit.
Infections and infestations Infections and Infestations	0.00% 0/21 • 14 weeks Sample includes all patients with follow-up toxicity assessments. This number is different from the sample size in other analyses because some participants provided follow-up toxicity assessments before they went off study. Patients were asked about adverse events at each assessment visit.	5.9% 1/17 • Number of events 1 • 14 weeks Sample includes all patients with follow-up toxicity assessments. This number is different from the sample size in other analyses because some participants provided follow-up toxicity assessments before they went off study. Patients were asked about adverse events at each assessment visit.
Gastrointestinal disorders Mucositis oral	4.8% 1/21 • Number of events 2 • 14 weeks Sample includes all patients with follow-up toxicity assessments. This number is different from the sample size in other analyses because some participants provided follow-up toxicity assessments before they went off study. Patients were asked about adverse events at each assessment visit.	5.9% 1/17 • Number of events 1 • 14 weeks Sample includes all patients with follow-up toxicity assessments. This number is different from the sample size in other analyses because some participants provided follow-up toxicity assessments before they went off study. Patients were asked about adverse events at each assessment visit.
Musculoskeletal and connective tissue disorders Musculoskeletal/Soft tissue = Cartilage Tears	0.00% 0/21 • 14 weeks Sample includes all patients with follow-up toxicity assessments. This number is different from the sample size in other analyses because some participants provided follow-up toxicity assessments before they went off study. Patients were asked about adverse events at each assessment visit.	5.9% 1/17 • Number of events 1 • 14 weeks Sample includes all patients with follow-up toxicity assessments. This number is different from the sample size in other analyses because some participants provided follow-up toxicity assessments before they went off study. Patients were asked about adverse events at each assessment visit.
General disorders Myalgia	4.8% 1/21 • Number of events 1 • 14 weeks Sample includes all patients with follow-up toxicity assessments. This number is different from the sample size in other analyses because some participants provided follow-up toxicity assessments before they went off study. Patients were asked about adverse events at each assessment visit.	5.9% 1/17 • Number of events 2 • 14 weeks Sample includes all patients with follow-up toxicity assessments. This number is different from the sample size in other analyses because some participants provided follow-up toxicity assessments before they went off study. Patients were asked about adverse events at each assessment visit.
Gastrointestinal disorders Nausea	9.5% 2/21 • Number of events 3 • 14 weeks Sample includes all patients with follow-up toxicity assessments. This number is different from the sample size in other analyses because some participants provided follow-up toxicity assessments before they went off study. Patients were asked about adverse events at each assessment visit.	0.00% 0/17 • 14 weeks Sample includes all patients with follow-up toxicity assessments. This number is different from the sample size in other analyses because some participants provided follow-up toxicity assessments before they went off study. Patients were asked about adverse events at each assessment visit.
Musculoskeletal and connective tissue disorders Neck Pain	9.5% 2/21 • Number of events 3 • 14 weeks Sample includes all patients with follow-up toxicity assessments. This number is different from the sample size in other analyses because some participants provided follow-up toxicity assessments before they went off study. Patients were asked about adverse events at each assessment visit.	11.8% 2/17 • Number of events 2 • 14 weeks Sample includes all patients with follow-up toxicity assessments. This number is different from the sample size in other analyses because some participants provided follow-up toxicity assessments before they went off study. Patients were asked about adverse events at each assessment visit.
General disorders Pain	0.00% 0/21 • 14 weeks Sample includes all patients with follow-up toxicity assessments. This number is different from the sample size in other analyses because some participants provided follow-up toxicity assessments before they went off study. Patients were asked about adverse events at each assessment visit.	5.9% 1/17 • Number of events 1 • 14 weeks Sample includes all patients with follow-up toxicity assessments. This number is different from the sample size in other analyses because some participants provided follow-up toxicity assessments before they went off study. Patients were asked about adverse events at each assessment visit.
Nervous system disorders Pain in Extremity	38.1% 8/21 • Number of events 12 • 14 weeks Sample includes all patients with follow-up toxicity assessments. This number is different from the sample size in other analyses because some participants provided follow-up toxicity assessments before they went off study. Patients were asked about adverse events at each assessment visit.	23.5% 4/17 • Number of events 5 • 14 weeks Sample includes all patients with follow-up toxicity assessments. This number is different from the sample size in other analyses because some participants provided follow-up toxicity assessments before they went off study. Patients were asked about adverse events at each assessment visit.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia syndrome	0.00% 0/21 • 14 weeks Sample includes all patients with follow-up toxicity assessments. This number is different from the sample size in other analyses because some participants provided follow-up toxicity assessments before they went off study. Patients were asked about adverse events at each assessment visit.	5.9% 1/17 • Number of events 2 • 14 weeks Sample includes all patients with follow-up toxicity assessments. This number is different from the sample size in other analyses because some participants provided follow-up toxicity assessments before they went off study. Patients were asked about adverse events at each assessment visit.
Infections and infestations Peripheral nerve infection	0.00% 0/21 • 14 weeks Sample includes all patients with follow-up toxicity assessments. This number is different from the sample size in other analyses because some participants provided follow-up toxicity assessments before they went off study. Patients were asked about adverse events at each assessment visit.	5.9% 1/17 • Number of events 1 • 14 weeks Sample includes all patients with follow-up toxicity assessments. This number is different from the sample size in other analyses because some participants provided follow-up toxicity assessments before they went off study. Patients were asked about adverse events at each assessment visit.
Nervous system disorders Peripheral sensory neuropathy	9.5% 2/21 • Number of events 3 • 14 weeks Sample includes all patients with follow-up toxicity assessments. This number is different from the sample size in other analyses because some participants provided follow-up toxicity assessments before they went off study. Patients were asked about adverse events at each assessment visit.	0.00% 0/17 • 14 weeks Sample includes all patients with follow-up toxicity assessments. This number is different from the sample size in other analyses because some participants provided follow-up toxicity assessments before they went off study. Patients were asked about adverse events at each assessment visit.
Skin and subcutaneous tissue disorders Rash acneiform	9.5% 2/21 • Number of events 3 • 14 weeks Sample includes all patients with follow-up toxicity assessments. This number is different from the sample size in other analyses because some participants provided follow-up toxicity assessments before they went off study. Patients were asked about adverse events at each assessment visit.	0.00% 0/17 • 14 weeks Sample includes all patients with follow-up toxicity assessments. This number is different from the sample size in other analyses because some participants provided follow-up toxicity assessments before they went off study. Patients were asked about adverse events at each assessment visit.
Respiratory, thoracic and mediastinal disorders Sore Throat	0.00% 0/21 • 14 weeks Sample includes all patients with follow-up toxicity assessments. This number is different from the sample size in other analyses because some participants provided follow-up toxicity assessments before they went off study. Patients were asked about adverse events at each assessment visit.	5.9% 1/17 • Number of events 1 • 14 weeks Sample includes all patients with follow-up toxicity assessments. This number is different from the sample size in other analyses because some participants provided follow-up toxicity assessments before they went off study. Patients were asked about adverse events at each assessment visit.
Infections and infestations Urinary tract infection	0.00% 0/21 • 14 weeks Sample includes all patients with follow-up toxicity assessments. This number is different from the sample size in other analyses because some participants provided follow-up toxicity assessments before they went off study. Patients were asked about adverse events at each assessment visit.	5.9% 1/17 • Number of events 1 • 14 weeks Sample includes all patients with follow-up toxicity assessments. This number is different from the sample size in other analyses because some participants provided follow-up toxicity assessments before they went off study. Patients were asked about adverse events at each assessment visit.