NCT00982748

Brief Summary

The purpose of this study is to determine the feasibility and efficacy of yoga breathing techniques to manage fatigue and other cancer-related side effects, in cancer patients undergoing chemotherapy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started Oct 2008

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 18, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 23, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

August 25, 2011

Status Verified

August 1, 2011

Enrollment Period

1.2 years

First QC Date

September 18, 2009

Last Update Submit

August 23, 2011

Conditions

Breast Cancer

Keywords

FatigueChemotherapyYogaBreathingCancerAnxietyPranayamaStressFatigue-associated symptoms in chemotherapy patientsQuality of life in chemotherapy patients

Outcome Measures

Primary Outcomes (1)

  • Feasibility

    Feasibility will be evaluated based on recruitment, retention, completion of study classes and home practice, and completion of study measures

    Baseline and second cycle of chemotherapy

Secondary Outcomes (1)

  • Cancer associated symptoms and quality of life

    baseline and final cycle of chemotherapy

Study Arms (2)

Group B

ACTIVE COMPARATOR

Study participants in this arm attend yoga breathing classes once per week over the span of one chemotherapy cycle.

Behavioral: Pranayama (Yoga Breathing) Techniques

Group A

EXPERIMENTAL

Participants in this study arm attend weekly yoga breathing classes during two consecutive cycles of chemotherapy

Behavioral: Pranayama (Yoga Breathing) Techniques

Interventions

Pranayama (Yoga Breathing) TechniquesBEHAVIORAL

1-hour long yoga breathing classes, taught once per week for 2-8 consecutive weeks. Dose (Number of classes) administered is dependent on randomization arm and individuals' chemotherapy cycle length.

Group AGroup B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A diagnosis of cancer that requires at least 2 further cycles of chemotherapy on an every 14, 21, or 28 day schedule
  • A score of at least 4/10 on a 0-10 (0-none, 10-most) visual analog scale for fatigue at the time of enrollment
  • Able to read, write and understand English
  • Karnofsky Performance Status greater than 60
  • Ability to give informed consent

You may not qualify if:

  • Severe COPD
  • Receiving chronic oxygen therapy
  • Congestive heart failure: NYHA class 3 or greater
  • Transfusion dependent anemia
  • Uncontrolled thyroid disease
  • Advance kidney disease requiring dialysis
  • Advance liver disease
  • More than three previous chemotherapy regimens
  • Current, ongoing yoga breathing practice

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Osher Center for Integrative Medicine, UCSF

San Francisco, California, 94115, United States

Location

Related Publications (1)

  • Dhruva A, Miaskowski C, Abrams D, Acree M, Cooper B, Goodman S, Hecht FM. Yoga breathing for cancer chemotherapy-associated symptoms and quality of life: results of a pilot randomized controlled trial. J Altern Complement Med. 2012 May;18(5):473-9. doi: 10.1089/acm.2011.0555. Epub 2012 Apr 23.

    PMID: 22525009DERIVED

MeSH Terms

Conditions

Breast NeoplasmsFatigueRespiratory AspirationNeoplasmsAnxiety Disorders

Interventions

Methods

Condition Hierarchy (Ancestors)

Neoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsRespiration DisordersRespiratory Tract DiseasesPathologic ProcessesMental Disorders

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Clinical Professor

Study Record Dates

First Submitted

September 18, 2009

First Posted

September 23, 2009

Study Start

October 1, 2008

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

August 25, 2011

Record last verified: 2011-08

Locations

US(1)