Iyengar Yoga for Chemotherapy-induced Fatigue in Breast Cancer Patients

NCT ID: NCT01686737

Last Updated: 2013-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2014-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Breast cancer is the most frequent cancer in women and is associated with profound restrictions of health-related quality of life and psychosocial health. More than three-quarters of women with breast cancer suffer from fatigue during cancer treatment. While exercise interventions can improve fatigue in breast cancer patients, many patients request complementary treatment approaches. Therefore, this study investigates the effects of yoga in women with breast cancer compared to aerobic exercise and usual care.

It is hypothesized that yoga is more effective than usual care and equally effective as aerobic exercise.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Neoplasms Fatigue

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Yoga

Iyengar Yoga

* 12 weeks of Iyengar yoga
* 2 weekly sessions of 60 minutes

Group Type EXPERIMENTAL

Iyengar Yoga

Intervention Type BEHAVIORAL

* 12 weeks of Iyengar yoga
* 2 weekly sessions of 60 minutes

Aerobic exercise

Walking

* 12 weeks of walking
* 2 weekly sessions of 60 minutes

Group Type ACTIVE_COMPARATOR

Walking

Intervention Type BEHAVIORAL

* 12 weeks of walking
* 2 weekly sessions of 60 minutes

Usual Care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Iyengar Yoga

* 12 weeks of Iyengar yoga
* 2 weekly sessions of 60 minutes

Intervention Type BEHAVIORAL

Walking

* 12 weeks of walking
* 2 weekly sessions of 60 minutes

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* non-metastatic invasive breast cancer
* currently receiving adjuvant chemotherapy
* moderate to severe chemotherapy-induced fatigue
* physical and cognitive capacity to participate in yoga or walking

Exclusion Criteria

* diagnosed and pharmacologically treated psychiatric disorder except depressive adaptation disorder as a reaction to cancer diagnosis
* ECOG status \> 1
* prior malignancy with a disease-free survival \< 10 years except curatively treated basalioma of the skin and carcinoma in situ of the cervix
* prior ductal carcinoma in situ (DCIS) ot the breast
* pregnancy or breastfeeding
* regular practice of yoga or walking during the past 12 months
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Universität Duisburg-Essen

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Holger Cramer

Postdoctoral fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Holger Cramer, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Duisburg-Essen, Chair of Complementary and Integrative Medicine

Gustav J. Dobos, MD

Role: STUDY_DIRECTOR

University of Duisburg-Essen, Chair of Complementary and Integrative Medicine

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Brustzentrum Köln-Hohenlind, St. Elisabeth-Krankenhaus Köln-Hohenlind

Cologne, , Germany

Site Status

Klinik für Senologie / Brustzentrum, Kliniken Essen-Mitte

Essen, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2012210

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Yoga During Chemotherapy Study
NCT02442635 COMPLETED NA
Yoga Fatigue Study
NCT02134782 TERMINATED NA
Effects of Yoga on Children With Cancer
NCT06651918 NOT_YET_RECRUITING NA