Yoga Therapy During Chemotherapy and Radiation Treatment for the Improvement of Physical and Emotional Well-Being in Patients With Stage IB2-IIIB Cervical Cancer
NCT ID: NCT04622670
Last Updated: 2026-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
40 participants
INTERVENTIONAL
2020-03-10
2027-01-31
Brief Summary
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Detailed Description
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I. Establish feasibility of delivering a yoga therapy program during chemotherapy and radiation therapy (CRT) for loco-regionally advanced cervical cancer undergoing chemo-radiotherapy.
SECONDARY OBJECTIVES:
I. Measure the effects and variance of yoga on fatigue, depression, anxiety, pelvic pain and over-all quality of life (QOL) in cervical cancer (CxCa) patients undergoing primary treatment with CRT.
II. Examine changes in other psychosocial outcomes including ability to find meaning in the illness, spirituality and sexuality.
EXPLORATORY OBJECTIVE:
I. Evaluate whether markers of stress response (plasma levels of other pro-inflammatory cytokines, including interleukin-6 \[IL-6\], and IL-8, IL-10, VEGF, and CRP) change in response to yoga therapy and their association with fatigue, depression, anxiety, pelvic pain, meaning in the illness, experience, spirituality, and QOL in CxCa patients undergoing primary CRT.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I (YOGA GROUP): Patients attend at least 2 yoga classes per week over 5-6 weeks lasting approximately 60 minutes each for up to 15 classes during the CRT. Patients also complete surveys pre-treatment, once a week, and post-treatment and receive a yoga manual and DVD during and after CRT.
GROUP II (WAIT LIST CONTROL): Patients refrain from participating in any new stress management activities and receive a DVD. Patients are also offered 4 group yoga classes after 3 months of CRT. Patients also complete surveys as in Group I.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Group I (yoga group)
Patients attend at least 2 yoga classes per week over 5-6 weeks lasting approximately 60 minutes each for up to 15 classes during the CRT. Patients also complete surveys pre-treatment, once a week, and post-treatment over and receive a yoga manual and DVD during and after CRT.
Media Intervention
Receive DVD
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Survey Administration
Ancillary studies
Yoga
Attend yoga class
Group II (wait list control)
Patients refrain from participating in any new stress management activities and receive a DVD. Patients are also offered 4 group yoga classes after 3 months of CRT. Patients also complete surveys as in Group I.
Media Intervention
Receive DVD
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Survey Administration
Ancillary studies
Interventions
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Media Intervention
Receive DVD
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Survey Administration
Ancillary studies
Yoga
Attend yoga class
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Able to speak English
* Federation of Gynecology and Obstetrics (FIGO) stage IB2 through IIIB biopsy-proven CxCa (adenocarcinoma, squamous cell carcinoma, and adenosquamous) with plan to undergo curative outpatient CRT at main campus MD Anderson Cancer Center
Exclusion Criteria
* Medical illness that would prevent administration of full-dose chemotherapy
* Concurrent diagnosis of a second cancer
* Prior hysterectomy
* Neuroendocrine histology
* Patients who are pregnant
* It is standard procedure to administer a pregnancy test before the start of CRT. Patients are deemed not pregnant by virtue of urine pregnancy test (UPT) or testing of the blood. Due to radiation and the nature of the disease, a patient becoming pregnant while on study is highly unlikely. In the event a patient were to get pregnant, they would be removed from study because their radiation therapy (RT) might be stopped or fetus would be terminated, which might influence other parameters that are being measured
* Patients with major psychiatric diagnoses (e.g., schizophrenia, bipolar disorder)
* Patients with extreme mobility issues, and
* Patients who have had a regular yoga practice (at least one time a month) in past 6 months prior to study enrollment or who are currently engaged in a regular mind-body practice
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Lois M Ramondetta, MD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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Provided Documents
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Document Type: Informed Consent Form
Related Links
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MD Anderson Cancer
Other Identifiers
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NCI-2020-02021
Identifier Type: REGISTRY
Identifier Source: secondary_id
2019-0919
Identifier Type: OTHER
Identifier Source: secondary_id
2019-0919
Identifier Type: -
Identifier Source: org_study_id
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