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Cervical AdenocarcinomaNCT04622670

Yoga Therapy During Chemotherapy and Radiation Treatment for the Improvement of Physical and Emotional Well-Being in Patients With Stage IB2-IIIB Cervical Cancer

A study testing Media Intervention, Quality-of-Life Assessment and Questionnaire Administration in people with Cervical Adenocarcinoma and Cervical Adenosquamous Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This trial studies how well yoga therapy works during chemotherapy and radiation treatment in improving physical and emotional well-being in patients with stage IB2-IIIB cervical cancer. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Media Intervention, Quality-of-Life Assessment and Questionnaire Administration
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited States
Study dates
10 Mar 2020to 31 Jan 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Score of =< 2 on Eastern Cooperative Oncology Group (ECOG) performance scale
  • 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

Who cannot join

  • Medically documented restrictions at enrollment that could interfere with participation in the yoga interventions (i.e. uncontrolled vaginal bleeding)
  • Medical illness that would prevent administration of full-dose chemotherapy
  • Concurrent diagnosis of a second cancer
  • Prior hysterectomy
  • Neuroendocrine histology
  • Patients who are pregnant
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • M D Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: Yoga Therapy During Chemotherapy and Radiation Treatment for Local-Regional Cervical Cancer

This trial studies how well yoga therapy works during chemotherapy and radiation treatment in improving physical and emotional well-being in patients with stage IB2-IIIB cervical cancer. Yoga therapy may help to balance the mind and body through exercise, meditation (focusing thoughts), and control of breathing and emotions.

Read the detailed description

PRIMARY OBJECTIVE:

  1. 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:

  1. 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:

  1. 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.

Being tested
Media Intervention, Quality-of-Life Assessment, Questionnaire Administration, Survey Administration, Yoga

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Media InterventionOther

    Receive DVD

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Ancillary studies

  • Questionnaire AdministrationOther

    Ancillary studies

  • Survey AdministrationOther

    Ancillary studies

  • YogaProcedure or surgery

    Also called Yoga Therapy

    Attend yoga class

Study groups in NCT04622670
Study groupRoleWhat they receive
Group I (yoga group)ExperimentalPatients 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.
Receives: Other: Media Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Survey Administration; Procedure: Yoga
Group II (wait list control)Active comparatorPatients 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.
Receives: Other: Media Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Survey Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Enrollment to the yoga therapy protocol

    90 patients will be screen to obtain at least 40 who are eligible and consent

    Measured: Baseline up to 3 months post CRT

  2. Adherence to the yoga therapy protocol

    At least 10 patients in the YG group must complete at least 50% of the required yoga sessions

    Measured: Baseline up to 3 months post CRT

  3. Completion in the yoga therapy protocol

    At least 25 of the 40 patients must complete any of the follow up measure between T3 and T5 in order to declare this study feasible

    Measured: Baseline up to 3 months post CRT

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Nov 2020
  2. Study start10 Mar 2020
  3. Primary completion31 Jan 2027 (estimated)
  4. Study completion31 Jan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04622670
Sponsor's protocol ID
2019-0919
Other IDs
NCI-2020-02021, 2019-0919
Status last verified
Jul 2026
First submitted
30 Apr 2020
Last updated
16 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Media Intervention, Quality-of-Life Assessment and Questionnaire Administration in people with Cervical Adenocarcinoma and Cervical Adenosquamous Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Enrollment to the yoga therapy protocol (time frame: Baseline up to 3 months post CRT). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04622670.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.

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