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

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Cervical Adenocarcinoma, Cervical Adenosquamous Carcinoma, Cervical Squamous Cell Carcinoma, Not Otherwise Specified
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

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

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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:

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:

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:

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: Cervical Adenocarcinoma, Cervical Adenosquamous Carcinoma, Cervical Squamous Cell Carcinoma, Not Otherwise Specified, Stage IB2 Cervical Cancer FIGO 2018, Stage IB3 Cervical Cancer FIGO 2018, Stage II Cervical Cancer FIGO 2018
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 group	Role	What they receive
Group I (yoga group)	Experimental	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. Receives: Other: Media Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Survey Administration; Procedure: Yoga
Group II (wait list control)	Active comparator	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. 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.

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
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
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.

10 Mar 202031 Jan 2027

First posted10 Nov 2020
Study start10 Mar 2020
Primary completion31 Jan 2027 (estimated)
Study completion31 Jan 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Cervical AdenocarcinomaStudies of the same condition, open and under way.
More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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