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

NCT04622670 | Active Not Recruiting

• 2 other identifiers: 2019-0919NCI-2020-02021
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. Yoga therapy may help to balance the mind and body through exercise, meditation (focusing thoughts), and control of breathing and emotions.

Conditions

Cervical Adenocarcinoma; Stage IB2 Cervical Cancer FIGO 2018; Stage IB3 Cervical Cancer FIGO 2018; Stage IIA Cervical Cancer FIGO 2018; Stage IIA1 Cervical Cancer FIGO 2018; Stage IIA2 Cervical Cancer FIGO 2018; Stage IIIA Cervical Cancer FIGO 2018; Cervical Adenosquamous Carcinoma; Cervical Squamous Cell Carcinoma, Not Otherwise Specified; Stage II Cervical Cancer FIGO 2018; Stage IIB Cervical Cancer FIGO 2018; Stage IIIB Cervical Cancer FIGO 2018

Outcome Measures

Primary Outcomes (3)

• Enrollment to the yoga therapy protocol

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

  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

  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

  Baseline up to 3 months post CRT

Study Arms (2)

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.

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.

Other: Media Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Survey Administration

Interventions

Media Intervention OTHER

Receive DVD

Group I (yoga group); Group II (wait list control)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Group I (yoga group); Group II (wait list control)

Questionnaire Administration OTHER

Ancillary studies

Group I (yoga group); Group II (wait list control)

Survey Administration OTHER

Ancillary studies

Group I (yoga group); Group II (wait list control)

Yoga PROCEDURE

Attend yoga class

Also known as: Yoga Therapy

Group I (yoga group)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer

MeSH Terms

Interventions

Yoga

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Lois M Ramondetta, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2020
• First Posted: November 10, 2020
• Study Start: March 10, 2020
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027
• Last Updated: January 20, 2026

Record last verified: 2026-01

Locations

US (1)