Clinical trial NCT04622670: Yoga Therapy During Chemotherapy and Radiation Treatment for the Improvement of Physical and Emotional Well-Being in Patients With Stage IB2-IIIB Cervical Cancer
Official title: Yoga Therapy During Chemotherapy and Radiation Treatment for Local-Regional Cervical Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
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
Stage IIA Cervical Cancer FIGO 2018
Stage IIA1 Cervical Cancer FIGO 2018
Stage IIA2 Cervical Cancer FIGO 2018
Stage IIB Cervical Cancer FIGO 2018
Stage IIIA Cervical Cancer FIGO 2018
Stage IIIB Cervical Cancer FIGO 2018
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-11-10
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: PRIMARY OBJECTIVE:

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Enrollment to the yoga therapy protocol
timeFrame: Baseline up to 3 months post CRT
measure: Adherence to the yoga therapy protocol
timeFrame: Baseline up to 3 months post CRT
measure: Completion in the yoga therapy protocol
timeFrame: Baseline up to 3 months post CRT
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Lois M Ramondetta, MD
role: PRINCIPAL_INVESTIGATOR
References: