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

Trial Status: Active

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.

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

Texas

Houston
M D Anderson Cancer Center
Status: ACTIVE
Contact: Linda Dao
Phone: 713-563-4547

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 yoga instruction materials (such as a manual and video via electronic link or physical medium) during and after CRT.

GROUP II (WAIT LIST CONTROL): Patients refrain from participating in any new stress management activities and receive yoga instruction materials (such as a manual and video via electronic link or physical medium). Patients are also offered 4 group yoga classes 3 months after CRT. Patients also complete surveys as in Group I.

Trial Phase Phase NA

Trial Type Supportive care

Lead Organization
M D Anderson Cancer Center

Principal Investigator
Lois M. Ramondetta

  • Primary ID 2019-0919
  • Secondary IDs NCI-2020-02021
  • Clinicaltrials.gov ID NCT04622670