search
Back to results

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

Primary Purpose

Cervical Adenocarcinoma, Cervical Adenosquamous Carcinoma, Cervical Squamous Cell Carcinoma, Not Otherwise Specified

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Media Intervention
Quality-of-Life Assessment
Questionnaire Administration
Survey Administration
Yoga
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cervical Adenocarcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • M D Anderson Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group I (yoga group)

Group II (wait list control)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Enrollment to the yoga therapy protocol
90 patients will be screen to obtain at least 40 who are eligible and consent
Adherence to the yoga therapy protocol
At least 10 patients in the YG group must complete at least 50% of the required yoga sessions
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

Secondary Outcome Measures

Full Information

First Posted
April 30, 2020
Last Updated
May 11, 2023
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT04622670
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 10, 2020 (Actual)
Primary Completion Date
January 3, 2024 (Anticipated)
Study Completion Date
January 3, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group I (yoga group)
Arm Type
Experimental
Arm Description
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.
Arm Title
Group II (wait list control)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Media Intervention
Intervention Description
Receive DVD
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Survey Administration
Intervention Description
Ancillary studies
Intervention Type
Procedure
Intervention Name(s)
Yoga
Other Intervention Name(s)
Yoga Therapy
Intervention Description
Attend yoga class
Primary Outcome Measure Information:
Title
Enrollment to the yoga therapy protocol
Description
90 patients will be screen to obtain at least 40 who are eligible and consent
Time Frame
Baseline up to 3 months post CRT
Title
Adherence to the yoga therapy protocol
Description
At least 10 patients in the YG group must complete at least 50% of the required yoga sessions
Time Frame
Baseline up to 3 months post CRT
Title
Completion in the yoga therapy protocol
Description
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
Time Frame
Baseline up to 3 months post CRT

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Donna Griffin
Phone
832-696-6643
Email
DKGriffin@mdanderson.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lois M Ramondetta, MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Donna Griffin, MD
Phone
832-696-6643
Email
DKGriffin@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Lois M Ramondetta, MD

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
MD Anderson Cancer

Learn more about this trial

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

We'll reach out to this number within 24 hrs