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Yoga Therapy for Cervical Cancer
N/A
Waitlist Available
Led By Lois M Ramondetta
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Score of =< 2 on Eastern Cooperative Oncology Group (ECOG) performance scale
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 3 months post crt
Awards & highlights
Study Summary
This trial studies the effects of yoga therapy on physical and emotional well-being in patients with stage IB2-IIIB cervical cancer during chemotherapy and radiation treatment.
Who is the study for?
This trial is for English-speaking patients with stage IB2-IIIB cervical cancer who are fit enough to undergo chemotherapy and radiation (ECOG score ≤2). They must be treated at MD Anderson Cancer Center and not have had a hysterectomy, neuroendocrine histology, severe psychiatric conditions, extreme mobility issues, or a regular yoga practice recently.Check my eligibility
What is being tested?
The study examines the effectiveness of yoga therapy as an addition to standard chemotherapy and radiation in improving physical and emotional well-being. It involves exercise, meditation, breathing control during cancer treatment.See study design
What are the potential side effects?
Yoga is generally safe but may include muscle soreness or strain. Emotional side effects could arise from confronting difficult emotions during meditation. The risk of injury exists if poses are performed incorrectly.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can do most things for myself but might be unable to do heavy physical work.
Select...
My cervical cancer is stage IB2 to IIIB and I plan to have treatment aimed at curing it at MD Anderson.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline up to 3 months post crt
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 3 months post crt
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adherence to the yoga therapy protocol
Completion in the yoga therapy protocol
Yoga
Secondary outcome measures
Brief Fatigue Inventory Scale
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Group I (yoga group)Experimental Treatment5 Interventions
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.
Group II: Group II (wait list control)Active Control4 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Yoga
2008
Completed Phase 3
~3830
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,976 Previous Clinical Trials
1,789,468 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,687 Previous Clinical Trials
40,930,331 Total Patients Enrolled
Lois M RamondettaPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
32 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can do most things for myself but might be unable to do heavy physical work.I don't have health issues that would stop me from doing yoga.I have severe difficulty moving around.I have had a hysterectomy.My cancer is of neuroendocrine type.I have a health condition that prevents me from receiving full-dose chemotherapy.I have been diagnosed with another type of cancer besides the one being treated.My cervical cancer is stage IB2 to IIIB and I plan to have treatment aimed at curing it at MD Anderson.
Research Study Groups:
This trial has the following groups:- Group 1: Group I (yoga group)
- Group 2: Group II (wait list control)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the aggregate number of participants in this trial?
"Affirmative, the information stored on clinicaltrials.gov confirms that this medical experiment is actively searching for volunteers. This trial was initially posted in March of 2020 and last updated in June 2022. The researchers hope to enlist 40 people from a single location."
Answered by AI
Is this research still recruiting participants?
"Affirmative. The information on clinicaltrials.gov reflects that recruitment for this trial is proceeding actively; It was first released on March 10th 2020 and last updated June 15th 2022, with the aim of enrolling 40 individuals at a single site."
Answered by AI
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