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Acupressure for Fatigue in Ovarian Cancer Survivors
N/A
Recruiting
Led By Suzanna M Zick, ND, MPH
Research Sponsored by University of Michigan Rogel Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have average persistent fatigue defined a >=4 on the Brief Fatigue Inventory at least 50% of their days for at least 3 months
Fatigue must have started at or after the diagnosis of ovarian cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to week 24
Awards & highlights
Study Summary
This trial is testing whether accupressure can help reduce fatigue in ovarian cancer patients.
Who is the study for?
This trial is for women over 21 who have had ovarian cancer and are experiencing fatigue that started after their diagnosis. They must have finished primary treatments like surgery or chemo at least 6 months ago but can be on maintenance therapies. Participants should not be anemic, recently treated with acupressure or acupuncture, have untreated hypothyroidism or mood disorders, nor plan to change any current medications.Check my eligibility
What is being tested?
The study tests if acupressure can alleviate fatigue in ovarian cancer survivors. It compares the effects of actual acupressure against sham (fake) acupressure and standard care without additional interventions for fatigue. Acupressure involves applying pressure to specific body points with fingers or a device.See study design
What are the potential side effects?
Acupressure is generally considered safe but may cause minor side effects such as soreness at the pressure points, bruising, or feeling lightheaded. Since it's non-invasive, serious side effects are rare.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have felt very tired on most days for the last 3 months.
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My fatigue began after my ovarian cancer diagnosis.
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I am not planning any new treatments for fatigue besides my current medications.
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I have been diagnosed with ovarian cancer at any stage.
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I finished my main cancer treatments over 6 months ago, except for ongoing maintenance.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline up to week 24
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to week 24
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in level of fatigue at week 6
Change in level of fatigue up to week 24
Secondary outcome measures
Change in quality of life at week 6
Change in quality of life up to week 24
Change in sleep quality at week 6
+1 moreTrial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Standard of careExperimental Treatment1 Intervention
Participants will receive standard of care only.
Group II: Acupressure plus standard of careExperimental Treatment2 Interventions
Using AcuWand, participants will apply acupressure to points that are known to affect physiology. Participants will also receive standard of care.
Group III: Sham acupressure plus standard of carePlacebo Group2 Interventions
Using AcuWand, participants will apply acupressure to points that are not known to affect physiology. Participants will also receive standard of care.
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Who is running the clinical trial?
University of Michigan Rogel Cancer CenterLead Sponsor
293 Previous Clinical Trials
23,932 Total Patients Enrolled
4 Trials studying Ovarian Cancer
1,022 Patients Enrolled for Ovarian Cancer
Suzanna M Zick, ND, MPHPrincipal InvestigatorUniversity of Michigan
9 Previous Clinical Trials
747 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have felt very tired on most days for the last 3 months.You are capable of getting pregnant.I am not planning any new treatments for fatigue besides my current medications.I have been diagnosed with a mood disorder like bipolar or depression but haven't received treatment.I am a woman aged 21 or older.I have been diagnosed with ovarian cancer at any stage.You are not in good health and have ongoing medical issues.I have been diagnosed with anemia.I have received acupuncture or acupressure in the last year.I have been diagnosed with hypothyroidism and have not started treatment.I am not planning to change my current medications or therapies during the study.My fatigue began after my ovarian cancer diagnosis.I finished my main cancer treatments over 6 months ago, except for ongoing maintenance.
Research Study Groups:
This trial has the following groups:- Group 1: Sham acupressure plus standard of care
- Group 2: Acupressure plus standard of care
- Group 3: Standard of care
Awards:
This trial has 0 awards, including: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 are the central aims of this clinical experiment?
"This research project, which will be tracked over a period of 24 weeks starting with baseline measurements, aims to observe the shift in fatigue levels after 6 weeks. Secondary objectives include gauging changes in quality of life (via FACT-O), sleep quality at week 6 and week 24 (based on PSQI scores)."
Answered by AI
Are new patients able to join this clinical investigation?
"Absolutely. According to clinicaltrials.gov, the study is currently recruiting individuals for participation and was originally posted on October 7th 2019 before being amended most recently on November 1st 2022. This research requires 165 enrollees from a single medical hub."
Answered by AI
What is the aggregate number of individuals currently enrolled in this medical experiment?
"Affirmative. Clinicaltrials.gov has the most up-to-date information which states that this research, which was originally posted on October 7th 2019, is actively recruiting 165 participants from one centre."
Answered by AI
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