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Acupressure for Fatigue in Ovarian Cancer Survivors

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ClinicalTrials.gov Identifier: NCT03763838
Recruitment Status : Not yet recruiting
First Posted : December 4, 2018
Last Update Posted : December 4, 2018
Sponsor:
Information provided by (Responsible Party):
University of Michigan Cancer Center

Brief Summary:
The purpose of this study is to see if accupressure can help reduce the severity of fatigue experienced by ovarian cancer patients. Acupressure involves applying mild to moderate physical pressure by fingers, hand or a device to specific points on the skin to try to bring about a change in the body's functioning, in this case relief from chronic fatigue.

Condition or disease Intervention/treatment Phase
Fatigue Ovarian Cancer Other: Acupressure Other: Sham acupressure Other: Standard of Care Not Applicable

Study Type : Interventional
Estimated Enrollment : 165 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Participants in the "standard of care" arm will not be blinded; however, the two self-acupressure arms will be blinded as to which acupressure treatment they have been randomized. All study staff and researchers will remain blinded until after the completion of data analyses.
Primary Purpose: Supportive Care
Official Title: Acupressure for Fatigue in Ovarian Cancer Survivors
Estimated Study Start Date : January 15, 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021


Arm Intervention/treatment
Experimental: Acupressure plus standard of care
Using AcuWand, participants will apply acupressure to points that are known to affect physiology. Participants will also receive standard of care.
Other: Acupressure
Six weeks of daily self-administered relaxing acupressure. Instructions will be provided for how to perform acupressure on self. A tool (AcuWand) will be provided to help participants apply the right amount of pressure on the appropriate points on their bodies. These are points that are recognized as effective in Traditional Chinese Medicine (TCM).

Other: Standard of Care
Fatigue management provided by participants' health care providers.

Sham Comparator: Sham acupressure plus standard of care
Using AcuWand, participants will apply acupressure to points that are not known to affect physiology. Participants will also receive standard of care.
Other: Sham acupressure
Six weeks of daily self-administered sham acupressure. Instructions will be provided for how to perform acupressure on self. A tool (AcuWand) will be provided to help participants apply the right amount of pressure; however, the points that participants are instructed to use are not known to have any effect on the body.

Other: Standard of Care
Fatigue management provided by participants' health care providers.

Standard of care
Participants will receive standard of care only.
Other: Standard of Care
Fatigue management provided by participants' health care providers.




Primary Outcome Measures :
  1. Change in level of fatigue at week 6 [ Time Frame: Baseline to week 6 ]
    Self-reported on the Brief Fatigue Inventory (BFI)

  2. Change in level of fatigue up to week 24 [ Time Frame: Baseline up to week 24 ]
    Self-reported on the Brief Fatigue Inventory (BFI)


Secondary Outcome Measures :
  1. Change in quality of life at week 6 [ Time Frame: Baseline to week 6 ]
    Self-reported on the Functional Assessment of Cancer Therapy Ovarian (FACT-O)

  2. Change in quality of life up to week 24 [ Time Frame: Baseline up to week 24 ]
    Self-reported on the Functional Assessment of Cancer Therapy Ovarian (FACT-O)

  3. Change in sleep quality at week 6 [ Time Frame: Baseline to week 6 ]
    Self-reported on the Pittsburgh Sleep Quality Index (PSQI)

  4. Change in sleep quality up to week 24 [ Time Frame: Baseline up to week 24 ]
    Self-reported on the Pittsburgh Sleep Quality Index (PSQI)



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women aged 21 and older
  • Diagnosis of clear-cell, endometrioid or high grade serous ovarian cancer, stages I to IV within the last 2 years
  • 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
  • Completed all primary cancer treatments (surgery, chemotherapy at least 6 months prior)
  • Have no evidence of ovarian cancer disease progression
  • No other planned interventions for fatigue other than current stable medication

Exclusion Criteria:

  • Medically unstable
  • Acupuncture or acupressure receipt in past year
  • Have a diagnosis of untreated mood disorder, e.g., bipolar or major depressive disorder
  • Have a current diagnosis of anemia
  • Have a current untreated diagnosis of hypothyroidism
  • Have an initiation, a cessation or change of treatment of any chronic medications, dietary supplements, behavioral therapy, physical therapy, etc., or any planned change of medications, supplements or therapies during the study
  • Have the possibility of becoming pregnant

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03763838


Contacts
Contact: Suzanna M Zick, ND, MPH 734-998-9553 szick@umich.edu

Sponsors and Collaborators
University of Michigan Cancer Center
Investigators
Principal Investigator: Suzanna M Zick, ND, MPH University of Michigan

Responsible Party: University of Michigan Cancer Center
ClinicalTrials.gov Identifier: NCT03763838     History of Changes
Other Study ID Numbers: UMCC 2018.130
HUM00143509 ( Other Identifier: University of Michigan )
First Posted: December 4, 2018    Key Record Dates
Last Update Posted: December 4, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Michigan Cancer Center:
Acupressure

Additional relevant MeSH terms:
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Fatigue
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms by Histologic Type
Signs and Symptoms