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An AHEI Dietary Intervention to Reduce Pain in Women With Endometriosis

Primary Purpose

Endometriosis

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AHEI diet
Sponsored by
Fred Hutchinson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometriosis focused on measuring Diet

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Female
  • Aged 18-45
  • Laparoscopically-confirmed endometriosis
  • Premenopausal (at least one period in the past 6 months)
  • VAS pain score of at least 7 out of 10 in the previous 3 months
  • Score below 75 on the AHEI-2010

Exclusion Criteria:

  • Postmenopausal
  • Pregnant
  • Have had a hysterectomy or oophorectomy
  • Have chronic illnesses that are known to affect gastrointestinal absorption of nutrients (celiac disease, Crohn's disease, ulcerative colitis, or cystic fibrosis)
  • A history of kidney stones, cancer (except basal cell carcinoma), or diabetes

Sites / Locations

  • Fred Hutchinson Cancer Research CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

The intervention group will receive in-person dietary counseling from a registered dietitian to help participants consume a diet that is consistent the AHEI dietary guidelines. Participants in this arm will be asked to consume this diet for a 12-week period and discontinue any vitamin or supplement intake during this time. During the first 4 weeks 2 meals and 1 snack/day will be shipped to the participant. During the last 8 weeks of the intervention, the study will provide the participants with a 14-day meal plan (3 meals and 2 snacks) that adheres to the AHEI maximum score criteria to help facilitate adherence to the diet.

Participants in this arm will not receive the dietary intervention.

Outcomes

Primary Outcome Measures

Pain Measurement
Pain will be measured with components of the EPHect participant questionnaire using the VAS pain score. Scores range from 0 to 10, higher score is more pain (worse).
Pain Measurement
Pain will be measured with components of the EPHect participant questionnaire using the pain catastrophizing scale. Scores range from 0 to 52, higher scores indicate a greater amount of catastrophizing (worse).
Pain Measurement
Pain will be measured with components of the EPHect participant questionnaire using the mean number of analgesic and/or opioid pills taken per week.
Quality of Life Questionnaire
Physical and mental QOL components will be measured with the Endometriosis Health Profile Questionnaire. Scores range from 0 to 100, higher scores reflect more symptoms and worse health status.
Quality of Life Survey
Physical and mental QOL components will be measured with the Short Form-12 survey. There are two components, a physical component summary (PCS) and a mental health component summary (MCS). Both have a range of 0 to 100, higher scores represent better health.
Inflammatory Markers
Measurement of circulating levels of inflammatory markers (interleukin (IL)-6 and IL-1β.
Protein Measurement
Measurement of circulating levels of high sensitivity-C-reactive protein.
Tumor Necrosis Factor Measurement
Measurement of circulating levels of soluble tumor necrosis factor (TNF) alpha-receptor 1.
Tumor Necrosis Factor Measurement #2
Measurement of circulating levels of soluble TNF alpha-receptor 2.
Pain Measurement
Pain will be measured with components of the EPHect participant questionnaire using the VAS pain score. Scores range from 0 to 10, higher score is more pain (worse).
Pain Measurement
Pain will be measured with components of the EPHect participant questionnaire using the pain catastrophizing scale. Scores range from 0 to 52, higher scores indicate a greater amount of catastrophizing (worse).
Pain Measurement
Pain will be measured with components of the EPHect participant questionnaire using the mean number of analgesic and/or opioid pills taken per week.
Quality of Life Questionnaire
Physical and mental QOL components will be measured with the Endometriosis Health Profile Questionnaire. Scores range from 0 to 100, higher scores reflect more symptoms and worse health status.
Quality of Life Survey
Physical and mental QOL components will be measured with the Short Form-12 survey. There are two components, a physical component summary (PCS) and a mental health component summary (MCS). Both have a range of 0 to 100, higher scores represent better health.
Inflammatory Markers
Measurement of circulating levels of inflammatory markers (interleukin (IL)-6 and IL-1β.
Protein Measurement
Measurement of circulating levels of high sensitivity-C-reactive protein.
Tumor Necrosis Factor Measurement
Measurement of circulating levels of soluble tumor necrosis factor (TNF) alpha-receptor 1.
Tumor Necrosis Factor Measurement #2
Measurement of circulating levels of soluble TNF alpha-receptor 2.
Pain Measurement
Pain will be measured with components of the EPHect participant questionnaire using the VAS pain score. Scores range from 0 to 10, higher score is more pain (worse).
Pain Measurement
Pain will be measured with components of the EPHect participant questionnaire using the pain catastrophizing scale. Scores range from 0 to 52, higher scores indicate a greater amount of catastrophizing (worse).
Pain Measurement
Pain will be measured with components of the EPHect participant questionnaire using the mean number of analgesic and/or opioid pills taken per week.
Quality of Life Questionnaire
Physical and mental QOL components will be measured with the Endometriosis Health Profile Questionnaire. Scores range from 0 to 100, higher scores reflect more symptoms and worse health status.
Quality of Life Survey
Physical and mental QOL components will be measured with the Short Form-12 survey. There are two components, a physical component summary (PCS) and a mental health component summary (MCS). Both have a range of 0 to 100, higher scores represent better health.
Inflammatory Markers
Measurement of circulating levels of inflammatory markers (interleukin (IL)-6 and IL-1β.
Protein Measurement
Measurement of circulating levels of high sensitivity-C-reactive protein.
Tumor Necrosis Factor Measurement
Measurement of circulating levels of soluble tumor necrosis factor (TNF) alpha-receptor 1.
Tumor Necrosis Factor Measurement #2
Measurement of circulating levels of soluble TNF alpha-receptor 2.
Pain Measurement
Pain will be measured with components of the EPHect participant questionnaire using the VAS pain score. Scores range from 0 to 10, higher score is more pain (worse).
Pain Measurement
Pain will be measured with components of the EPHect participant questionnaire using the pain catastrophizing scale. Scores range from 0 to 52, higher scores indicate a greater amount of catastrophizing (worse).
Pain Measurement
Pain will be measured with components of the EPHect participant questionnaire using the mean number of analgesic and/or opioid pills taken per week.
Quality of Life Questionnaire
Physical and mental QOL components will be measured with the Endometriosis Health Profile Questionnaire. Scores range from 0 to 100, higher scores reflect more symptoms and worse health status.
Quality of Life Survey
Physical and mental QOL components will be measured with the Short Form-12 survey. There are two components, a physical component summary (PCS) and a mental health component summary (MCS). Both have a range of 0 to 100, higher scores represent better health.
inflammatory Markers
Measurement of circulating levels of inflammatory markers (interleukin (IL)-6 and IL-1β.
Protein Measurement
Measurement of circulating levels of high sensitivity-C-reactive protein.
Tumor Necrosis Factor Measurement
Measurement of circulating levels of soluble tumor necrosis factor (TNF) alpha-receptor 1.
Tumor Necrosis Factor Measurement #2
Measurement of circulating levels of soluble TNF alpha-receptor 2.

Secondary Outcome Measures

Full Information

First Posted
January 9, 2020
Last Updated
September 25, 2023
Sponsor
Fred Hutchinson Cancer Center
Collaborators
National Institute of Nursing Research (NINR)
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1. Study Identification

Unique Protocol Identification Number
NCT04259788
Brief Title
An AHEI Dietary Intervention to Reduce Pain in Women With Endometriosis
Official Title
An AHEI Dietary Intervention to Reduce Pain in Women With Endometriosis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 24, 2021 (Actual)
Primary Completion Date
January 31, 2025 (Anticipated)
Study Completion Date
January 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fred Hutchinson Cancer Center
Collaborators
National Institute of Nursing Research (NINR)

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
The investigators are conducting this study to examine if a healthy diet based on the Alternative Healthy Eating Index (AHEI) influences pain symptoms, quality of life, and inflammatory markers measured in blood samples in women with endometriosis who are currently experiencing pain symptoms.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
The intervention group will receive in-person dietary counseling from a registered dietitian to help participants consume a diet that is consistent the AHEI dietary guidelines. Participants in this arm will be asked to consume this diet for a 12-week period and discontinue any vitamin or supplement intake during this time. During the first 4 weeks 2 meals and 1 snack/day will be shipped to the participant. During the last 8 weeks of the intervention, the study will provide the participants with a 14-day meal plan (3 meals and 2 snacks) that adheres to the AHEI maximum score criteria to help facilitate adherence to the diet.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants in this arm will not receive the dietary intervention.
Intervention Type
Other
Intervention Name(s)
AHEI diet
Intervention Description
Main intervention is the consumption of an AHEI diet for 12 weeks.
Primary Outcome Measure Information:
Title
Pain Measurement
Description
Pain will be measured with components of the EPHect participant questionnaire using the VAS pain score. Scores range from 0 to 10, higher score is more pain (worse).
Time Frame
Baseline
Title
Pain Measurement
Description
Pain will be measured with components of the EPHect participant questionnaire using the pain catastrophizing scale. Scores range from 0 to 52, higher scores indicate a greater amount of catastrophizing (worse).
Time Frame
Baseline
Title
Pain Measurement
Description
Pain will be measured with components of the EPHect participant questionnaire using the mean number of analgesic and/or opioid pills taken per week.
Time Frame
Baseline
Title
Quality of Life Questionnaire
Description
Physical and mental QOL components will be measured with the Endometriosis Health Profile Questionnaire. Scores range from 0 to 100, higher scores reflect more symptoms and worse health status.
Time Frame
Baseline
Title
Quality of Life Survey
Description
Physical and mental QOL components will be measured with the Short Form-12 survey. There are two components, a physical component summary (PCS) and a mental health component summary (MCS). Both have a range of 0 to 100, higher scores represent better health.
Time Frame
Baseline
Title
Inflammatory Markers
Description
Measurement of circulating levels of inflammatory markers (interleukin (IL)-6 and IL-1β.
Time Frame
Baseline
Title
Protein Measurement
Description
Measurement of circulating levels of high sensitivity-C-reactive protein.
Time Frame
Baseline
Title
Tumor Necrosis Factor Measurement
Description
Measurement of circulating levels of soluble tumor necrosis factor (TNF) alpha-receptor 1.
Time Frame
Baseline
Title
Tumor Necrosis Factor Measurement #2
Description
Measurement of circulating levels of soluble TNF alpha-receptor 2.
Time Frame
Baseline
Title
Pain Measurement
Description
Pain will be measured with components of the EPHect participant questionnaire using the VAS pain score. Scores range from 0 to 10, higher score is more pain (worse).
Time Frame
Week 4
Title
Pain Measurement
Description
Pain will be measured with components of the EPHect participant questionnaire using the pain catastrophizing scale. Scores range from 0 to 52, higher scores indicate a greater amount of catastrophizing (worse).
Time Frame
Week 4
Title
Pain Measurement
Description
Pain will be measured with components of the EPHect participant questionnaire using the mean number of analgesic and/or opioid pills taken per week.
Time Frame
Week 4
Title
Quality of Life Questionnaire
Description
Physical and mental QOL components will be measured with the Endometriosis Health Profile Questionnaire. Scores range from 0 to 100, higher scores reflect more symptoms and worse health status.
Time Frame
Week 4
Title
Quality of Life Survey
Description
Physical and mental QOL components will be measured with the Short Form-12 survey. There are two components, a physical component summary (PCS) and a mental health component summary (MCS). Both have a range of 0 to 100, higher scores represent better health.
Time Frame
Week 4
Title
Inflammatory Markers
Description
Measurement of circulating levels of inflammatory markers (interleukin (IL)-6 and IL-1β.
Time Frame
Week 4
Title
Protein Measurement
Description
Measurement of circulating levels of high sensitivity-C-reactive protein.
Time Frame
Week 4
Title
Tumor Necrosis Factor Measurement
Description
Measurement of circulating levels of soluble tumor necrosis factor (TNF) alpha-receptor 1.
Time Frame
Week 4
Title
Tumor Necrosis Factor Measurement #2
Description
Measurement of circulating levels of soluble TNF alpha-receptor 2.
Time Frame
Week 4
Title
Pain Measurement
Description
Pain will be measured with components of the EPHect participant questionnaire using the VAS pain score. Scores range from 0 to 10, higher score is more pain (worse).
Time Frame
Week 8
Title
Pain Measurement
Description
Pain will be measured with components of the EPHect participant questionnaire using the pain catastrophizing scale. Scores range from 0 to 52, higher scores indicate a greater amount of catastrophizing (worse).
Time Frame
Week 8
Title
Pain Measurement
Description
Pain will be measured with components of the EPHect participant questionnaire using the mean number of analgesic and/or opioid pills taken per week.
Time Frame
Week 8
Title
Quality of Life Questionnaire
Description
Physical and mental QOL components will be measured with the Endometriosis Health Profile Questionnaire. Scores range from 0 to 100, higher scores reflect more symptoms and worse health status.
Time Frame
Week 8
Title
Quality of Life Survey
Description
Physical and mental QOL components will be measured with the Short Form-12 survey. There are two components, a physical component summary (PCS) and a mental health component summary (MCS). Both have a range of 0 to 100, higher scores represent better health.
Time Frame
Week 8
Title
Inflammatory Markers
Description
Measurement of circulating levels of inflammatory markers (interleukin (IL)-6 and IL-1β.
Time Frame
Week 8
Title
Protein Measurement
Description
Measurement of circulating levels of high sensitivity-C-reactive protein.
Time Frame
Week 8
Title
Tumor Necrosis Factor Measurement
Description
Measurement of circulating levels of soluble tumor necrosis factor (TNF) alpha-receptor 1.
Time Frame
Week 8
Title
Tumor Necrosis Factor Measurement #2
Description
Measurement of circulating levels of soluble TNF alpha-receptor 2.
Time Frame
Week 8
Title
Pain Measurement
Description
Pain will be measured with components of the EPHect participant questionnaire using the VAS pain score. Scores range from 0 to 10, higher score is more pain (worse).
Time Frame
Week 12
Title
Pain Measurement
Description
Pain will be measured with components of the EPHect participant questionnaire using the pain catastrophizing scale. Scores range from 0 to 52, higher scores indicate a greater amount of catastrophizing (worse).
Time Frame
Week 12
Title
Pain Measurement
Description
Pain will be measured with components of the EPHect participant questionnaire using the mean number of analgesic and/or opioid pills taken per week.
Time Frame
Week 12
Title
Quality of Life Questionnaire
Description
Physical and mental QOL components will be measured with the Endometriosis Health Profile Questionnaire. Scores range from 0 to 100, higher scores reflect more symptoms and worse health status.
Time Frame
Week 12
Title
Quality of Life Survey
Description
Physical and mental QOL components will be measured with the Short Form-12 survey. There are two components, a physical component summary (PCS) and a mental health component summary (MCS). Both have a range of 0 to 100, higher scores represent better health.
Time Frame
Week 12
Title
inflammatory Markers
Description
Measurement of circulating levels of inflammatory markers (interleukin (IL)-6 and IL-1β.
Time Frame
Week 12
Title
Protein Measurement
Description
Measurement of circulating levels of high sensitivity-C-reactive protein.
Time Frame
Week 12
Title
Tumor Necrosis Factor Measurement
Description
Measurement of circulating levels of soluble tumor necrosis factor (TNF) alpha-receptor 1.
Time Frame
Week 12
Title
Tumor Necrosis Factor Measurement #2
Description
Measurement of circulating levels of soluble TNF alpha-receptor 2.
Time Frame
Week 12

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Female Aged 18-45 Laparoscopically-confirmed endometriosis Premenopausal (at least one period in the past 6 months) VAS pain score of at least 7 out of 10 in the previous 3 months Score below 75 on the AHEI-2010 Exclusion Criteria: Postmenopausal Pregnant Have had a hysterectomy or oophorectomy Have chronic illnesses that are known to affect gastrointestinal absorption of nutrients (celiac disease, Crohn's disease, ulcerative colitis, or cystic fibrosis) A history of kidney stones, cancer (except basal cell carcinoma), or diabetes
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nancy Blythe
Phone
2066676900
Email
nblythe@fredhutch.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Holly Harris
Organizational Affiliation
Fred Hutchinson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fred Hutchinson Cancer Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nancy A Blythe, BA
Phone
206-667-6900
Email
nblythe@fhcrc.org
First Name & Middle Initial & Last Name & Degree
Holly R Harris, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Participant information or blood samples could be used for future research studies or sent to other investigators for future research studies without additional consent from participants. These future research studies will be reviewed by an oversight group known as an institutional review board if required by law. The information that identifies participants will first be removed from the information or blood samples. If participants do not want their information or blood samples to be used for future research studies without their consent, interested persons should not participate in this study.
IPD Sharing Time Frame
Data will be collected and stored indefinitely.
IPD Sharing Access Criteria
Researchers requesting samples in the repository may apply via the completion of a material/data use agreement.

Learn more about this trial

An AHEI Dietary Intervention to Reduce Pain in Women With Endometriosis

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