An AHEI Dietary Intervention to Reduce Pain in Women With Endometriosis

Endometriosis Clinical Trial

Official title:

An AHEI Dietary Intervention to Reduce Pain in Women With Endometriosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04259788
• Other study ID #: RG1004314
• Secondary ID: 8772R01NR017951
• Status: Recruiting
• Phase: N/A
• Start date: May 24, 2021
• Est. completion date: January 31, 2025

Study information

• Verified date: March 2024
• Source: Fred Hutchinson Cancer Center
• Contact: Nancy Blythe
• Phone: 2066676900
• Email: nblythe[@]fredhutch.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 31, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Endometriosis

Intervention

Other:
• AHEI diet
Main intervention is the consumption of an AHEI diet for 12 weeks.

Locations

Country	Name	City	State
United States	Fred Hutchinson Cancer Research Center	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Center	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Baseline
Primary	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).	Baseline
Primary	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.	Baseline
Primary	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.	Baseline
Primary	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.	Baseline
Primary	Inflammatory Markers	Measurement of circulating levels of inflammatory markers (interleukin (IL)-6 and IL-1ß.	Baseline
Primary	Protein Measurement	Measurement of circulating levels of high sensitivity-C-reactive protein.	Baseline
Primary	Tumor Necrosis Factor Measurement	Measurement of circulating levels of soluble tumor necrosis factor (TNF) alpha-receptor 1.	Baseline
Primary	Tumor Necrosis Factor Measurement #2	Measurement of circulating levels of soluble TNF alpha-receptor 2.	Baseline
Primary	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).	Week 4
Primary	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).	Week 4
Primary	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.	Week 4
Primary	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.	Week 4
Primary	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.	Week 4
Primary	Inflammatory Markers	Measurement of circulating levels of inflammatory markers (interleukin (IL)-6 and IL-1ß.	Week 4
Primary	Protein Measurement	Measurement of circulating levels of high sensitivity-C-reactive protein.	Week 4
Primary	Tumor Necrosis Factor Measurement	Measurement of circulating levels of soluble tumor necrosis factor (TNF) alpha-receptor 1.	Week 4
Primary	Tumor Necrosis Factor Measurement #2	Measurement of circulating levels of soluble TNF alpha-receptor 2.	Week 4
Primary	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).	Week 8
Primary	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).	Week 8
Primary	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.	Week 8
Primary	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.	Week 8
Primary	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.	Week 8
Primary	Inflammatory Markers	Measurement of circulating levels of inflammatory markers (interleukin (IL)-6 and IL-1ß.	Week 8
Primary	Protein Measurement	Measurement of circulating levels of high sensitivity-C-reactive protein.	Week 8
Primary	Tumor Necrosis Factor Measurement	Measurement of circulating levels of soluble tumor necrosis factor (TNF) alpha-receptor 1.	Week 8
Primary	Tumor Necrosis Factor Measurement #2	Measurement of circulating levels of soluble TNF alpha-receptor 2.	Week 8
Primary	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).	Week 12
Primary	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).	Week 12
Primary	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.	Week 12
Primary	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.	Week 12
Primary	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.	Week 12
Primary	inflammatory Markers	Measurement of circulating levels of inflammatory markers (interleukin (IL)-6 and IL-1ß.	Week 12
Primary	Protein Measurement	Measurement of circulating levels of high sensitivity-C-reactive protein.	Week 12
Primary	Tumor Necrosis Factor Measurement	Measurement of circulating levels of soluble tumor necrosis factor (TNF) alpha-receptor 1.	Week 12
Primary	Tumor Necrosis Factor Measurement #2	Measurement of circulating levels of soluble TNF alpha-receptor 2.	Week 12