An AHEI Dietary Intervention to Reduce Pain in Women With Endometriosis

Fred Hutchinson Cancer Center109 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

109

Conditions

Endometriosis

Interventions

AHEI dietOTHER

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Locations (1)

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Outcomes

Primary Outcomes

Pain Measurement - Acyclic Pain

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 to 12 weeks

Pain Measurement - Pain Catastrophizing

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

Pain Measurement - Pills

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

Quality of Life EHP-30

QOL 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 to 12 weeks

Quality of Life SF-12 MC

Mental QOL will be measured with the SF-12 Mental Component Summary (MCS). Scores range from 0 to 100, higher scores reflect more symptoms and worse health status.

Time frame: Baseline to 12 weeks

Quality of Life SF-12 PC

Physical QOL will be measured with the SF-12 Physical Component Summary (MCS). Scores range from 0 to 100, higher scores reflect more symptoms and worse health status.

Time frame: Baseline

Inflammatory Markers

Measurement of circulating levels of inflammatory markers (interleukin (IL)-6) with SomaScan

Data from ClinicalTrials.gov

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Time frame: Baseline

Protein Measurement

Measurement of circulating levels of high sensitivity-C-reactive protein with SomaScan

Time frame: Baseline

Tumor Necrosis Factor Measurement

Measurement of circulating levels of soluble tumor necrosis factor (TNF) alpha-receptor 1 with SomaScan

Time frame: Baseline

Tumor Necrosis Factor Measurement #2

Measurement of circulating levels of soluble TNF alpha-receptor 2 with SomaScan

Time frame: Baseline

Pain Measurement - Acyclic Pain

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

Pain Measurement - Pain Catastrophizing

Time frame: Week 4

Pain Measurement - Pills

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

Quality of Life EHP-30

QOL 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

Quality of Life SF-12 PC

Physical QOL will be measured with the SF-12 Physical Component Summary (MCS). Scores range from 0 to 100, higher scores reflect more symptoms and worse health status.

Time frame: Week 4

Quality of Life SF-12 MC

Mental QOL will be measured with the SF-12 Mental Component Summary (MCS). Scores range from 0 to 100, higher scores reflect more symptoms and worse health status.

Time frame: Week 4

Inflammatory Markers

Measurement of circulating levels of inflammatory markers (interleukin (IL)-6 with SomaScan

Time frame: Week 4

Protein Measurement

Measurement of circulating levels of high sensitivity-C-reactive protein with SomaScan

Time frame: Week 4

Tumor Necrosis Factor Measurement

Measurement of circulating levels of soluble tumor necrosis factor (TNF) alpha-receptor 1 from SomaScan

Time frame: Week 4

Tumor Necrosis Factor Measurement #2

Measurement of circulating levels of soluble TNF alpha-receptor 2 from SomaScan

Time frame: Week 4

Pain Measurement - Acyclic Pelvic Pain

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

Pain Measurement - Pain Catastrophizing Score

Time frame: Week 8

Pain Measurement - Pills

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

Quality of Life EHP-30

QOL 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

Quality of Life SF-12 PC

Physical QOL will be measured with the SF-12 Physical Component Summary (MCS). Scores range from 0 to 100, higher scores reflect more symptoms and worse health status.

Time frame: Week 8

Quality of Life SF-12 MC

Mental QOL will be measured with the SF-12 Mental Component Summary (MCS). Scores range from 0 to 100, higher scores reflect more symptoms and worse health status.

Time frame: Week 8

Inflammatory Markers

Measurement of circulating levels of inflammatory markers (interleukin (IL)-6 from SomaScan

Time frame: Week 8

Protein Measurement

Measurement of circulating levels of high sensitivity-C-reactive protein from SomaScan

Time frame: Week 8

Tumor Necrosis Factor Measurement

Measurement of circulating levels of soluble tumor necrosis factor (TNF) alpha-receptor 1 from SomaScan

Time frame: Week 8

Tumor Necrosis Factor Measurement #2

Measurement of circulating levels of soluble TNF alpha-receptor 2 from SomaScan

Time frame: Week 8

Pain Measurement - Acyclic Pelvic Pain

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

Pain Measurement - Pain Catastrophizing Score

Time frame: Week 12

Pain Measurement - Pills

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

Quality of Life EHP-30

QOL 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

Quality of Life SF-12 PC

Physical QOL will be measured with the SF-12 Physical Component Summary (MCS). Scores range from 0 to 100, higher scores reflect more symptoms and worse health status.

Time frame: Week 12

Quality of Life SF-12 MC

Mental QOL will be measured with the SF-12 Mental Component Summary (MCS). Scores range from 0 to 100, higher scores reflect more symptoms and worse health status.

Time frame: Week 12

Inflammatory Markers

Measurement of circulating levels of inflammatory markers (interleukin (IL)-6 from SomaScan

Time frame: Week 12

Protein Measurement

Measurement of circulating levels of high sensitivity-C-reactive protein from SomaScan

Time frame: Week 12

Tumor Necrosis Factor Measurement

Measurement of circulating levels of soluble tumor necrosis factor (TNF) alpha-receptor 1 from SomaScan

Time frame: Week 12

Tumor Necrosis Factor Measurement #2

Measurement of circulating levels of soluble TNF alpha-receptor 2 from SomaScan

Time frame: Week 12

Secondary Outcomes

Pain Measurement - Acyclic Pelvic Pain

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: 6 months

Pain Measurement - Acyclic Pelvic Pain

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: 12 months

Quality of Life EHP-30

QOL 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: 6 months

Quality of Life SF-12 PC

Physical QOL will be measured with the SF-12 Physical Component Summary (MCS). Scores range from 0 to 100, higher scores reflect more symptoms and worse health status.

Time frame: 12 months