Endometriosis Clinical Trial
Official title:
An AHEI Dietary Intervention to Reduce Pain in Women With Endometriosis
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Fred Hutchinson Cancer Research Center | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
Fred Hutchinson Cancer Center | National Institute of Nursing Research (NINR) |
United States,
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 |
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