An AHEI Dietary Intervention to Reduce Pain in Women With Endometriosis
Overview
- Phase
- Not Applicable
- Intervention
- AHEI diet
- Conditions
- Endometriosis
- Sponsor
- Fred Hutchinson Cancer Center
- Enrollment
- 109
- Locations
- 1
- Primary Endpoint
- Quality of Life Questionnaire
- Status
- Completed
- Last Updated
- 19 days ago
Overview
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.
Investigators
Holly Harris
Principal Investigator
Fred Hutchinson Cancer Center
Eligibility Criteria
Inclusion Criteria
- •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
- •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
Arms & Interventions
Intervention
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.
Intervention: AHEI diet
Control
Participants in this arm will not receive the dietary intervention.
Outcomes
Primary Outcomes
Quality of Life Questionnaire
Time Frame: Week 12
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.
Pain Measurement
Time Frame: Week 12
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 Survey
Time Frame: Week 12
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.
Tumor Necrosis Factor Measurement
Time Frame: Week 12
Measurement of circulating levels of soluble tumor necrosis factor (TNF) alpha-receptor 1 from SomaScan
inflammatory Markers
Time Frame: Week 12
Measurement of circulating levels of inflammatory markers (interleukin (IL)-6 and IL-1β.
Inflammatory Markers
Time Frame: Week 8
Measurement of circulating levels of inflammatory markers (interleukin (IL)-6 from SomaScan
Protein Measurement
Time Frame: Week 12
Measurement of circulating levels of high sensitivity-C-reactive protein from SomaScan
Tumor Necrosis Factor Measurement #2
Time Frame: Week 12
Measurement of circulating levels of soluble TNF alpha-receptor 2 from SomaScan
Pain Measurement - Acyclic Pain
Time Frame: Baseline to 12 weeks
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 Catastrophizing
Time Frame: Baseline
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 - Pills
Time Frame: Baseline
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 EHP-30
Time Frame: Baseline to 12 weeks
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.
Quality of Life SF-12 MC
Time Frame: Baseline to 12 weeks
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.
Quality of Life SF-12 PC
Time Frame: Baseline
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.
Inflammatory Markers
Time Frame: Baseline
Measurement of circulating levels of inflammatory markers (interleukin (IL)-6) with SomaScan
Protein Measurement
Time Frame: Baseline
Measurement of circulating levels of high sensitivity-C-reactive protein with SomaScan
Tumor Necrosis Factor Measurement
Time Frame: Baseline
Measurement of circulating levels of soluble tumor necrosis factor (TNF) alpha-receptor 1 with SomaScan
Tumor Necrosis Factor Measurement #2
Time Frame: Baseline
Measurement of circulating levels of soluble TNF alpha-receptor 2 with SomaScan
Pain Measurement - Acyclic Pain
Time Frame: Week 4
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 Catastrophizing
Time Frame: Week 4
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 - Pills
Time Frame: Week 4
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 EHP-30
Time Frame: Week 4
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.
Quality of Life SF-12 PC
Time Frame: Week 4
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.
Quality of Life SF-12 MC
Time Frame: Week 4
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.
Inflammatory Markers
Time Frame: Week 4
Measurement of circulating levels of inflammatory markers (interleukin (IL)-6 with SomaScan
Protein Measurement
Time Frame: Week 4
Measurement of circulating levels of high sensitivity-C-reactive protein with SomaScan
Tumor Necrosis Factor Measurement
Time Frame: Week 4
Measurement of circulating levels of soluble tumor necrosis factor (TNF) alpha-receptor 1 from SomaScan
Tumor Necrosis Factor Measurement #2
Time Frame: Week 4
Measurement of circulating levels of soluble TNF alpha-receptor 2 from SomaScan
Pain Measurement - Acyclic Pelvic Pain
Time Frame: Week 8
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).
Protein Measurement
Time Frame: Week 8
Measurement of circulating levels of high sensitivity-C-reactive protein from SomaScan
Pain Measurement - Pain Catastrophizing Score
Time Frame: Week 8
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 - Pills
Time Frame: Week 8
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 EHP-30
Time Frame: Week 8
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.
Quality of Life SF-12 PC
Time Frame: Week 8
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.
Quality of Life SF-12 MC
Time Frame: Week 8
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.
Tumor Necrosis Factor Measurement
Time Frame: Week 8
Measurement of circulating levels of soluble tumor necrosis factor (TNF) alpha-receptor 1 from SomaScan
Tumor Necrosis Factor Measurement #2
Time Frame: Week 8
Measurement of circulating levels of soluble TNF alpha-receptor 2 from SomaScan
Pain Measurement - Acyclic Pelvic Pain
Time Frame: Week 12
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 Catastrophizing Score
Time Frame: Week 12
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 - Pills
Time Frame: Week 12
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 EHP-30
Time Frame: Week 12
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.
Quality of Life SF-12 PC
Time Frame: Week 12
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.
Quality of Life SF-12 MC
Time Frame: Week 12
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.
Inflammatory Markers
Time Frame: Week 12
Measurement of circulating levels of inflammatory markers (interleukin (IL)-6 from SomaScan
Secondary Outcomes
- Pain Measurement(12 months)
- Qualify of Life Questionnaire(6 months)
- Quality of Life Questionnaire(12 months)
- Pain Measurement - Acyclic Pelvic Pain(6 months)
- Pain Measurement - Acyclic Pelvic Pain(12 months)
- Quality of Life EHP-30(6 months)
- Quality of Life SF-12 PC(12 months)