The Effect of Soy Protein on Neuropathic Facial Pain
This study is currently recruiting participants.
Verified January 2012 by McGill University Health Center
Sponsor:
McGill University Health Center
Collaborators:
Louise & Alan Edwards Foundation
Alan Edwards Centre for Research on Pain
Information provided by (Responsible Party):
McGill University Health Center
ClinicalTrials.gov Identifier:
NCT01050244
First received: January 14, 2010
Last updated: January 10, 2012
Last verified: January 2012
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Purpose
Neuropathic facial pain is one form of chronic facial pain lacking effective pharmacotherapy. Interest in the role of complementary and alternative medicine is growing and diet is at the forefront of the search for alternative treatments for pain. Soy protein is one of the most promising dietary ingredients tested for its pain-relieving properties. Results from animal studies show that soy-enriched diets reduce pain due to nerve injury. The purpose of this study is to determine the effects of soy protein supplementation on facial pain.
| Condition | Intervention | Phase |
|---|---|---|
|
Neuralgic Facial Pain |
Dietary Supplement: Isolated soy protein Dietary Supplement: Isolated milk protein |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | The Effect of Soy Protein on Neuropathic Facial Pain: Randomized N-of-1 Trials |
Further study details as provided by McGill University Health Center:
Primary Outcome Measures:
- Pain Intensity [ Time Frame: Baseline and 3 times during the last week of every treatment period ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Pain Quality [ Time Frame: Baseline and 3 times during the last week of every treatment period ] [ Designated as safety issue: No ]
- Quality of life [ Time Frame: Baseline and 3 times during the last week of every treatment period ] [ Designated as safety issue: No ]
- Depression [ Time Frame: Baseline and 3 times during the last week of every treatment period ] [ Designated as safety issue: No ]
- Dietary intake [ Time Frame: Baseline and 3 times during the last week of every treatment period ] [ Designated as safety issue: No ]
- Analgesic medication use [ Time Frame: Baseline and 3 times during the last week of every treatment period ] [ Designated as safety issue: No ]
- Adverse events [ Time Frame: The full 18 weeks until the end of the last treatment period ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 33 |
| Study Start Date: | February 2011 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Soy Protein |
Dietary Supplement: Isolated soy protein
30-50 g of protein powder for 3 weeks
Other Names:
|
| Placebo Comparator: Milk Protein |
Dietary Supplement: Isolated milk protein
30-50g of protein powder daily for 3 weeks
Other Name: PRODIET 85
|
Detailed Description:
Neuropathic facial pain is a complex disorder with mixed results in response to pain medication due to a high degree of variability between patients. To address this issue, we are implementing a unique methodology using a series of N-of-1 or single subject randomized, double blind, controlled studies. With this, we will explore the role of soy protein supplementation in neuropathic facial pain patients. Each patient will be exposed in 3-week intervals to soy protein and a control, milk protein, in three paired treatment periods for a total of 18 weeks. This method allows for the measurement of treatment efficacy in individual distinct patients and has the potential for immediate and continued medical benefit using a simple and readily available dietary ingredient.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male or female, age ≥ 18 years old
- Chronic neuropathic facial pain > 6 months
- Suboptimal pain pharmacotherapy (i.e. additional pain control felt by patient and physician to be necessary)
- Pain intensity score ≥ 4 on a 10 cm visual analogue scale (VAS)
- Stable medication use (if any) over 4 weeks before starting the trial. Current medication use will be maintained and no additional pharmacotherapy may be introduced during the trial.
- Up to date mammogram and gynecological evaluations.
Exclusion Criteria:
- History of significant heart, gastro-intestinal, liver or kidney disease
- History of alcohol/narcotic abuse or current excessive alcohol consumption
- History or diagnosis of cancer
- History of breast tumors, predisposition to breast cancer or a family member with breast cancer
- History of hormonal or gynaecological disease
- Current use of hormonal replacement therapy (HRT), except thyroid HRT
- Pregnant or breastfeeding women
- Use of any anticoagulant or blood thinner except acetylsalicyclic acid
- Malabsorption of any kind
- Diagnosed lactase deficiency;
- Known allergy to any of the dietary products
- Daily consumption of soy protein in quantities exceeding 10 g/day
- Strict vegetarians (i.e. no animal derived dietary sources)
- Recent antibiotic use
- Any previous psychiatric diagnosis before pain onset
- Body mass index > 35
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01050244
Contacts
| Contact: Yoram Shir, MD | 514-934-8558 | yoram.shir@muhc.mcgill.ca |
| Contact: Sylvie Toupin | 514-934-1934 ext 44348 | sylvie.toupin@mail.mcgill.ca |
Locations
| Canada, Quebec | |
| McGill University Health Centre | Recruiting |
| Montreal, Quebec, Canada, H3G 1A4 | |
| Contact: Sylvie Toupin 514-934-1934 ext 44348 sylvie.toupin@mail.mcgill.ca | |
| Principal Investigator: Yoram Shir, MD | |
| Sub-Investigator: Alexis Codrington, PhD | |
| Sub-Investigator: Stephanie Chevalier, PhD | |
| Sub-Investigator: Mark A Ware, MD | |
Sponsors and Collaborators
McGill University Health Center
Louise & Alan Edwards Foundation
Alan Edwards Centre for Research on Pain
Investigators
| Principal Investigator: | Yoram Shir, MD | McGill University Health Center |
More Information
No publications provided
| Responsible Party: | McGill University Health Center |
| ClinicalTrials.gov Identifier: | NCT01050244 History of Changes |
| Other Study ID Numbers: | GEN 09-117 |
| Study First Received: | January 14, 2010 |
| Last Updated: | January 10, 2012 |
| Health Authority: | Canada: Health Canada |
Keywords provided by McGill University Health Center:
|
Soy protein Milk protein Neuropathic |
Additional relevant MeSH terms:
|
Facies Facial Pain Disease Attributes Pathologic Processes |
Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on June 18, 2013