The Effect of Soy Protein on Neuropathic Facial Pain

• 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 ]

• 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: Throughout the study ] [ Designated as safety issue: Yes ]

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.

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.

• Dietary Supplement: Isolated soy protein
  30-50 g of protein powder for 3 weeks
  Other Names:

  • PRO-FAM 873
  • Code #066873
• Dietary Supplement: Isolated milk protein
  30-50g of protein powder daily for 3 weeks
  Other Name: PRODIET 85

• Experimental: Soy Protein
  Intervention: Dietary Supplement: Isolated soy protein
• Placebo Comparator: Milk Protein
  Intervention: Dietary Supplement: Isolated milk protein

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

• Louise & Alan Edwards Foundation
• Alan Edwards Centre for Research on Pain