PainPhase 2NCT01047774
The Effect of Soy Protein on Post- Breast Cancer Surgery Pain
A Phase 2 study testing Isolated soy protein and Isolated milk protein in people with Pain and Chronic Disease, run by Dr. Yoram Shir at 4 sites in Canada.
Trial summary
The incidence of chronic pain after breast cancer surgery (CPBCS) is high in women diagnosed with breast cancer. Similar to other chronic postoperative pain conditions, existing treatments for CPBCS do not always work. Read more about this study
- Who is it for?
- Ages 21 to 99 years, women only
- Conditions the study is for
- Pain, Chronic Disease, Breast Cancer
- What is being tested?
- Isolated soy protein and Isolated milk protein
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 4 sitesCanada
- Study dates
- Mar 2010to May 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women diagnosed with breast cancer and scheduled for elective breast cancer surgery (excluding breast biopsy) with axillary lymph node dissection (total and/or sentinel node excision).
- Women who are 21 years or older.
Who cannot join
- History of significant heart, gastro-intestinal, liver or kidney disease.
- Use of the anticoagulant, warfarin or Coumadin.
- Malabsorption of any kind.
- Diagnosed lactase deficiency.
- Known allergy to any of the tested dietary products.
- Basic daily consumption of soy protein in quantities exceeding 10 g/day.
Show all 19Show fewer
- Women who are strict vegetarians (i.e. no animal derived dietary sources).
- The use of the following narcotics or adjuvant pharmacotherapy: opioids, anticonvulsants, antidepressants and steroids (except antidepressant use specifically for depression).
- Tumour size (if known) > 3cm(i.e. size before pre-operative chemotherapy, if administered).
- Locally advanced breast cancer.
- Inflammatory breast cancer.
- Paget's disease of the breast with palpable mass.
- Suspected metastasis.
- Suspected micrometastasis.
- Previous breast surgery of any kind (except needle biopsy).
- The need for bilateral breast surgery.
- The existence of other known cancer, including metastasis, either in the other breast or elsewhere.
- Previous or current endocrine cancer therapy (e.g. selective estrogen receptor modulators, aromatase inhibitor).
- Body mass index (BMI) > 35.
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
Royal Victoria Hospital
Montreal, Quebec, H3A 1A1
McGill University Health Centre
Montreal, Quebec, H3G 1A4
Jewish General Hospital
Montreal, Quebec, H3T 1E2
St. Mary's Hospital Center
Montreal, Quebec, H3T 1M5
About this study
Official title: Soy-rich Diet for Preventing Chronic Pain After Breast Cancer Surgery
The incidence of chronic pain after breast cancer surgery (CPBCS) is high in women diagnosed with breast cancer. Similar to other chronic postoperative pain conditions, existing treatments for CPBCS do not always work. Adopting the concept of using pain relieving measures prior to surgery rather than after it, may lead to decreased postoperative pain levels. Soy has been shown to have pain-relieving properties and may reduce the risk for developing chronic post-surgical pain. The purpose of this study is to determine the effects of adding soy protein to the diet before surgery on the development of chronic pain.
Read the detailed description
Preclinical studies indicate that soy consumption suppresses the development of pain behavior and hyperalgesia following nerve injury. The pain-suppressing properties of soy protein have been shown to be predominately the result of soy pre-operative consumption.
This is a randomized, double blind, placebo-controlled clinical trial for women diagnosed with breast cancer and scheduled to undergo breast cancer surgery. The trial will comprise two phases: 1. A 2-week preoperative dietary manipulation phase, and 2. A one-year postoperative follow up period. In the first phase eligible candidates will undergo a basic dietary evaluation followed by stratification into 4 study groups, based on their pre-vs. postmenopausal status and the planned type of surgery, i.e., formal mastectomy vs. breast-conserving surgery. Women in each group will be randomized to receive either powdered soy protein in the experimental group or milk protein in the control group. During the second, post-surgical phase women will resume their normal diet. If shown to be beneficial, this simple dietary manipulation may prevent one of the most severe sequelae of breast cancer.
- Conditions
- Pain, Chronic Disease, Breast Cancer
- Being tested
- Isolated soy protein, Isolated milk protein
- Keywords
- soy protein, diet
- Medical subject headings
- Pain, Chronic Disease, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isolated soy proteinDietary supplement
Also called PRO-FAM 873, Code #066873
30-50g of protein powder daily for 2 weeks.
Isolated milk proteinDietary supplement
Also called PRODIET 85
30-50g of protein powder daily for 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Soy protein | Experimental | Not described Receives: Dietary Supplement: Isolated soy protein |
| Milk protein | Placebo comparator | Not described Receives: Dietary Supplement: Isolated milk protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of women in both arms with any pain of any type in operated breast or its vicinity
Measured: 12 months post-surgery
Secondary outcomes (9)
Pain intensity (acute)
Measured: Up to 7 days post-surgery
Pain intensity (chronic)
Measured: Up to 12 months post-surgery
Analgesic medication use
Measured: Up to 12 months post-surgery
Pain quality
Measured: Up to 12 months post-surgery
Anxiety and Depression
Measured: Up to 12 months post-surgery
Disability
Measured: Up to 12 months post-surgery
Adverse events
Measured: 2 weeks during dietary supplementation
Childhood and adolescence consumption of soy
Measured: Baseline
Adverse events
Measured: Up to 12 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2010 (estimated)
- Study startMar 2010
- Primary completionMay 2013
- Study completionMay 2013
Why it stopped: Difficulty with recruitment - few eligible for enrolment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Yoram Shir
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Louise & Alan Edwards Foundation, McGill University
- Responsible party
- Sponsor-investigator, Dr. Yoram Shir, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Yoram Shir, MD, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01047774
- Sponsor's protocol ID
- A02-M102-07A
- Other IDs
- 5R21CA125873-02
- Status last verified
- Oct 2015
- First submitted
- 12 Jan 2010
- Last updated
- 7 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Soy-rich Diet for Preventing Chronic Pain After Breast Cancer Surgery
- ClinicalTrials.gov ID
- NCT01047774
- Acronym / sponsor ID
- A02-M102-07A
- Conditions
- Pain, Chronic Disease, Breast Cancer
- Keywords
- soy protein, diet
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty with recruitment - few eligible for enrolment.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Dr. Yoram ShirUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Louise & Alan Edwards Foundation, McGill University
- Study start
- Mar 2010
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 13 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The incidence of chronic pain after breast cancer surgery (CPBCS) is high in women diagnosed with breast cancer. Similar to other chronic postoperative pain conditions, existing treatments for CPBCS do not always work. Adopting the concept of using pain relieving measures prior to surgery rather than after it, may lead to decreased postoperative pain levels. Soy has been shown to have pain-relieving properties and may reduce the risk for developing chronic post-surgical pain. The purpose of this study is to determine the effects of adding soy protein to the diet before surgery on the development of chronic pain.
Detailed description
Preclinical studies indicate that soy consumption suppresses the development of pain behavior and hyperalgesia following nerve injury. The pain-suppressing properties of soy protein have been shown to be predominately the result of soy pre-operative consumption.
This is a randomized, double blind, placebo-controlled clinical trial for women diagnosed with breast cancer and scheduled to undergo breast cancer surgery. The trial will comprise two phases: 1. A 2-week preoperative dietary manipulation phase, and 2. A one-year postoperative follow up period. In the first phase eligible candidates will undergo a basic dietary evaluation followed by stratification into 4 study groups, based on their pre-vs. postmenopausal status and the planned type of surgery, i.e., formal mastectomy vs. breast-conserving surgery. Women in each group will be randomized to receive either powdered soy protein in the experimental group or milk protein in the control group. During the second, post-surgical phase women will resume their normal diet. If shown to be beneficial, this simple dietary manipulation may prevent one of the most severe sequelae of breast cancer.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Soy protein | Experimental | Dietary Supplement: Isolated soy protein |
| Milk protein | Placebo comparator | Dietary Supplement: Isolated milk protein |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women diagnosed with breast cancer and scheduled for elective breast cancer surgery (excluding breast biopsy) with axillary lymph node dissection (total and/or sentinel node excision).
- Women who are 21 years or older.
Key exclusion criteria (19 listed)
- History of significant heart, gastro-intestinal, liver or kidney disease.
- Use of the anticoagulant, warfarin or Coumadin.
- Malabsorption of any kind.
- Diagnosed lactase deficiency.
- Known allergy to any of the tested dietary products.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Isolated soy proteinAlso: PRO-FAM 873, Code #06687330-50g of protein powder daily for 2 weeks. | Dietary supplement | Soy protein |
| Isolated milk proteinAlso: PRODIET 8530-50g of protein powder daily for 2 weeks. | Dietary supplement | Milk protein |
Primary outcome
Number of women in both arms with any pain of any type in operated breast or its vicinity
Time frame: 12 months post-surgery
9 secondary outcomes
Pain intensity (acute)
Time frame: Up to 7 days post-surgery
Pain intensity (chronic)
Time frame: Up to 12 months post-surgery
Analgesic medication use
Time frame: Up to 12 months post-surgery
Pain quality
Time frame: Up to 12 months post-surgery
Anxiety and Depression
Time frame: Up to 12 months post-surgery
Disability
Time frame: Up to 12 months post-surgery
Adverse events
Time frame: 2 weeks during dietary supplementation
Childhood and adolescence consumption of soy
Time frame: Baseline
Adverse events
Time frame: Up to 12 months post-surgery
Results and safety
The study was stopped early (reason given: Difficulty with recruitment - few eligible for enrolment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2015.
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yoram Shir, MD principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Isolated soy protein and Isolated milk protein in people with Pain and Chronic Disease, run by Dr. Yoram Shir at 4 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Difficulty with recruitment - few eligible for enrolment.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of women in both arms with any pain of any type in operated breast or its vicinity (time frame: 12 months post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2015.