Clinical trial · Interventional
The Effect of Soy Protein on Post- Breast Cancer Surgery Pain
Soy-rich Diet for Preventing Chronic Pain After Breast Cancer Surgery
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Difficulty with recruitment - few eligible for enrolment.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Chronic Disease | — | UNRESOLVED | — |
| Pain | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Isolated milk protein | Dietary Supplement | — | UNRESOLVED |
| Isolated soy protein | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Soy protein
- interventionNames
- Dietary Supplement: Isolated soy protein
- type
- PLACEBO_COMPARATOR
- label
- Milk protein
- interventionNames
- Dietary Supplement: Isolated milk protein
Primary outcomes (1)
- measure
- Number of women in both arms with any pain of any type in operated breast or its vicinity
- timeFrame
- 12 months post-surgery
Secondary outcomes (9)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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. * 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.
References
Publications (0)
Data not yet available