Clinical trial · Observational
Effect of Chemotherapy on Pain Sensitivity and Patient-reported Symptoms
Effect of Chemotherapy on Pain Sensitivity and Patient-reported Symptoms in Early Stage Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Many breast cancer survivors report chronic pain that develops or worsens following chemotherapy. The impact of chemotherapy on the development of chronic pain is uncertain. In this proposal, we are studying the impact of chemotherapy on a patient's sensitivity to pain. We are also investigating whether a patient's sensitivity to pain is related to how many symptoms she experiences during treatment.
Conditions
Conditions (2)
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 Pain | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Adjuvant chemotherapy
- description
- Subjects will undergo pain testing, then receive standard of care chemotherapy, and then undergo pain testing.
Primary outcomes (1)
- measure
- Feasibility of recruiting patients at chemotherapy initiation
- timeFrame
- 15 weeks
- description
- Feasibility will be measured by the proportion of women who complete the post-chemotherapy assessment among those consenting to participate in the trial.
Secondary outcomes (2)
- measure
- Change in Pain Sensitivity in Breast Cancer Patients Associated with Chemotherapy
- timeFrame
- 15 weeks
- description
- Patients will undergo quantitative sensory testing to identify change in pain threshold and in the magnitude of conditioned pain modulation before chemotherapy and shortly after the final dose of chemotherapy.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Female gender * Histologically proven stage I-III invasive carcinoma of the breast who is planning to receive a standard dose of adjuvant chemotherapy. * Surgical resection should be complete at the time of study enrollment. * Eastern Cooperative Oncology Group performance status 0-2. Exclusion Criteria: * Average pain over the past 24 hours of 4 or greater on a 0-10 scale. * Peripheral sensory neuropathy grade 2 or higher. * Personal history of schizophrenia or major depressive disorder, or history of suicidal ideation or attempt within the past 2 years. * Thumbnail abnormalities on either hand (such as artificial nails) that are likely to alter pain perception during testing. * Pregnant or nursing. * No prior chemotherapy for any reason
References
Publications (0)
Data not yet available