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NCT05083338 Clinical Trial

Psychological, Psychophysical and Epigenetic Determinants of Chronic Pain After Cytoreductive - Hyperthermic Intraoperative Chemotherapy

Malignant Solid Neoplasm Clinical Trial

Official title:
Prospective Evaluation of Psychological, Psychophysical and Epigenetic Determinants of Chronic Pain After Cytoreductive - Hyperthermic Intraoperative Chemotherapy in Adult Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05083338
Other study ID # 2021-0027
Secondary ID NCI-2021-0968420
Status Completed
Phase
First received
Last updated
Start date August 10, 2021
Est. completion date February 9, 2024

Study information
Verified date February 2024
Source M.D. Anderson Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study learns if depression, anxiety, and catastrophizing (thought patterns that prompt people to expect the worst) are associated with chronic pain after surgery among patients who are scheduled to have cytoreductive surgery with intraoperative hyperthermic chemotherapy. Information from this study may improve the understanding of persistent and chronic postsurgical pain integrating multiple layers of biological and behavioral sciences.

Description:

PRIMARY OBJECTIVE: I. To evaluate the association of preoperative psychological risk factors (depression, anxiety or catastrophizing) with the development of chronic postsurgical pain after cytoreductive surgery with intraoperative hyperthermic chemotherapy (CRS-HIPEC). SECONDARY OBJECTIVES: I. To evaluate the association of preoperative psychological risk factors (depression, anxiety or catastrophizing) with the development of persistent postsurgical pain after CRS-HIPEC. II. To evaluate the association between preoperative abnormal sensory disturbances and chronic postsurgical pain after CRS-HIPEC. III. To assess the association of blood micro ribonucleic acids (RNAs) signatures with the development of chronic postsurgical pain after CRS-HIPEC. IV. To determine the rate of and factors associated with persistent and chronic opioid use after CRS-HIPEC. V. To determine the rate of persistent and chronic postsurgical anxiety and depression. VI. To investigate changes in psychological risk factors (depression, anxiety or catastrophizing) and sensory disturbances after CRS-HIPEC overtime. EXPLORATORY OBJECTIVE: I. To explore the impact of perioperative (in-patient) opioid use, non-opioid analgesic use and anesthetics on the development of persistent and chronic opioid use after CRS-HIPEC. OUTLINE: Patients complete questionnaires over 15 minutes and undergo pain assessments prior to surgery and at 3, 6 and 12 months after surgery. Patients also undergo blood sample collection before surgery and optionally at 3, 6 and 12 months after surgery.

Recruitment information / eligibility
Status Completed
Enrollment 24
Est. completion date February 9, 2024
Est. primary completion date February 9, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 18 years of age or older; with or without history of preoperative abdominal pain - American Society of Anesthesiologists physical status (ASA) 1-4 - Scheduled surgery: open CRS-HIPEC surgery for primary peritoneal malignancy or secondary carcinomatosis (i.e., appendiceal, colorectal and gastric cancers) - Written informed consent Exclusion Criteria: - ASA >= 4 or emergency surgeries - Patients with extra-abdominal metastatic disease - Patients cognitive or neurologically unable to complete questionnaires preoperatively - Non-English-speaking patients - Pregnant women

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Biospecimen Collection
Undergo blood sample collection
• Pain Assessment
Undergo pain assessment
Other:
• Questionnaire Administration
Complete questionnaires

Locations
Country Name City State
United States M D Anderson Cancer Center Houston Texas

Sponsors (1)
Lead Sponsor Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Chronic postsurgical pain Defined as pain that develops or increases in intensity compared to preoperative after cyotreductive surgery with intraoperative hyperthermic chemotherapy (CRS-HIPEC), lasts for more than 6 months. through study completion, an average of 1 year
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