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

Completed

• Conditions: Gastric Carcinoma; Malignant Peritoneal Neoplasm; Carcinomatosis; Appendix Carcinoma; Colorectal Carcinoma; Malignant Solid Neoplasm
• Interventions: Procedure: Biospecimen Collection; Procedure: Pain Assessment; Other: Questionnaire Administration

• Registration Number: NCT05083338
• Lead Sponsor: M.D. Anderson Cancer Center

Brief 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.

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2021-08-10
• Study First Submitted: 2021-10-07
• Study First Submitted QC: 2021-10-07
• Study First Posted: 2021-10-19
• Status Verified: 2024-02
• Primary Completion: 2024-02-09
• Study Completion: 2024-02-09
• Last Update Submitted: 2024-02-12
• Last Update Posted: 2024-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational (questionnaire, pain assessment, biospecimen)	Pain Assessment	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.
Observational (questionnaire, pain assessment, biospecimen)	Biospecimen Collection	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.
Observational (questionnaire, pain assessment, biospecimen)	Questionnaire Administration	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.

Primary Outcome Measures

Name	Time	Method
Chronic postsurgical pain	through study completion, an average of 1 year	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.

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States