Oral Prednisolone Effect on Cancer WHO Stepladder Analgesia Protocol

NCT04162379 | Completed Phase 2

• 1 other identifier: R.19.10.656.R1
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction; World Health Organization (WHO) analgesic ladder; Step I recommends non-opioid analgesics for mild pain. Step II specifies the use of weak opioids for moderate pain. Step III comprises the use of strong opioids for severe pain. Cancer pain management using opioids administered alone or in combination with adjuvant analgesics. Corticosteroids adjuvant use for neuropathic and bone pain treatment. However, despite widespread use of corticosteroids, scientific evidence about its efficacy in cancer pain management is limited. This protocol aims to clarify pors and cons of interrupted steroid dosing in chronic cancer pain WHO stepladder analgesia protocol. Methods; Prospective quizi-pre-post experimental study will be conducted after IRB approval in the Mansoura oncology canter pain clinic-Faculty of medicine Mansoura University Egypt. Verbal informed consent will be obtained from the respondents (patients) for the interview. Furthermore, the data collected from each patient will be kept confidential and used strictly only for the purpose of the study. Patients will be allocated as single group and will take oral prednisolone (sulopride10 mg) single dose every two days for 4 successive weeks then the next two weeks as washout period (stop dosing gradually by taking 5 mgs for 3 successive dosing every 2nd day over a week, then stop the oral steroid drug totally over the 2nd week of the washout period. The second period of the study will start by taking the oral prednisolone (sulopride10 mg) every fourth day for the next 4 weeks after which the patient will get another washout two weeks period (stop dosing gradually 5 mgs for 3 successive dosing every 4th day then stop the drug totally).A questionnaire-based interview using Brief Pain Inventory-Short Form (BPI-sf) (16) based on VAS pain score as a rough tool for pain intensity Data collection: Primary Outcome: global Pain intensity, assessed by a visual analogue scale (VAS) 0-10. Secondary outcomes based on the Brief Pain Inventory short form (BPI-sf).

Conditions

Steroid Anlgesia in Cancer Pain

Keywords

Steroid, analgesia, Prednisolone, Cancer, cancer Pain, pain WHO stepladder.

Outcome Measures

Primary Outcomes (1)

• Pain intensity: visual analogue scale

  global Pain intensity, assessed by a visual analogue scale (VAS) 0-10.

  from day one to day 28

Study Arms (1)

Prospective quizi-pre-post oral predensolone

OTHER

single group and will take oral prednisolone (sulopride10 mg) single dose every two days for 4 successive weeks then the next two weeks as washout period (stop dosing gradually by taking 5 mgs for 3 successive dosing every 2nd day over a week, then stop the oral steroid drug totally over the 2nd week of the washout period. The second period of the study will start by taking the oral prednisolone (sulopride10 mg) every fourth day for the next 4 weeks after which the patient will get another washout two weeks period (stop dosing gradually 5 mgs for 3 successive dosing every 4th day then stop the drug totally).

Drug: Oral tablet

Interventions

Oral tablet DRUG

Patients will be allocated as single group and will take oral prednisolone (sulopride10 mg) single dose every two days for 4 successive weeks then the next two weeks as washout period (stop dosing gradually by taking 5 mgs for 3 successive dosing every 2nd day over a week, then stop the oral steroid drug totally over the 2nd week of the washout period. The second period of the study will start by taking the oral prednisolone (sulopride10 mg) every fourth day for the next 4 weeks after which the patient will get another washout two weeks period (stop dosing gradually 5 mg for 3 successive dosing every 4th day then stop the drug totally).

Also known as: oral adjuvant analgesia

Prospective quizi-pre-post oral predensolone

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• patients with severe other medical disease (organ failure-uncontrolled DM-uncontrolled Hypertension) or psychiatric problems and unable or unwilling to provide the required information will be excluded from the study, patients on chemotherapy or radiotherapy during the study period.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Oncolgy Center, Mansoura University,

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Location

MeSH Terms

Conditions

Agnosia; Neoplasms; Cancer Pain

Interventions

Tablets

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Officials

• mohamed Ghanem, A professor

  Mansoura Univeristy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor os anesthesia ICU & Pain medicine.

Study Record Dates

• First Submitted: November 11, 2019
• First Posted: November 14, 2019
• Study Start: November 15, 2019
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: March 10, 2020

Record last verified: 2020-03

Locations

EG (1)