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Oral Prednisolone Effect on Cancer WHO Stepladder Analgesia Protocol

NCT04162379 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2020-03-10

No results posted yet for this study

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

Interventions

DRUG

Oral tablet

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).

Sponsors & Collaborators

  • Mansoura University

    lead OTHER

Principal Investigators

  • mohamed Ghanem, A professor · Mansoura Univeristy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-15
Primary Completion
2020-03-01
Completion
2020-03-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04162379 on ClinicalTrials.gov