Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04162379 |
| Other study ID # |
R.19.10.656.R1 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 2
|
| First received |
|
| Last updated |
|
| Start date |
November 15, 2019 |
| Est. completion date |
March 1, 2020 |
Study information
| Verified date |
March 2020 |
| Source |
Mansoura University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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).
Description:
Introduction: pain in cancer patients is based on the concept of the World Health
Organization (WHO) analgesic ladder and was recently updated with the EAPC (European
Association for Palliative Care) recommendations. (1) Cancer pain management using opioids
administered alone or in combination with adjuvant analgesics. Spinal cord compression,
superior vena cava obstruction, raised intracranial pressure, and bowel obstruction is better
established than in other nonspecific indications 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. According to the
cancer Pain Management Index (PMI) (2), approximately one-third of patients do not receive
appropriate analgesia proportional to their pain intensity (PI). This protocol aims to
clarify pors and cons of interrupted steroid dosing in chronic cancer pain WHO stepladder
analgesia protocol.
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 (4). Recently the European Association for
Palliative Care (EAPC) recommendations (5, 6). Nociceptive and neuropathic components of
cancer pain responsiveness to opioids is necessary to achieve good pain alleviation. Medical
data demonstrate that complete pain relief is rarely achieved in cancer patients;
nonetheless, it can be significantly reduced (7). However, some authors have suggested
eliminating the second step of the analgesic ladder, with weak opioids being replaced with
low doses of oral morphine (8, 9).
Inadequate assessment leads to inadequate management of cancer pain. Brief Pain Inventory
(PI), a pain assessment tool that measures both the intensity of the pain (sensory dimension)
and the interference of cancer pain in the patient's life (reactive dimension). It also
queries the patient about pain relief, pain quality, and patient perception of the cause of
pain. (10) The Pain Management Index (PMI) is widely used in the assessment of pain
management, and negative scores are traditionally considered to indicate inadequate pain
management. PMI scores are inversely associated with the proportion of patients with pain
interference (PI). However, PMI scores of − 1 do not always indicate inadequate pain
management; pain management should, therefore, be evaluated from multiple perspectives.
Hypothalamic-pituitary-Adrenal Axis (HPA) axis, sudden cessation of corticosteroid therapy
may result in adrenal failure. Clinically significant HPA axis suppression is rare if a
steroid is administered for less than 3 weeks (11). Steroid withdrawal syndromes: Relapse of
the disease, symptoms of steroid withdrawal syndrome such as lethargy, depression, anorexia,
nausea, myalgia, or arthralgia (12). Steroid Tapering: The most suitable method of tapering
has not been established as yet. After the glucocorticoid withdrawal, the hypothalamic and
pituitary functions recover first, followed by the adrenocortical function. Full recovery of
adrenal function can take months, or even up to a year (13), especially after prolonged
steroid treatment with high doses. A possible scheme of steroid discontinuation is
Prednisolone or equivalent daily dose≥ 7.5 mg reduce rapidly 2.5 mg every 3-4 days, then
5-7.5 mg reduce by 1 mg every 2-4 weeks, then < 5 mg Reduce by 1 mg every 2-4 weeks (13).
Prednisolone relative biologic potencies are; Salt retention 0.75, Anti-inflammatory effect
3, and HPA axis suppression 4. Nociception consists of four stages: Transduction (in
peripheral nociceptors), transmission (via neurons), modulation, and pain perception. The
possible role of steroids on every step of remain unclear; Reduction in inflammation
decreases nociceptors activation (14) , inhibit the expression of collagenase, reduce
pro-inflammatory cytokines, stimulate the synthesis of lipocortin (15), reduction of
peritumoral edema leads to the improvement in analgesia in brain metastases (16) and spinal
cord compression (17) , Decrease of spontaneous discharge & reduce neuropathic pain, Modulate
neural activity and plasticity. There has been little evidence for this in the literature
with cancer-induced pain, nausea, and vomiting, fatigue, cancer-induced anorexia-cachexia,
depressed mood, or poor general well-being and dyspnea. (18)
