UMIN-CTR Clinical Trial

Public title

A Clinical Study of the Efficacy and Safety of Corticosteroids for Cancer-induced Neuropathic Pain.

Acronym

A Clinical Study of the Efficacy and Safety of Corticosteroids for Cancer-induced Neuropathic Pain.

Scientific Title

A Prospective, Multicenter, Observational Study of the Efficacy and Safety of Corticosteroids for Tumor-Induced Central and Peripheral Neuropathic Pain in Cancer Patients.

Scientific Title:Acronym

A Prospective Observational Study of the Efficacy and Safety of Corticosteroids for Tumor-Induced Neuropathic Pain.

Region

Japan

Condition

Cancer pain

Classification by specialty

Medicine in general	Anesthesiology	Adult

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate the effectiveness and safety of systemic administration of corticosteroids for the treatment of cancer induced central and peripheral neuropathic pain.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

To compare the difference of pain intensity (worst pain in 24 hours) between baseline, 72 hours later and 168 hours later.

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

999

years-old

>

Gender

Male and Female

Key inclusion criteria

Patients over 20 years old
Patients who have been diagnosed with cancer.
Patients in the hospital
Patients with cancer pain (Brief Pain Inventory short form; worst pain intensity score of 4 or higher in the past 24 hours)
Patients will be scheduled to receive regular corticosteroids for the treatment of cancer-induced neuropathic pain

Key exclusion criteria

Patients whose physicians consider it inappropriate to participate in the research.
Patients who are pregnant, lactating, or may be pregnant.
Patients with diabetes who have poor glycemic control who need additional insulin injections
Patients with an infection-caused fever of 38 degrees or higher
Patients undergoing treatment for an active gastrointestinal ulcer
Patients with diagnoses of hematological malignancy
Serious adverse events due to corticosteroid in the past
Patients who started a new anticancer treatment with a molecularly targeted agency or immune checkpoint inhibitor within 2 weeks, or are scheduled to start the treatment within 1 week
Patients were administrated corticosteroids more than the scheduled dose on the day before the start of treatment
Patients scheduled to administrate corticosteroids more than its regular doses in one week for the treatment of adverse effects by anticancer therapy
Patients who are scheduled to receive surgery for the pain control in a week

Target sample size

200

Name of lead principal investigator

1st name	Keita
Middle name
Last name	Tagami

Organization

Tohoku University Graduate School of Medicine

Division name

Palliative Medicine

Zip code

9808575

Address

2-1, Seiryo-machi, Aobaku, Sendai, Miyagi, 9808575, Japan

TEL

0227177366

Email

keita.tagami.d7@tohoku.ac.jp

Name of contact person

1st name	Keita
Middle name
Last name	Tagami

Organization

Tohoku University Graduate School of Medicine

Division name

Palliative Medicine

Zip code

9808575

Address

2-1, Seiryo-machi, Aobaku, Sendai, Miyagi, 9808575, Japan

TEL

0227177366

Homepage URL

Email

keita.tagami.d7@tohoku.ac.jp

Institute

Tohoku University Graduate School of Medicine

Institute

Department

Personal name

Organization

Japan Science and Technology Agency

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Ethics Committee of the Graduate School of Medicine

Address

2-1, Seiryo-machi, Aoba-ku, Sendai, Japan

Tel

0227178007

Email

med-kenkyo@grp.tohoku.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2020

Year

06

Month

01

Day

URL releasing protocol

https://www.mdpi.com/2072-6694/17/10/1630

Publication of results

Published

URL related to results and publications

https://pubmed.ncbi.nlm.nih.gov/40427128/

Number of participants that the trial has enrolled

107

Results

Pain Relief: The mean worst pain intensity score significantly decreased from 8.2 plus or minus 1.9 at baseline to 5.2 plus or minus 2.9 at 72 hours, and further to 4.4 plus or minus 3.0 at 168 hours (p less than 0.01 for both). Similarly, the mean average pain intensity score decreased from 5.8 plus or minus 2.2 at baseline to 3.0 plus or minus 2.5 at 168 hours (p less than 0.01).

Results date posted

2026

Year

06

Month

03

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

The baseline characteristics of the 107 enrolled patients with cancer-related neuropathic pain are as follows:
Age: Mean 62.6 plus or minus 13.2 years
Sex: Female 57 (53.3 percent), Male 50 (46.7 percent)
Primary Cancer Sites: Lung 27 (25.2 percent), Gastrointestinal 18 (16.8 percent), Breast 13 (12.1 percent), Gynecological 13 (12.1 percent), Head and neck 10 (9.3 percent), Urinary 7 (6.5 percent), and others 19 (17.7 percent)
Pathophysiological Mechanism of Pain: Malignant brain tumors 27 (25.2 percent), Leptomeningeal carcinomatosis 7 (6.5 percent), Spinal cord involvement 22 (20.6 percent), Radiculopathy 30 (28.0 percent), and Peripheral nerve involvement 21 (19.6 percent)
Performance Status: AKPS mean score of 47.3 plus or minus 18.4
Regular Opioids: 72 patients (67.3 percent) with a median Morphine Equivalent Daily Dose of 47.5 mg (Interquartile Range 30 to 120 mg)
Other Analgesics: NSAIDs 47 (43.9 percent), Acetaminophen 46 (43.0 percent), Gabapentinoids 28 (26.2 percent)
Baseline Corticosteroid Use: Median Dexamethasone-Equivalent Daily Dose of 6.6 mg per day (Interquartile Range 4.0 to 8.0 mg per day). Dexamethasone was used in 78 (72.9 percent), Betamethasone in 21 (19.6 percent), and Prednisolone in 8 (7.5 percent)

Participant flow

Screened: 108 cancer patients with neuropathic pain who initiated or escalated corticosteroid therapy
Not Enrolled: 1 patient excluded due to missing data
Enrolled and Baseline Assessment (T0): 107 patients consecutively analyzed
T1 Assessment (72 hours): 102 patients analyzed (5 patients had missing data or discontinued treatment)
T2 Assessment (168 hours): 97 patients analyzed (10 patients in total had missing data or discontinued treatment)
Reasons for Discontinuation (16 cases total): 5 cases due to completion of follow-up, 4 cases due to lack of effectiveness, 3 cases due to complete symptom relief, 2 cases due to adverse events, and 2 cases due to other reasons

Adverse events

A total of 21 corticosteroid-related adverse events were reported. No serious adverse events, gastrointestinal bleeding, or gastrointestinal perforation were observed.
Insomnia: 10 cases (Grade 2 or less: 10, Grade 3 or more: 0)
Delirium: 8 cases (Grade 2 or less: 7, Grade 3 or more: 1 [Grade 3])
Hyperglycemia: 3 cases (Grade 2 or less: 2, Grade 3 or more: 1 [Grade 3])
Other symptoms: 0 cases
Note: Adverse events were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. If the same adverse event occurred multiple times, only the highest severity grade was reported.

Outcome measures

Primary Outcome:
Changes in the worst and average pain intensity scores on a 0 to 10 Numerical Rating Scale (NRS) from baseline (T0) to 72 hours (T1) and 168 hours (T2).
Secondary Outcomes:

Pain Interference with General Activities: Change in pain interference scores (0 to 10 NRS).

Pain Interference with Sleep: Change in the Daily Sleep Interference Score (0 to 10 NRS).

Proportions of Pain Reduction: Proportions of patients achieving 33 percent, 50 percent, and 100 percent reduction in pain intensity.

Achievement of Personalized Pain Goals (PPG): The proportion of patients who achieved their target average pain level set at T0.

Patient Global Impression of Change (PGIC): Self-reported overall improvement rated on a 7-point scale (ranging from 0 for very much improved to 7 for very much worse).

Functional Status (AKPS): Changes in performance status via the AKPS (scored 0 to 100) and its correlation with pain intensity scores.

Analgesic Dosage and Correlations: Daily dose transition of corticosteroids and opioids, with its correlation to changes in pain intensity.

Corticosteroid-related Adverse Events: Frequency and severity of corticosteroid-related toxicities graded by CTCAE version 5.0.

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2020

Year

02

Month

03

Day

Date of IRB

2020

Year

02

Month

17

Day

Anticipated trial start date

2020

Year

06

Month

01

Day

Last follow-up date

2021

Year

12

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Prospective Observational Study
The patients who admit in the hospital from June 6 2020 to December 31 2021 are registered.

Registered date

2020

Year

05

Month

29

Day

Last modified on

2026

Year

06

Month

03

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046318