NCT03474406

The Effectiveness of Cancer Pain Management in Siriraj Outpatient Pain Clinic

Completed Results posted Last updated 16 March 2021

What this trial tests

trial testing follow up system and multimodality approach in Pain, Chronic in 150 participants. Completed in 30 June 2019.

Timeline

3 January 2018

Primary endpoint
30 March 2019

30 June 2019

Quick facts

Lead sponsor	Mahidol University
Status	Completed
Study type	OBSERVATIONAL
Enrollment	150
Start date	3 January 2018
Primary completion	30 March 2019
Estimated completion	30 June 2019
Sites	1 location across Thailand

Drugs / interventions tested

• follow up system and multimodality approach

Conditions studied

• Pain, Chronic — all drugs for Pain, Chronic →
• Cancer — all drugs for Cancer →

Sponsor

Mahidol University

Who can join

18 and older, any sex, with Pain, Chronic or Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Improvement of Pain. Primary · Approximately 12 wks from the baseline

Numerical Pain Rating Scale Total score 0-10 (0 is best outcome, 10 is worst outcome) 0-3 is mild pain, 4-7 is moderate pain, 7-10 is severe pain.

Group	Value	95% CI
Cancer Patients	3	1 – 5

Total Brief Pain Inventory (BPI) Secondary · Approximately 12 wks from the baseline

To assess the severity of pain and impact on functioning that included worst pain in last 24 hrs, least pain in last 24 hrs, pain average, pain right now, general activity, mood, walking ability, normal work, relationship with other, sleep and enjoyment of life. Each symptoms scales 0-10 (0 mean no symptom, not interfere, 10 mean most symptom, most interfere) total 70 scores

Group	Value	95% CI
Cancer Patients	26	8.5 – 40.5

Edmonton Symptom Assessment System(ESAS) Secondary · Approximately 12 wks from the baseline

To assess multi-directional of patients quality of life, included 9 symptoms ( pain,tired, neausea, depress, anxious, drowsiness, appetite, feeling of well being, shortness of breath) Each symptoms scales 0-9 (0 mean no Symptom, 9 mean most severe symptom) total ESAS 90 scores

Group	Value	95% CI
Cancer Patients	23.5	10.5 – 36.5

Percentage of Moderate to Severe Sedation Secondary · Approximately 12 wks from the baseline.

Pasero Opioid-induced Sedation Scale (POSS) * S=sleep, easy to arouse * 1=awake/alert * 2= slight drowsy/easy aroused * 3=Frequently drowsy, arousable, drifts off to sleep during conversation * 4=Somnolent, minimal or no response to verbal and physical stimulation Score of 2-4 indicated moderate to severe sedation

Group	Value	95% CI
Cancer Patients	6

Percentage of Moderate to Severe Neausea and Vomitting Secondary · Approximately 12 wks from the baseline

Four points scale to evaluate opioid induce nausea and vomiting Total scales 0-3 (0 is best outcome, 3 is worst outcome) * 0= no nausea and vomiting * 1= mild symptom but not need any treatments. (only neausea) * 2= moderate symptom, need treatment, can control symptom. (have vomiting can control with medication) * 3= severe symptom, need treatment, cannot control symptom. (vomiting can not control with medication)

Group	Value	95% CI
Cancer Patients	9

Percentage of Moderate to Severe Constipation Secondary · Approximately 12 wks from the baseline

Stool free interval 72 (sfi72) to evaluate opioid induce costipation (OIC): 0-4. Total scale 0-4 (0 is best outcome, 4 is worst outcome) * 0 represented one defecation within the previous 72 hr * 1 denoted mild constipation (no defecation within the last 72 h) * 2 referred to the use of a maximum of 3 laxatives * 3 referred to the use of more than 3 laxatives * 4 referred to the use of all laxatives have failed Score of 2-4 indicated moderate to severe constipation

Group	Value	95% CI
Cancer Patients	17

Percentage of Satisfied With the Service (Score=3) Secondary · Approximately 12 wks from the baseline.

Satisfied score * 1=Dissatisfied * 2=Neutral * 3=Satisfied

Group	Value	95% CI
Cancer Patients	64

Adverse events — posted to ClinicalTrials.gov

Time frame: We collected the adverse effect from pain medication such as sedation score, nausea and vomiting, constipation. from the baseline, FU1, FU2, FU3 (approximately 2-4 weeks eash interval) total 12 weeks.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Cancer Patients

Serious: 0/128 (0%)

Deaths: 28/128

Other adverse events (3 terms — click to expand)

Reaction	System	Cancer Patients
moderate to severe constipation	Gastrointestinal disorders	—
Moderate to severe nausea and vomiting	Gastrointestinal disorders	—
Moderate to severe sedation	Nervous system disorders	—

Data from ClinicalTrials.gov NCT03474406 adverse events section.

Sponsor's own description

-Background: Cancer is one of the most common cause of death. Cancer pain is often cited as one of the most feared in cancer patients. Although, WHO guidelines have been provided to improve pain outcome, the results are still unsatisfied. In order to improve cancer pain management we consider to contribute a new guideline which includes interdisciplinary approach, early doing the pain interventions, breakthrough pain, education, high quality of pain assessment and contribute the effectiveness follow-up system

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The Effectiveness of Cancer Pain Management in a Tertiary Hospital Outpatient Pain Clinic in Thailand: A Prospective Observational Study.
   Wangnamthip S, Panchoowong S, Donado C, Lobo K, et al · · 2021 · cited 2× · PMID 34336068 · DOI 10.1155/2021/5599023