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Efficacy of Non-opioid Drugs in Addition to Opioid Therapy for Cancer Pain Management

ConditionsCancer PainCancer Palliative Care
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Basel, Switzerland

About this trial

The investigators investigate the efficacy of non-opioid analgesics compared to placebo together with opioid therapy for cancer pain management.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Inpatient setting (discharge possible, if patient returns for End of Study Visit)

Diagnosis of metastatic or locally advanced cancer

Cancer pain as defined by IASP (International Association for the Study of Pain)

Cancer pain therapy with opioids indicated for pain management or start thereof at baseline (drug, dose, and route at treating physician's discretion)

Disqualifiers

History of allergy or allergy-like symptoms (bronchospasm, urticaria or severe cutaneous adverse reactions (SCARs)) or hypersensitivity to dipyrone (or other pyrazolones or pyrazolidines) or ibuprofen (or other Non-steroidal anti-inflammatory drug incl. acetylsalicylic acid)

Moderate to severe renal insufficiency (creatinine-eGFR (estimated Glomerular Filtration Rate) <45 ml/min)

Severe heart failure (New York Heart Association class III-IV)

Severe hepatic impairment (liver cirrhosis with ascites) or hepatic porphyria

Trial design

Design model

Parallel

Treatments tested in this trial

  • Metamizole

    Drug

    Metamizole 4 g/d as: 2 capsules of 500 mg Metamizole each (1000 mg) taken 4 x daily orally.

  • Ibuprofen

    Drug

    Ibuprofen 1.2 g/d as: 2 capsules of 150 mg Ibuprofen each (300 mg) taken 4 x daily orally

  • Placebo

    Other intervention

    Placebo 0 g/d as: 2 capsules containing inactive substance (mannitol) taken 4 x daily orally.

Treatment groups

318 Participants
are divided into 3 treatment groups
Group A: Opioid + MetamizoleExperimental treatment 1 intervention
Group B: Opioid + IbuprofenExperimental treatment 1 intervention
Group C: Opioid + PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in cancer pain

The primary outcome will help to determine whether adding metamizole (dipyrone) or ibuprofen to opioids is more effective than adding placebo in reducing average daily pain intensity (primary outcome) in cancer patients. \- Average of 5-day average daily patient reported pain assessed on days 3 to 7 by numeric rating scale (NRS); The NRS ranges from 0 ("no pain") to 10 ("pain as bad as the patient can imagine")

Time frame
up to 5 days

Secondary outcomes

1

Assessment of equivalence of metamizole and ibuprofen in analgesic potency regarding the pain intensity

Our main secondary outcome will help to investigate whether metamizole and ibuprofen demonstrate similar analgesic potency (are equivalent) regarding the pain intensity. For assessment of equivalence, Average of 5-day average daily patient reported pain assessed on days 3 to 7 by numeric rating scale will be used.

Time frame
up to 5 days
2

Worst pain in the past 24 hours by NRS

This outcome will be assessed at baseline and daily from day 3 to 7 using item 3 of the BPI-SF (Brief Pain Inventory - Short Form). The NRS ranges from 0 ("no pain") to 10 ("pain as bad as the patient can imagine"). It will also be assessed at End of Study Visit (EOS).

Time frame
up to 8 days
3

Least pain in the past 24 hours by NRS

This outcome will be assessed at baseline and daily from day 3 to 7 using item 4 of the BPI-SF. The NRS ranges from 0 ("no pain") to 10 ("pain as bad as the patient can imagine"). It will also be assessed at EOS.

Time frame
up to 8 days
4

Daily differences in pain intensity measured by NRS

This outcome will be assessed daily from day 3 to day 7 to investigate efficacy over the course of time. The NRS ranges from 0 ("no pain") to 10 ("pain as bad as the patient can imagine")

Time frame
up to 7 days

Other outcomes

1

Number of patients with ≥30% reduction in pain

For this outcome, the number of patients achieving ≥30% reduction in pain will be assessed, comparing pain at baseline (BL-pain) to the daily average pain on the last day of the intervention (day 7)

Time frame
up to 7 days
2

Adherence to protocol and IMP intake

Discharge during d1-d7 will be assessed (Yes/No), including time to discharge after inclusion, if applicable. IMP intake (i.e., missed doses day d1-d7) will be assessed daily.

Time frame
up to 7 days
3

Number of participants that opened the capsules

Administration assessed daily as "Capsules opened: Yes/No".

Time frame
up to 8 days
4

Number of participants that received the IMP through an enteral tube

Assessed daily as "Administration through enteral tube": Yes/No, if "capsules opened: Yes"

Time frame
up to 8 days

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Basel, Switzerland

Lead sponsor

Swiss GO Trial Group

Collaborator

Swiss National Science Foundation

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: