Ketorolac for Cachexia in Pancreatic Cancer

(KetoROCX Trial)

Overseen By Arsen Osipov

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Andrew Hendifar, MD

Must not be taking: NSAIDs

Disqualifiers: Infection, Heart failure, Angina, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 1 week

28 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing if ketorolac, a drug that reduces pain and swelling, can help pancreatic cancer patients maintain or gain weight and feel better overall. Ketorolac has been used effectively for pain management in various surgical procedures, including in children and infants.

Will I have to stop taking my current medications?

The trial requires that you stop taking any other NSAIDs (nonsteroidal anti-inflammatory drugs) while participating. For other medications, the protocol does not specify, so it's best to discuss with the study team.

How does the drug Ketorolac Tromethamine differ from other treatments for cachexia in pancreatic cancer?

Ketorolac Tromethamine is unique because it is a nonsteroidal anti-inflammatory drug (NSAID) that may help manage cachexia by reducing inflammation, which is a different approach compared to other treatments like progestagens or ghrelin receptor agonists that focus on appetite stimulation and weight gain. ^{1 2 3 4 5}

Who Is on the Research Team?

Andrew Hendifar, MD

Principal Investigator

Cedars-Sinai Medical Center

Are You a Good Fit for This Trial?

This trial is for adults with advanced pancreatic cancer and cachexia, which means they've lost a lot of weight due to illness. They need good kidney function, internet access for a Smart Scale, and an ECOG performance status ≤2 or Karnofsky >50%. Pregnant women or those at risk of bleeding can't join.

Inclusion Criteria

I can take care of myself but might not be able to do heavy physical work.

I have advanced pancreatic cancer that has not responded to treatment and am referred to Cedars-Sinai.

My kidney function, measured by creatinine levels or filtration rate, is within the required range.

Exclusion Criteria

I am at high risk of bleeding or bruise easily.

Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator

I am not taking any other NSAIDs while participating in this study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants receive Ketorolac four times a day for up to five days

1 week

Daily monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including changes in weight, activity, and quality of life

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Ketorolac Tromethamine

Trial Overview The study tests if ketorolac, an anti-inflammatory drug, is safe and effective in stabilizing or increasing the weight and improving quality of life in patients with advanced pancreatic cancer who are experiencing significant weight loss.

How Is the Trial Designed?

Group I: Ketorolac (open label) Experimental Treatment 1 Intervention

Pancreatic patients receiving Ketorolac four times a day for up to five days

Ketorolac Tromethamine is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Toradol for:

• Moderate to severe pain
• Rheumatoid arthritis
• Osteoarthritis
• Ankylosing spondylitis
• Menstrual disorders
• Headaches

Approved in European Union as Ketorolac for:

• Moderate to severe pain
• Rheumatoid arthritis
• Osteoarthritis
• Ankylosing spondylitis
• Menstrual disorders
• Headaches

Approved in Canada as Ketorolac for:

• Moderate to severe pain
• Rheumatoid arthritis
• Osteoarthritis
• Ankylosing spondylitis
• Menstrual disorders
• Headaches

Who Is Running the Clinical Trial?

Andrew Hendifar, MD

Lead Sponsor

Trials

6

Recruited

130+

Yinuoke Ltd.

Collaborator

Trials

1

Recruited

30+

Published Research Related to This Trial

Progestagens are currently the most effective and approved treatment for cancer-related cachexia in Europe, while several other proposed treatments have proven ineffective or inconclusive in clinical trials.

A multimodal approach that combines different therapies is suggested to be more effective in managing cancer-related cachexia due to its complex and multifactorial nature.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of cachexia in oncology. Tazi, E., Errihani, H.[2022]

In a trial comparing treatments for cancer anorexia/cachexia, megestrol acetate and dexamethasone both effectively enhanced appetite, but megestrol acetate showed a trend towards better outcomes in weight gain and appetite improvement.

Dexamethasone had a higher rate of side effects leading to treatment discontinuation compared to megestrol acetate, which also had a higher risk of deep venous thrombosis, indicating that while both medications are effective, their safety profiles differ significantly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized comparison of megestrol acetate versus dexamethasone versus fluoxymesterone for the treatment of cancer anorexia/cachexia. Loprinzi, CL., Kugler, JW., Sloan, JA., et al.[2017]

Citations

1. Japan pubmed.ncbi.nlm.nih.gov

Impact of the Extent of Weight Loss before Administration on the Efficacy of Anamorelin in Advanced Pancreatic Cancer Patients with Cachexia. [2023]

2. Ireland pubmed.ncbi.nlm.nih.gov

Naproxen, clenbuterol and insulin administration ameliorates cancer cachexia and reduce tumor growth in Walker 256 tumor-bearing rats. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Treatment of cachexia in oncology. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Effect of a fish oil-enriched nutritional supplement on metabolic mediators in patients with pancreatic cancer cachexia. [2013]

5. United States pubmed.ncbi.nlm.nih.gov

Randomized comparison of megestrol acetate versus dexamethasone versus fluoxymesterone for the treatment of cancer anorexia/cachexia. [2017]