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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether ketorolac, a common pain reliever, can help people with pancreatic cancer maintain or increase their weight and improve their quality of life. Researchers aim to determine its safety and effectiveness for patients experiencing weight loss due to their illness. People with advanced pancreatic cancer and significant weight loss, receiving treatment at Cedars-Sinai Medical Center, might be suitable candidates. Participants need WiFi access for a Smart Scale to track progress. As an Early Phase 1 trial, this research focuses on understanding how ketorolac works in people, offering participants a chance to contribute to groundbreaking research.

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.

Is there any evidence suggesting that ketorolac is likely to be safe for humans?

Research shows that ketorolac, the drug under study, is generally well-tolerated as a nonsteroidal anti-inflammatory drug (NSAID). These medications often relieve pain and swelling. Studies have found that using ketorolac for short periods, such as the five days planned in this trial, has not raised major safety concerns.

Although ketorolac is not yet approved specifically for treating cachexia (a condition causing severe weight loss and muscle wasting) in pancreatic cancer, it is approved for other uses, indicating a certain level of safety in humans. However, since this study is in an early stage, researchers are still learning about its safety for this specific use. Participants should discuss the possible risks and benefits with their healthcare providers. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for cachexia in pancreatic cancer, which often involve nutritional support and appetite stimulants, Ketorolac Tromethamine offers a different approach. Ketorolac is unique because it is a non-steroidal anti-inflammatory drug (NSAID) that may help reduce inflammation, potentially addressing the underlying causes of cachexia rather than just the symptoms. Researchers are excited about this treatment because it could offer a faster and more direct way to improve patients' quality of life by mitigating the muscle wasting and weight loss that characterize cachexia. Additionally, its fast-acting nature means it might show results in just a few days, which is crucial for patients with advanced cancer.

What evidence suggests that ketorolac might be an effective treatment for cachexia in pancreatic cancer?

Research has shown that ketorolac, a pain relief medication, might help with weight issues in pancreatic cancer. In earlier studies, patients using ketorolac lost less weight compared to those not using it. Another study found that R-ketorolac, a version of the drug, reduced weight loss in a cancer model without affecting food intake or tumor size. This trial will evaluate ketorolac's potential to stabilize weight and improve quality of life for those with pancreatic cancer cachexia, a condition characterized by weight and muscle loss. While more research is needed, these findings are promising for managing weight loss in pancreatic cancer patients. ^{2 4 6 7 8}

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. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.4_suppl.713

Effect of ketorolac on serum GDF-15 and IL-8 in patients ... This abstract focuses on the exploratory endpoints (serum GDF-15 and IL-8 levels) of a feasibility trial on ketorolac as a treatment for PC cachexia.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10995265/

R‐ketorolac ameliorates cancer‐associated cachexia and ... R‐ketorolac treatment prolongs survival and alleviates C26‐induced weight loss independent of tumour growth and food intake. To study the effects of RK ...

3. aacr.org aacr.org/blog/2024/11/14/understanding-and-treating-pancreatic-cancer-cachexia/

Understanding and Treating Pancreatic Cancer Cachexia While patients who received the intervention did not gain weight during the trial, they lost significantly less weight than patients receiving ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2949928325000446

Pancreatic cancer cachexia: A systemic consequence of ... Another study found that pancreatic head tumors were associated with a higher prevalence and degree of weight loss than distal tumors [25].

5. withpower.com withpower.com/trial/early-phase-1-pancreatic-neoplasms-7-2022-f199a

Ketorolac for Cachexia in Pancreatic Cancer 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 ...

6. ctv.veeva.com ctv.veeva.com/study/a-feasibility-study-of-ketorolac-treatment-for-cachexia-in-patients-with-advanced-pancreatic-ductal

A Feasibility Study of Ketorolac Treatment for Cachexia in ... The purpose of this study is to see if taking ketorolac, a nonsteroidal anti-inflammatory drug (NSAID), is reasonable, safe and can ...

7. clinicaltrial.be clinicaltrial.be/en/details/29431?per_page=100&only_recruiting=0&only_eligible=0&only_active=0

A Feasibility Study of Ketorolac Treatment for Cachexia i... The main things that will happen in this study are: patients will be administered ketorolac for 5 days, blood draws, completion of ...

8. medrxiv.org medrxiv.org/content/10.1101/2025.03.14.25323917v3.full.pdf

Landscape of Clinical Trials in Cancer Cachexia NCT00219817. Completed w/ Results. Safety and Efficacy of RC-1291 HCl in Patients with Cancer Related Anorexia and Weight Loss. NCT00267358.