Curcumin for Joint Pain in Breast Cancer Survivors

Recruiting at 3 trial locations

Age: Any Age

Sex: Female

Trial Phase: Academic

Sponsor: City of Hope Medical Center

Must be taking: Aromatase inhibitors

Must not be taking: Anticoagulants, Immunosuppressants

Disqualifiers: Anemia, Autoimmune, Cardiac, Infections, others

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 3 months

42 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial studies whether a special form of curcumin can reduce joint pain in breast cancer survivors who have pain from their cancer treatment. Curcumin, found in turmeric, is known for its anti-inflammatory effects. The trial aims to see if this natural substance can help these patients feel better. Curcumin, derived from turmeric, has been used in traditional medicine for centuries and has shown potential anticancer and anti-inflammatory properties in various studies.

Will I have to stop taking my current medications?

You will need to stop taking certain medications before joining the trial. Specifically, you cannot use certain pain medications, steroids, or supplements like curcumin within a specified time before the study. However, you must continue taking your aromatase inhibitor medication.

What data supports the effectiveness of the drug curcumin for joint pain in breast cancer survivors?

Research shows that curcumin, found in turmeric, has anti-inflammatory and pain-relieving properties, which have been effective in managing conditions like arthritis and knee osteoarthritis. This suggests it may help with joint pain in breast cancer survivors as well. ^{1 2 3 4 5}

Is curcumin safe for human use?

Curcumin, a compound found in turmeric, is generally considered safe for human use. It is approved as Generally Regarded as Safe by the US FDA and has an excellent safety profile, with no significant side effects reported in various studies. ^{6 7 8 9 10}

How does the drug curcumin differ from other treatments for joint pain in breast cancer survivors?

Curcumin is unique because it is a natural compound found in turmeric with anti-inflammatory and antioxidant properties, which may help reduce joint pain without the side effects often associated with conventional medications. It also has a history of use in traditional medicine for various inflammatory conditions, making it a novel option for managing joint pain in breast cancer survivors. ^{1 2 7 10 11}

Research Team

Lisa D Yee, MD

Principal Investigator

City of Hope Medical Center

Eligibility Criteria

This trial is for postmenopausal breast cancer survivors with joint pain due to aromatase inhibitors. Participants must have had surgery for estrogen/progesterone-positive breast cancer and been on FDA-approved aromatase inhibitors for at least 90 days, planning to continue them. They should have a history of joint pain starting or worsening with the therapy.

Inclusion Criteria

I have been on an FDA-approved aromatase inhibitor for at least 90 days and plan to continue.

I have completed surgery for breast cancer, either mastectomy or lumpectomy.

I am postmenopausal or on treatment to suppress my ovaries for taking AIs.

Exclusion Criteria

I have not used strong painkillers, except for NSAIDs or acetaminophen, in the last 14 days and won't during the study.

I haven't had cancer in the last 5 years, except for certain skin cancers, cervical cancer in situ, or early-stage cancers I've recovered from.

I have not started any new treatment for joint pain or stiffness in the last 30 days.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive nanoemulsion curcumin or placebo orally twice daily for up to 3 months

3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Curcumin

Trial Overview The study tests if curcumin can reduce joint pain in these individuals compared to a placebo. Curcumin is derived from turmeric and may help arthritis-related discomfort. The trial includes taking curcumin or placebo, quality-of-life assessments, and questionnaires about the effect on joint pain.

Participant Groups

Group I: Arm I (nanoemulsion curcumin) Experimental Treatment 4 Interventions

Patients receives nanoemulsion curcumin orally (PO) twice daily (BID) for up to 3 months in the absence of disease progression or unacceptable toxicity.

Group II: Arm II (placebo) Placebo Group 1 Intervention

Patients receive placebo PO BID for up to 3 months in the absence of disease progression or unacceptable toxicity.

Curcumin is already approved in United States, European Union, India, China for the following indications:

Approved in United States as Curcumin for:

• Dietary Supplement

Approved in European Union as Curcuma for:

• Herbal Medicinal Product

Approved in India as Haldi for:

• Traditional Medicine

Approved in China as Jiang Huang for:

• Traditional Chinese Medicine

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials

614

Recruited

1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

Curcumin, the active compound in turmeric, has been shown to have multiple health benefits, including anti-inflammatory and anticancer properties, by regulating various proteins and enzymes involved in cell growth and survival.

Clinical trials indicate that curcumin is safe for consumption at high doses (up to 12g daily for 3 months) and may have therapeutic potential in treating a variety of diseases, including cancer, inflammatory bowel disease, and arthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Curcumin as "Curecumin": from kitchen to clinic. Goel, A., Kunnumakkara, AB., Aggarwal, BB.[2022]

In a pilot study involving 74 head and neck cancer patients undergoing radiotherapy, a 0.1% curcumin mouthwash significantly delayed the onset of radiation-induced oral mucositis (RIOM) by about 2 weeks compared to a 0.15% benzydamine mouthwash, with a 50% lower risk of developing RIOM.

While both mouthwashes were found to be equally effective in preventing severe forms of RIOM, neither was able to completely prevent its onset, indicating that curcumin may offer some benefits in managing this common side effect of radiotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of curcumin mouthwash on radiation-induced oral mucositis among head and neck cancer patients: A triple-blind, pilot randomised controlled trial. Shah, S., Rath, H., Sharma, G., et al.[2022]

CuminUP60®, a curcumin complex derived from Curcuma longa L., demonstrated no mutagenic effects in various safety studies, indicating it is safe for use.

In toxicity studies involving Sprague-Dawley rats, a single dose of 5000 mg was well tolerated, and the no observed adverse effect level (NOAEL) was established at 1000 mg/kg bw/day over a 4-week period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety evaluation of CuminUP60® - A novel curcumin complex. Dziwenka, M., Li, X., Li, W., et al.[2022]

Curcuma species, particularly C. longa, C. aromatica, and C. xanthorrhiza, are widely used in traditional medicine for treating various health issues, including indigestion and diabetes, due to their active compounds like curcumin.

Research from 1976 to 2008 highlights curcumin's significant anti-inflammatory, antioxidant, and potential anti-cancer properties, revealing its therapeutic mechanisms and genomic effects, which support its use in modern medicine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recent advances in the investigation of curcuminoids. Itokawa, H., Shi, Q., Akiyama, T., et al.[2022]

Quercetin-decorated liposomes containing curcumin showed improved effectiveness in increasing the lifespan and body weight of mice with Dalton's ascites lymphoma compared to liposomes without quercetin, indicating enhanced therapeutic potential.

The study demonstrated that these liposomes, with a particle size of approximately 261.8 nm, not only improved the cytotoxicity against cancer cells (HT-29 and HCT-15) but also addressed curcumin's limitations like poor solubility and short biological half-life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quercetin-Decorated Curcumin Liposome Design for Cancer Therapy: In-Vitro and In-Vivo Studies. Ravichandiran, V., Masilamani, K., Senthilnathan, B., et al.[2018]

Curcumin, the main active compound in turmeric, has demonstrated a wide range of beneficial effects, including anti-inflammatory, antioxidant, and anti-cancer properties, making it a promising treatment for various diseases.

The review highlights that curcumin has an excellent safety profile, suggesting it can be used effectively in managing conditions like arthritis, Alzheimer's, and other chronic diseases without significant risk of adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Comprehensive Review on Physiological Effects of Curcumin. Ahsan, R., Arshad, M., Khushtar, M., et al.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Curcumin as "Curecumin": from kitchen to clinic. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

Curcumin downregulates expression of opioid-related nociceptin receptor gene (OPRL1) in isolated neuroglia cells. [2022]

3. Ireland pubmed.ncbi.nlm.nih.gov

Curcuminoids inhibit human and rat placental 3β-hydroxysteroid dehydrogenases: Structure-activity relationship and in silico docking analysis. [2023]

4. India pubmed.ncbi.nlm.nih.gov

Research on curcumin: A meta-analysis of potentially malignant disorders. [2022]

5. India pubmed.ncbi.nlm.nih.gov

Effectiveness of curcumin mouthwash on radiation-induced oral mucositis among head and neck cancer patients: A triple-blind, pilot randomised controlled trial. [2022]

6. Ireland pubmed.ncbi.nlm.nih.gov

Safety evaluation of CuminUP60® - A novel curcumin complex. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Recent advances in the investigation of curcuminoids. [2022]

8. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Quercetin-Decorated Curcumin Liposome Design for Cancer Therapy: In-Vitro and In-Vivo Studies. [2018]

9. Germany pubmed.ncbi.nlm.nih.gov

A Comprehensive Review on Physiological Effects of Curcumin. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Role of curcumin in health and disease. [2022]

11. Thailand pubmed.ncbi.nlm.nih.gov

Curcumin: from food spice to cancer prevention. [2022]