Curcumin for Joint Pain in Breast Cancer Survivors

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether curcumin, a natural ingredient in turmeric, can reduce joint pain in breast cancer survivors experiencing joint issues from aromatase inhibitors (a type of cancer treatment). Participants will take either curcumin or a placebo (a non-active substance) to determine any noticeable difference in pain relief. Women who have experienced joint pain for at least three months while on aromatase inhibitors and have completed breast cancer surgery might be suitable for this study. As an unphased trial, this study offers participants the chance to contribute to research that could enhance the quality of life for breast cancer survivors.

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.

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

Research has shown that curcumin is generally safe for use. Studies have found that taking up to 12 grams daily for three months does not cause major safety issues. Some research suggests curcumin may reduce inflammation and pain, prompting its study for joint pain relief. Most people tolerate it well, experiencing no significant side effects. Curcumin has also been tested for conditions like osteoarthritis, showing it might ease joint pain. Overall, evidence supports its safety when used as directed. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about curcumin for joint pain relief in breast cancer survivors because it offers a natural alternative to standard treatments like NSAIDs and corticosteroids, which can have significant side effects. Curcumin, the active ingredient in turmeric, is known for its anti-inflammatory properties and is being tested in a nanoemulsion form to enhance its absorption in the body. Unlike traditional medications, this approach may offer a gentler, more natural way to manage pain without the typical risks associated with long-term use of conventional drugs.

What evidence suggests that curcumin might be an effective treatment for joint pain in breast cancer survivors?

Research has shown that curcumin, a natural substance in turmeric, may help reduce joint pain, especially when inflammation causes it. Studies have found it can be helpful for managing pain in conditions like osteoarthritis, a common joint problem. For breast cancer survivors, treatments like aromatase inhibitors often cause joint pain. Curcumin's ability to reduce inflammation might help ease this pain. This trial tests a special form of curcumin called nanoemulsion, which might be absorbed better by the body, to determine its effectiveness. Participants in one arm of the trial will receive nanoemulsion curcumin, while those in another arm will receive a placebo. ^{1 2 4 5 6}

Who Is on the Research Team?

Lisa D Yee, MD

Principal Investigator

City of Hope Medical Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11062803/

Randomized placebo-controlled, double-blind clinical trial ... Curcumin, a bioactive polyphenolic substance, may help ameliorate inflammation-related conditions including osteoarthritis and pain.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03865992

NCT03865992 | Curcumin in Reducing Joint Pain in Breast ... This phase I trial studies how well curcumin works in reducing joint pain in patients who are breast cancer survivors and have joint disease caused by ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0753332224012897

Curcumin and nanodelivery systems: New directions for ... The review primarily emphasizes recent advancements in CUR-based nano-delivery systems for the treatment and diagnosis of breast cancer.

4. researchgate.net researchgate.net/publication/373513917_Curcumin_for_Aromatase_Inhibitor-Induced_Joint_Pain_in_Breast_Cancer_Survivors_-_The_CurPain_Trial_A_Randomized_Double-Blind_Phase_III_Multicenter_Clinical_Trial

(PDF) Curcumin for Aromatase Inhibitor-Induced Joint Pain ... This study protocol will determine whether curcumin supplementation reduces joint pain in breast cancer survivors under AIs therapy. Methods: ...

5. withpower.com withpower.com/trial/phase-breast-neoplasms-2-2019-caf49

Curcumin for Joint Pain in Breast Cancer Survivors This trial studies whether a special form of curcumin can reduce joint pain in breast cancer survivors who have pain from their cancer treatment.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38280052/

Randomized placebo-controlled, double-blind clinical trial of ... Curcumin, a bioactive polyphenolic substance, may help ameliorate inflammation-related conditions including osteoarthritis and pain.