Curcumin for Precancerous Anal Cells

Recruiting at 1 trial location

Overseen By Lisa Flowers, MD, MPH

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Lisa Flowers

Disqualifiers: Coronary disease, Congestive heart failure, Diabetes, others

No Placebo Group

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

The purpose of this study is to see if curcumin can reverse anal high-grade squamous intraepithelial lesions (aHSIL) (high-grade anal precancerous cells or high-grade abnormal cells) in people living with HIV to avoid current treatments such as ablation (destroying abnormal cells with heat or surgical excision (cutting out the abnormal cells)), which have potential short- and long-term side effects.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What evidence supports the effectiveness of the treatment Curcumin for precancerous anal cells?

Research shows that curcumin, the active ingredient in turmeric, has been studied for its anticancer properties, including its ability to inhibit cancer cell growth and spread. It has shown potential in treating various cancers, such as colorectal and breast cancer, by affecting cancer cell survival and inflammation. ^{1 2 3 4 5}

Is curcumin safe for human use?

Curcumin, the active ingredient in turmeric, is generally considered safe by the US FDA and has been used in traditional medicine for centuries. Clinical trials have shown it to be safe even at high doses of up to 12 grams per day for three months. ^{4 6 7 8 9}

How is curcumin different from other treatments for precancerous anal cells?

Curcumin, derived from turmeric, is unique because it has natural anti-cancer properties and has been used traditionally for various ailments. Unlike standard treatments, it may offer additional benefits like antioxidant and antimicrobial effects, making it a novel option for managing precancerous conditions. ^{1 2 5 10 11}

Research Team

Lisa Flowers, MD, MPH

Principal Investigator

Emory University

Eligibility Criteria

This trial is for individuals with HIV who have high-grade squamous intraepithelial lesions (aHSIL) in the anal area, which are precancerous cells. The study aims to help those seeking alternatives to current treatments like ablation or surgery that come with side effects.

Inclusion Criteria

Other inclusion criteria apply

Able and willing to complete Study Diary

My biopsy showed I have AIN 2 or AIN 3.

Exclusion Criteria

Have Grade 2 or higher renal or hematology abnormality

Other exclusion criteria apply

Pregnant or planning to become pregnant in the next three months

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive increasing doses of curcumin intra-anally for 14 days following a 3 + 3 dose escalation model

2 weeks

Daily administration

Follow-up

Participants are monitored for safety and effectiveness after treatment, including toxicity and anoscopy changes

2 weeks

Treatment Details

Interventions

• Curcumin (Cancer Vaccine)

Trial Overview The trial is testing whether curcumin, a natural compound often found in turmeric, can reverse aHSIL and prevent progression to cancer. Participants will receive curcumin treatment and be monitored for its effectiveness against these pre-cancerous cells.

Participant Groups

Group I: Dose Level 8 Experimental Treatment 1 Intervention

Participants will receive a supply of curcumin gelatin capsules to insert 4000 mg intra-anally every day for a 14-day treatment period

Group II: Dose Level 7 Experimental Treatment 1 Intervention

Participants will receive a supply of curcumin gelatin capsules to insert 3500 mg intra-anally every day for a 14-day treatment period

Group III: Dose Level 6 Experimental Treatment 1 Intervention

Participants will receive a supply of curcumin gelatin capsules to insert 3000 mg intra-anally every day for a 14-day treatment period

Group IV: Dose Level 5 Experimental Treatment 1 Intervention

Participants will receive a supply of curcumin gelatin capsules to insert 2500 mg intra-anally every day for a 14-day treatment period

Group V: Dose Level 4 Experimental Treatment 1 Intervention

Participants will receive a supply of curcumin gelatin capsules to insert 2000 mg intra-anally every day for a 14-day treatment period

Group VI: Dose Level 3 Experimental Treatment 1 Intervention

Participants will receive a supply of curcumin gelatin capsules to insert 1500 mg intra-anally every day for a 14-day treatment period

Group VII: Dose Level 2 Experimental Treatment 1 Intervention

Participants will receive a supply of curcumin gelatin capsules to insert 1000 mg intra-anally every day for a 14-day treatment period

Group VIII: Dose Level 1 Experimental Treatment 1 Intervention

Participants will receive a supply of curcumin gelatin capsules to insert 500 mg intra-anally every day for a 14-day treatment period

Curcumin is already approved in India, China for the following indications:

Approved in India as Haldi for:

• Traditional Medicine

Approved in China as Jiang Huang for:

• Traditional Chinese Medicine

Who Is Running the Clinical Trial?

Lisa Flowers

Lead Sponsor

Trials

4

Recruited

760+

Findings from Research

Curcumin, derived from turmeric, shows promise as an anticancer and anti-inflammatory agent based on various in-vitro and in-vivo studies, as well as clinical trials conducted from 2011 to 2015.

While curcumin formulations like nanoparticles and liposomes are being developed to improve its effectiveness, clinical trials have demonstrated its safety and tolerability, though the overall efficacy remains uncertain due to small sample sizes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An update on Curcuma as a functional food in the control of cancer and inflammation. Schaffer, M., Schaffer, PM., Bar-Sela, G.[2016]

The addition of 2 g of oral curcumin to FOLFOX chemotherapy was found to be safe and well-tolerated in a phase IIa trial involving 28 patients with metastatic colorectal cancer, with similar adverse event profiles between the two treatment groups.

Patients receiving curcumin alongside FOLFOX showed improved overall survival (502 days) compared to those on FOLFOX alone (200 days), although progression-free survival did not reach statistical significance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Curcumin Combined with FOLFOX Chemotherapy Is Safe and Tolerable in Patients with Metastatic Colorectal Cancer in a Randomized Phase IIa Trial. Howells, LM., Iwuji, COO., Irving, GRB., et al.[2023]

Curcumin and crocin, when used together, significantly reduce the viability of colorectal cancer cells (SW-480) and induce apoptosis by affecting key genes involved in cell death and proliferation.

The combination of these compounds not only promotes cell cycle arrest and autophagy but also decreases the ability of cancer cells to form new colonies, suggesting a promising therapeutic strategy against colorectal cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Synergistic anticancer effects of curcumin and crocin on human colorectal cancer cells. Hosseini, SS., Reihani, RZ., Doustvandi, MA., et al.[2022]

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]

Curcumin effectively inhibits the growth and spread of breast cancer stem-like cells (BCSCs) by reducing their ability to proliferate, migrate, and invade, as demonstrated in both MCF-7 and MDA-MB-231 cell lines.

The compound also alters the expression of key genes involved in epithelial-mesenchymal transition (EMT) and stem cell characteristics, suggesting that curcumin may serve as a promising anti-metastasis agent for breast cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anti-metastasis activity of curcumin against breast cancer via the inhibition of stem cell-like properties and EMT. Hu, C., Li, M., Guo, T., et al.[2019]

Curcumin, a natural compound from turmeric, has shown multiple beneficial properties including anti-inflammatory and anti-cancer effects, and it is considered safe even in high doses.

Recent studies suggest that curcumin can enhance the effectiveness of radiation therapy while also protecting normal tissues from radiation damage, making it a promising adjunct treatment in cancer therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Curcumins antineoplastic, radiosensitizing and radioprotective properties. Cihan, YB.[2022]

Curcuma longa, commonly known as turmeric, is a medicinal herb with a long history of use in traditional Chinese and Ayurvedic medicine for its anti-inflammatory properties and treatment of various ailments.

Current research highlights turmeric's potential health benefits, including its antioxidant, hepatoprotective, and antimicrobial effects, making it relevant for conditions like cardiovascular disease and gastrointestinal disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Curcuma longa (turmeric). Monograph. [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]

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]

The study identified 10 key components in turmeric extract, with major constituents including α-zingiberene and curcumin, which contribute to its potential health benefits.

Turmeric extract demonstrated significant anticancer activity, showing over 95% inhibition of cancer cell growth at a concentration of 250 µg/mL, particularly against HeLa and LX2 cell lines, indicating its promise as a natural cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chromatographic analysis of the chemical composition and anticancer activities of Curcuma longa extract cultivated in Palestine. Abualhasan, M., Jaradat, N., Hawash, M., et al.[2023]

Curcumin and its structural analogues (GO-Y030, FLLL-11, and FLLL-12) were tested on three human colorectal cancer cell lines, showing that the analogues were significantly more effective than curcumin in inhibiting cell viability, with IC50 values as low as 0.51 microM compared to curcumin's 10.26-13.31 microM.

The analogues also induced apoptosis more effectively than curcumin, indicated by increased levels of cleaved PARP and caspase-3, while demonstrating low toxicity to normal human lung fibroblasts, suggesting their potential as safer therapeutic options for colorectal cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New structural analogues of curcumin exhibit potent growth suppressive activity in human colorectal carcinoma cells. Cen, L., Hutzen, B., Ball, S., et al.[2022]

References

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

An update on Curcuma as a functional food in the control of cancer and inflammation. [2016]

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

Curcumin Combined with FOLFOX Chemotherapy Is Safe and Tolerable in Patients with Metastatic Colorectal Cancer in a Randomized Phase IIa Trial. [2023]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Synergistic anticancer effects of curcumin and crocin on human colorectal cancer cells. [2022]

4. England pubmed.ncbi.nlm.nih.gov

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

5. Germany pubmed.ncbi.nlm.nih.gov

Anti-metastasis activity of curcumin against breast cancer via the inhibition of stem cell-like properties and EMT. [2019]

6. Czech Republic pubmed.ncbi.nlm.nih.gov

Curcumins antineoplastic, radiosensitizing and radioprotective properties. [2022]

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

Curcuma longa (turmeric). Monograph. [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. England pubmed.ncbi.nlm.nih.gov

Recent advances in the investigation of curcuminoids. [2022]

10. Poland pubmed.ncbi.nlm.nih.gov

Chromatographic analysis of the chemical composition and anticancer activities of Curcuma longa extract cultivated in Palestine. [2023]

11. England pubmed.ncbi.nlm.nih.gov

New structural analogues of curcumin exhibit potent growth suppressive activity in human colorectal carcinoma cells. [2022]