Table 2.
Clinical trials of phytochemicals for treatment of cancer.
| Molecule | Source | Clinical trial | Targeted population | Status | Highlights | Reference |
|---|---|---|---|---|---|---|
| Curcumin | Curcuma longa (Zingiberaceae) | Colon cancer | 18 years and, both sex | Terminated | A randomized, open label clinical trial was carried out to evaluate the effect on abnormalities in colon lining which might tend to adenocarcinoma Dose: 250 mg BID |
http://clinicaltrials.gov/show/NCT00176618 |
| In the lower gastrointestinal tract in Colon cancer | 18–85 years, both sex | Ongoing (Phase II) | A non-randomized, crossover, open labeled clinical trial was carried out on adenomatous polyps in colon cancer patients | http://clinicaltrials.gov/show/NCT00248053 | ||
| Curcumin in colon cancer for its Chemopreventive effect | 18 years and older, both sex | Ongoing (Phase II) | Randomized, Double Blind Placebo-Controlled Trial of Curcuminoids. Action of COX-2 Expression and Cellular Proliferation, Apoptosis in the Colorectal Mucosa of patients with currently Resected Sporadic Adenomatous Polyps Dose: 4 g |
http://clinicaltrials.gov/show/NCT00118989 | ||
| Curcumin in smokers with aberrant crypt foci in case of colon cancer | 40 years and older, both sex | Ongoing (Phase II) | Non-randomized open label trial to study how well curcumin works in controlling occurrence of colon cancer in smokers having aberrant crypt foci Dose: 2g, 4g. |
http://clinicaltrials.gov/show/NCT00365209 | ||
| To treat familial adenomatous polyposis in Intestinal cancer | 21 years to 85 years, both sex | Ongoing | Randomized, double blind trial of Curcumin in treatment of intestinal adenomas in Familial Adenomatous Polyposis (FAP) | http://clinicaltrials.gov/show/NCT00927485 | ||
| Curcumin for oral mucositis in children receiving doxorubicin based chemotherapy | 5–30 years, both sex | Ongoing (Phase III) | Randomized, single blind trial of curcumin for inhibiting Oral Mucositis in Children who are on Doxorubicin Based Chemotherapy. Dose: 5 ml |
http://clinicaltrials.gov/show/NCT00475683 | ||
| To control advanced high-grade osteosarcoma | 8–65 years, both sex | Ongoing (Phase I/II) | Non-randomized, open label trial for evaluation of Ashwagandha Root Powder Extract and Curcumin Formulation in the treatment of Advanced High-Grade Osteosarcoma | http://clinicaltrials.gov/show/NCT00689195 | ||
| To treat advanced pancreatic cancer | 18 years and older, both sex | Ongoing (Phase II) | Open label trial to see if curcumin treatment can help slow or shrink the growth of pancreatic cancers. The action of curcumin on the functioning of pancreatic cancer cells and the treatment safety Dose: 8 g |
http://clinicaltrials.gov/show/NCT00094445 | ||
| Curcumin in combination with gemcitabine in pancreatic cancer patients | 18 years and older, both sex | Ongoing (Phase II) | Non-randomized, open label trial to see if curcumin can improve the efficacy of the standard chemotherapy gemcitabine in advanced pancreatic cancer patients. Dose: 8 g |
http://clinicaltrials.gov/show/NCT00192842 | ||
| In treatment of metastatic colon cancer | 18 years and older, both sex | Not yet open (Phase III) | Randomized, double blind trial that evaluates curcumin and celecoxib in combination with gemcitabine for colon cancer patients. | http://clinicaltrials.gov/show/NCT00295035 | ||
| Andrographolide | Andrographis paniculata (Acanthaceae) | The safety and efficacy of Andrographolide in elderly patients with or without Capecitabine | 65 years and older, both sex | Phase 2 | Randomized, open label trial to evaluate the efficacy and safety of Andrographolides combined with Capecitabine in the treatment of elderly patients with locally advanced or recurrent or metastasis inoperable colorectal cancer. Dose : 500 mg |
http://clinicaltrials.gov/show/NCT01993472 |
| Ginsenoside Rg3 | Panax ginseng (Araliaceae) | Safety and efficacy of ginsenoside Rg3 in Hepatocellular Carcinoma stage I and II | 18–75 years, both sex | Completed | Randomized, double blind trial, to determine the safety and efficacy of ginsenoside Rg3 and placebo in prevention and treatment of postoperative recurrence of liver cancer, respectively. Dose : 20 mg |
http://clinicaltrials.gov/show/NCT01717066 |
| In advanced gastric cancer | 18–75 years, both sex | Phase2 | Randomized, double blind trial to evaluate the Ginsenoside Rg3 safety in advanced gastric cancer, and its effect on improvement in the efficacy of first-line chemotherapy. Dose : 20 mg |
http://clinicaltrials.gov/show/NCT01757366 | ||
| Parthenolide | Tanacetum parthenium (Asteraceae) | Dose escalation study in cancer patients | 18 years and older, both sex | Phase I | Non-randomized, open label trial was carried out to determine toxicity and pharmacokinetics of parthenolide. Dose : 1, 2, 3, 4mg |
Curry et al., 2004 |
| Thymoquinone | Nigella sativa (Ranunculaceae) | Toxicity in patients with hematological malignancies | 18 years and older, both sex | Phase I | Non-randomized, open label trial was carried to evaluate anti-cancer effects of the drug in advanced cancer and to evaluate general toxicities. Dose : 3, 7, 10 mg |
Al-Amri and Bamosa, 2009 |
| Resveratrol | Red wine | Effect of resveratrol in patients with colon cancer | 18 years and older, both sex | Completed | An interventional, randomized, open label clinical trial was carried out to determine the effects of resveratrol on the Wnt signaling pathway in a clinical trial of colon cancer patients. Dose: Plant-derived tablets: 80, 20 mg/day Grape powder: 120, 80 g/day |
http://clinicaltrials.gov/show/NCT00256334 |
| In treatment of Adenocarcinoma of the Colon Adenocarcinoma of the Rectum stage I and stage II | 18 years and older, both sex | Completed | Non-randomized, open label trial in patients with Colorectal cancer Patients to study its tolerability, Target Tissue Levels and Pharmacodynamics | http://clinicaltrials.gov/show/NCT00433576 | ||
| To treat Unspecified Adult Solid Tumor. | 18 years and older, both sex | Ongoing (Phase I-II) | Interventional open label trial to study the side effects and best dose of resveratrol in inhibiting cancer in healthy volunteers. | http://clinicaltrials.gov/show/NCT00098969 | ||
| Epigallocatechin-3-gallate | Tea, grapes and red wine | Evaluation of uateNCT the Chemopreventive Effects of Epigallocatechin gallate (EGCG) in Colorectal Cancer (CRC) Patients With Curative Resections | 18 years and older, both sex | Ongoing | Randomized, controlled pilot trial of patients with histological documentation of rectal adenocarcinoma or primary colon with resectable cancer, who have not gone through any cancer treatments Dose : 900, 450 mg |
http://clinicaltrials.gov/show/NCT02891538 |
| Quercetin | Buckwheat, Ginkgo biloba. | In treatment of Adenocarcinoma of the Prostate Recurrent Prostate Cancer stage I, IIA,IIB,III and IV | 40 to 75 years male | Ongoing (Phase I) | A Phase I Randomized, Double-Blind, Placebo-Controlled Two-Arm Study of Green Tea and Quercetin. | http://clinicaltrials.gov/show/NCT01912820 |
| In treatment of colon cancer | 18 years and older, both sex | Completed | Randomized clinical trial to study the effectiveness of sulindac, curcumin, rutin, and quercetin in preventing colon cancer. | http://clinicaltrials.gov/show/NCT00003365 | ||
| Apigenin | Onions, tea, parsley, wheat sprouts | In case of breast cancer | 18 years and older, both sex | Ongoing | Interventional clinical trial studies to determine the best dose and side effects of apigenin in increasing health benefits in patients of high-risk breast cancer. | http://clinicaltrials.gov/show/NCT03139227 |
| In treatment of colon cancer | 50–75 years, both sex | Ongoing (Phase II) | Randomized double blind clinical trial to evaluate that the dietary supplementation with bioflavonoids will inhibit the recurrence rate of colonic neoplasia. Dose : 20 mg |
http://clinicaltrials.gov/show/NCT00609310 | ||
| Indole-3-carbinol | Cruciferous vegetables | In case of breast cancer | 18–70 years female | Completed | Interventional, open label trial to study the efficacy of I3C in preventing breast cancer in women who are nonsmokers and are at high risk for breast cancer. | http://clinicaltrials.gov/show/NCT00033345 |
| Unspecified Adult Solid Tumor | 18–70 years, both sex | Completed | Randomized phase I trial is studying the best dose and side effects of I3C and to evaluate how well is it effective compared to placebo in inhibiting cancer in healthy participants. | http://clinicaltrials.gov/show/NCT00100958 | ||
| Ellagic acid | Strawberries, blackberries, walnuts, and raspberries | In treatment of colorectal cancer | 18 years and older, both sex | Completed | Randomized, single blind, trial of pomegranate extract formulations in colorectal cancer Patients to study metabolic and gene expression profiling in tumoral and normal Colon Tissues | http://clinicaltrials.gov/show/NCT01916239 |
| Diindolylmethane | Cruciferous vegetables | Pharmacokinetics and safety of diindolylmethane. | 18–70 years, both sex | Completed | Randomized, double blind clinical trials to study the side effects and best dose of diindolylmethane in preventing cancer in healthy volunteers. | http://clinicaltrials.gov/show/NCT00784394 |
| For breast cancer | 35–52 years female | Completed | Randomized, double blind trial to study the efficacy of DIM Supplements to enhance 2-OHE1/16 Ratio in Premenopausal Mexican Women With Risk of Breast Cancer Dose : 75 mg |
http://clinicaltrials.gov/show/NCT02525159 |