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Table 2 Examples of completed clinical trials related to cancer [77]

From: 3,3′-Diindolylmethane and indole-3-carbinol: potential therapeutic molecules for cancer chemoprevention and treatment via regulating cellular signaling pathways

Tested compound

Condition

Clinical Trial number

Dosage

Objective

Outcomes

I3C

Cancer

Clinical Trial-Phase 1- NCT00100958

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To study the side effects and best dose of I3C and to see how well it works compared to a placebo in preventing cancer in healthy participants.

No study results have been posted.

I3C

Breast Cancer

Clinical Trial-Phase 1- NCT00033345

400 mg daily for 4 weeks, followed by a 4-week period of 800 mg daily

To study the effectiveness of I3C in preventing breast cancer in nonsmoking women at high risk for breast cancer.

No study results have been posted.

DIM Supplement

Breast Cancer

Clinical Trial-Phase 3- NCT02525159

75 mg for 30 days

To evaluate the effectiveness of supplementation with DIM to increase the urinary ratio of estrogen metabolites 2 hydroxyestrone:16 alpha-hydroxyestrone

in premenopausal women at risk of breast cancer.

No study results have been posted.

Microencapsulated DIM (BioResponse-DIM)

Prostate Cancer

Clinical Trial-Phase 2- NCT00888654

225 mg twice daily for 14–72 days

To study how well DIM works in treating patients with stage I or stage II prostate cancer undergoing radical prostatectomy.

-A mean level of 14.2 ng/g of DIM was found in prostate tissue after treatment.

-The serum levels of PSA, testosterone, and DIM pre- and post-treatment were in ng/ml 6.4 and 5.8, 301 and 388 and 0.0 and 7.5, respectively.

-The levels of androgen receptor in prostate tissue (units: intensity x % cells stained) were 278 in pre-treatment and 245 and post-treatment.

-Two people out of 41 enrolled, presented headache, reported as a severe adverse event.

Microencapsulated DIM (BioResponse-DIM)

Cervical Dysplasia

Clinical Trial-Phase 3- NCT00212381

2 mg/kg/day

To determine if oral DIM, is associated with the regression of cervical dysplasia in otherwise healthy women.

No study results have been posted.

Brassica vegetables

Prostate Cancer

Clinical Trial - NCT00607932

At least 2 servings (½ cup/serving) daily for 6 months

To study the side effects and how well Brassica vegetable work compared with I3C in treating patients with PSA recurrence after surgery for prostate cancer.

No study results have been posted.