Symptoms and General Pathology

All Conditions

Neoplasms

Rare Diseases

Recurrence

Papilloma

Neoplasms, Squamous Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Laryngeal Papillomatosis

Antineoplastic Agents

All Drugs and Chemicals

3,3'-diindolylmethane

Protective Agents

once-time 585 nm pulsed dye laser (PDL) treatment on the lesions, immediately followed by 3-month oral taking diindolylmethane (DIM, at 1.2-1.75mg/kg/day), in 15 subjects

once-time PDL treatment on the lesions, then followed by 3-month oral taking DIM placebo, in other 15 subjects

diindolylmethane (DIM)

585 nm pulsed dye laser

Zhi Wang, MD

This study will determine efficacy of a new and combined treatment of laryngeal recurrent respiratory papillomatosis (RRP), by using a 585 nm pulsed dye laser (PDL) and a dietary supplement, diindolylmethane (DIM). We will compare this new treatment with PDL-only, in a total of 30 children (15 of each treatment), to determine whether this combined treatment would be effective and safe in preventing the RRP recurrence. This is the first study to combine PDL technique with DIM, to develop a new, voice-preserving and long-term effective method of managing laryngeal RRP in children.

Previous studies have demonstrated that PDL can be used to remove lesions on the vocal cords and elsewhere in the throat causing less damage to surface tissues than other commonly used lasers. In our proposed clinical study, we seek to compare treatment efficacy for RRP by combining PDL with DIM, versus PDL-only treatment, in a total of 30 children with laryngeal papilloma. We will determine whether this combined treatment would be effective and safe in preventing or delaying the RRP recurrence while preserving voice quality. 30 children will be divided randomly into two treatment groups, 15 in each. The experimental group will receive one-time PDL treatment, followed by 3-month oral administration of DIM and an additional 12 months with no treatment. The other group will be treated with PDL-only, as a control, and take a placebo pill for 3 months. All of the patients will be followed for a total of 15 months. We will compare lesion recurrence and laboratory tests between the two groups, to determine efficacy and safety of the new treatment. This is the first study to combine new PDL laser technique with DIM, to develop a new, voice-preserving and long-term effective method of managing laryngeal RRP in children.

laser only vs laser+ a dietary agent (DIM)

treatment to be selected based on a randomized number table, blinded to participants

New Therapy of Laryngeal Papilloma In Children

Voice Preserving Therapy of Laryngeal Papilloma In Children

no such meaningful data available due to insufficient recruitment

vocal lesion size and area after 5 month with surgery visible lesion found in \>50% of the treated tissue area, after surgery

determine side-effect by comparing Estradiol level in blood before and after treatment

National Institute on Deafness and Other Communication Disorders (NIDCD)

Boston University

Professor and Director

PDL+DIM Pill

once-time PDL treatment by PDL on the lesions, then followed by 3-month oral taking DIM placebo, in other 15 subjects

PDL+Placebo Pill

once-time 585 nm pulsed dye laser (PDL) treatment on the lesions, immediately followed by 3-month oral taking diindolylmethane (DIM, at 1.2-1.75mg/kg/day), in 15 subjects

diindolylmethane (DIM): 3-month DIM

585 nm pulsed dye laser: once-time PDL

once-time PDL treatment on the lesions, then followed by 3-month oral taking DIM placebo, in other 15 subjects

585 nm pulsed dye laser: once-time PDL

Total

Age, Categorical

Sex: Female, Male

United States

Region of Enrollment

There was only one participant due to difficulty in recruitment which resulted in early termination of the trial.

Intervention

Placebo

participants received at least one of two interventions

Number of Cases With Recurrence of Laryngeal Papilloma in 5 Months

failure for any meaningful analysis as only 1 participant in this study

Estradiol Level in Blood Pre Treatment

Estradiol Level in Blood Post Treatment

Overall Study

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Anticoagulants

Vasodilator Agents

Respiratory System Agents

Anticonvulsants

Estrogens

Warfarin

Theophylline

This group will have up to 100 women who are carriers of a BRCA1 deleterious mutation. To ensure safety, women in this group will not be able to participate in the study if they are under medications with warfarin, theophylline, or anticonvulsants; or if they are pregnant, breast-feeding or planning to become pregnant within 6 months of the research project. Women in this group will receive 300 mg per day of Rx Balance BioResponse DIM for six weeks. Supplements will be given free of charge. A blood sample (20cc) and a urine sample (20cc) will be collected from these women during two clinic visits; the second visit will be during the six weeks of DIM supplementation (4-6 weeks after the first clinic visit).

This group will have up to a 100 women who are carriers of a BRCA1 deleterious mutation. This group will not receive DIM. Women that choose not to take DIM will be in this group. A blood sample (20cc) and a urine sample (20cc) will be collected from these women during two clinic visits; the second visit will be 4-6 weeks after the first clinic visit.

This group will have up to 100 women who do not carry a BRCA1 mutation but who come from BRCA1 carrier family (a family with at least one individual that has tested positive for a BRCA1 mutation). A control subject is considered negative for a BRCA1 mutation if she has been confirmed by direct DNA sequencing to not be a carrier of this gene. A blood sample (20cc) and a urine sample (20cc) will be collected from these women at a single clinic visit.

Diindolylmethane (DIM)

Joanne Kotsopoulos, PhD

Marcia Llacuachaqui, HonBSc

Steven A Narod, MD

Women with a BRCA1 mutation face a lifetime risk of breast cancer of approximately 70% and a lifetime risk of ovarian cancer of approximately 40%. A number of potential anti-cancer nutrients have been proposed, however, it is important that diet supplements be evaluated prior to general recommendation.

The risk of breast and ovarian cancer in carriers of a BRCA1 mutation might be lowered by some nutritional supplements. For example, green tea, broccoli and vitamin D are of potential interest. One dietary supplement that is thought to have potential for BRCA1 carriers is diindolylmethane (DIM), which is an active ingredient in broccoli and other green vegetables. DIM - is found in vegetables like broccoli and is available as a supplement in health food stores. The investigators think that DIM may increase the production of the normal copy of BRCA1 and offset the effect of the mutation.

The purpose of this study is to determine that there is a potential for oral DIM supplementation to result in the increased production of the BRCA1 protein in BRCA1 mutation carriers. The results of the study will also serve as an evaluation of the current use and success of preventive strategies for BRCA1 mutation carriers.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
New Therapy of Laryngeal Papilloma In Children	NCT00591305	Papilloma	diindolylmethan... 585 nm pulsed d...	10 Years - 21 Years	Boston University
The Potential for Oral Diindolylmethane (DIM) Supplementation to Increase the Production of the BRCA1 Protein in BRCA1 Mutation Carriers	NCT01022333	Breast Cancer	Diindolylmethan...	25 Years - 45 Years	Women's College Hospital

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