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The goal of this clinical research study is to learn if treatment with curcumin can help to decrease the size of lesions and/or decrease itching in patients with MF or SS. The safety of curcumin will also be studied.
Curcumin:
Curcumin, a yellow substance taken from a plant, is commonly used in cooking as a spice called turmeric. In this study, participants will receive much higher doses of curcumin than can be received through food.
Curcumin may block proteins that help cells to divide. These proteins also may stop cancer cells from dying.
Study Drug Administration:
If you are found to be eligible to take part in this study, you will swallow 2 sticks of curcumin per day. You should take the 2 sticks each morning with food and enough water for you to be able to swallow them. If you miss taking a dose of curcumin in the morning, you can take it later that day (as soon as you remember). However, if you miss a dose all day, do not take 2 doses the next day to make up for it.
Study Visits:
You will be asked to return for study visits.
At "baseline" (Day 1), the following tests and procedures will be performed:
The following tests and procedures will be performed at Weeks 2, 4, 8, 12, 16, and 20:
At Weeks 2, 4, and 12 only, the following additional test will be performed:
-Just like at baseline, you will have skin lesion photos and half-body photos taken.
At Weeks 4, 12, and 20 only, the following additional test will be performed:
-Blood (about 3 teaspoons) will be drawn for routine tests.
If the doctor decides it is needed based on abnormal blood tests at screening, additional blood (about 1 teaspoon) will be drawn to check the status of the disease at Weeks 2, 4, 8, and 12.
If at any time during the study the skin disease seems to have cleared, you will have a skin biopsy performed in order to confirm the response.
Length of Study Participation:
You may continue receiving the study drug for up to 6 months, as long as you and the study doctor think you are benefitting from taking curcumin. If the disease gets worse or intolerable side effects occur at any time during this study, you will be taken off study.
End-of-Treatment Visit:
When you go off study for any reason, you will have an end-of-treatment visit. The following procedures will be performed:
Follow-Up:
Every 3 months for 6 months after your last dose of the study drug, the study staff will check the results of any routine tests that were performed at your regular follow-up visits for MF or SS. If you do not visit the clinic during one or both of these two 3-month time periods, you will be called at home at 3 months and/or 6 months after your last dose of the study drug. The purpose of the phone calls is to ask how you are doing.
This is an investigational study. Curcumin is not FDA approved or commercially available for the treatment of cutaneous T-cell lymphoma. For this purpose, it is being used in research only.
Up to 20 patients will take part in this study. All will be enrolled at M. D. Anderson.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Curcumin | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Curcumin (Turmeric) | Drug | Chew then swallow 2 sticks per day for up to 6 months. 2 sticks = 1 packet of curcumin = 8 grams |
|
| Measure | Description | Time Frame |
|---|---|---|
| Response Rate using Physician's Global Assessment (PGA) based on Severity-Weighted Assessment Tool (SWAT) | Assessed every 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Madeleine Duvic, MD | UT MD Anderson Cancer Center | Study Chair |
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| Label | URL |
|---|---|
| UT MD Anderson Cancer Center website | View source |
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| ID | Term |
|---|---|
| D016410 | Lymphoma, T-Cell, Cutaneous |
| D009182 | Mycosis Fungoides |
| D012751 | Sezary Syndrome |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D003474 | Curcumin |
| D011795 | Surveys and Questionnaires |
| D009040 | Motion Pictures |
| ID | Term |
|---|---|
| D036381 | Diarylheptanoids |
| D006536 | Heptanes |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
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| Questionnaires | Behavioral | Quality of life (QOL) questionnaires completed on Day 1, Weeks 2, 4, 8, 12, 16, 20, and at end of treatment visit. |
|
|
| Photos | Other | Photos of up to 6 selected skin lesion(s) and half-body photos taken on Day 1, Weeks 2, 4, 12, and at end of treatment visit. |
|
|
| D009369 |
| Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D001296 | Audiovisual Aids |
| D018961 | Educational Technology |
| D013672 | Technology |
| D013676 | Technology, Industry, and Agriculture |