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Lymphoma, T-Cell, Cutaneous

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Lymphatic Diseases

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Cutaneous T-cell Lymphoma

All Drugs and Chemicals

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Herbal and Botanical

Turmeric extract

Curcumin

Anti-Inflammatory Agents, Non-Steroidal

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Protective Agents

Turmeric

Chew then swallow 2 sticks per day for up to 6 months.

2 sticks = 1 packet of curcumin = 8 grams

Curcumin (Turmeric)

Quality of life (QOL) questionnaires completed on Day 1, Weeks 2, 4, 8, 12, 16, 20, and at end of treatment visit.

Questionnaires

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.

Photos

Madeleine Duvic, MD

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:

* You will have a physical exam, including measurement of your vital signs.
* You will be asked to rate your itching on a scale of 0-10.
* You will complete the 2 quality-of-life questionnaires.
* The study staff will take photos of up to 6 selected skin lesion(s). These will be close-up photos of the lesions and a small area of surrounding skin. "Half-body" photos will also be taken. These will be front, back, and/or side views of the top and bottom half of your body, depending on where the lesions are. For the half-body photos, your private areas will be covered (as much as possible), and your face will not be included in the photos unless there are lesions there.
* Blood (about 3 teaspoons) will be drawn for routine tests
* You will complete 2 "quality-of-life" questionnaires that ask how the symptoms of the disease may be affecting your life. This should take about 5 minutes.
* You will have a physical exam, including having skin lesions and affected areas of your skin looked at by the study doctor.
* If the study doctor thinks it is needed, you will have a skin biopsy performed. To perform a skin biopsy, the area is numbed with anesthetic and a small amount of tissue (about the size of a pencil eraser) is removed with a special tool.

The following tests and procedures will be performed at Weeks 2, 4, 8, 12, 16, and 20:

* You will have a physical exam, including having skin lesions and affected areas of your skin looked at by the study doctor.
* You will complete the 2 quality-of-life questionnaires.
* Your vital signs will be measured.
* You will be asked to rate your itching on a scale of 0-10.

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:

* You will have a physical exam.
* You will be asked to rate your itching on a scale of 0-10.
* Blood (about 2 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.
* A skin biopsy will be performed to check the status of the disease.
* Photos of the skin lesion(s) will be taken.
* You will complete the 2 quality-of-life questionnaires.
* You will have a CT and/or PET scan to check the size of the lymph nodes.

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.

Trial of Curcumin in Cutaneous T-cell Lymphoma Patients

Phase II Trial of Curcumin in Cutaneous T-cell Lymphoma Patients

M.D. Anderson Cancer Center

Skin and Connective Tissue Diseases

Skin Neoplasms

Participants complete 1 questionnaire at beginning of study, 1 after receiving education about how to protect skin from sun and how to avoid tanning beds, and 1 at about 3 months after receiving skin protection education. Participants given handouts that discusses skin cancer prevention, sun protection, and how to avoid tanning beds. At beginning of study, 2 photos taken of the face. One photo is a standard photo, the other photo is taken with an ultraviolet (UV) filter.

Participants complete 1 questionnaire at beginning of study, 1 after receiving education about how to protect skin from sun and how to avoid tanning beds, and 1 at about 3 months after receiving skin protection education. Participants given handouts that discusses skin cancer prevention, sun protection, and how to avoid tanning beds.

Participants complete 1 questionnaire at beginning of study, 1 after receiving education about how to protect skin from sun and how to avoid tanning beds, and 1 at about 3 months after receiving skin protection education.

At beginning of study, 2 photos taken of the face. One photo is a standard photo, the other photo is taken with an ultraviolet (UV) filter.

At beginning of study, handouts given that discusses skin cancer prevention, sun protection, and how to avoid tanning beds.

Pamphlets

Susan Peterson, MPH,PHD

The goal of this research study is to learn how students react to seeing a photograph of any skin damage they may have on their face. This skin damage may be caused by sun exposure or use of tanning beds. Researchers also want to learn about students' sun protection, tanning behaviors, and attitudes towards sun exposure, sun protection, tanning behaviors and skin cancer.

Researchers will use the results of this study to design programs for students about sun protection and tanning avoidance.

If participant agrees to take part in this study, they will complete 3 questionnaires about sun protection, tanning behaviors, sunburns, and attitudes and opinions about sun exposure, sun protection, tanning behaviors and skin cancer.

Participant's school will be assigned to 1 of 2 possible groups:

* If participant's school is assigned to Group 1, they will have 2 photos taken of their face. One (1) photo is a standard photo (like the kind one may take with a regular camera). The other photo is taken with an ultraviolet (UV) filter and shows skin damage that cannot be seen in a standard photo.
* If participant's school is assigned to Group 2, they will not have any photos taken.

If participant is in Group 1, they and a member of the study staff will compare the standard and UV photographs together. The study staff will discuss any skin damage seen with participant. A member of the study staff will record on a paper form any visible reactions participant may have to viewing their UV photograph. Participant will also be given a handout that discusses skin cancer prevention, sun protection, and how to avoid tanning beds. Participant will see their photos on a computer screen. Participant will not be given their photos. At the end of this study, the photos will be deleted.

If participant is in Group 2, they will only receive a handout that discusses skin cancer prevention, sun protection, and how to avoid tanning beds.

All participants will complete 1 questionnaire at the beginning of the study (before receiving any kind of education about skin cancer prevention), 1 questionnaire after receiving education about how to protect participant's skin from the sun and how to avoid tanning beds, and 1 questionnaire at about 3 months after receiving the education about how to protect skin from the sun and how to avoid tanning beds.

Participant will complete these study procedures at school and they may answer some of the questionnaires outside of school. Participant will complete the first questionnaire on paper at their school. Participant will have an option to complete this questionnaire online if they are not able to complete it on paper the day the study team visits their school. Participant will complete the second questionnaire on paper at their school. Participant will complete the third questionnaire online. Links to the online questionnaires will be sent to the email address that participant will provide on the Participant Contact Information Form. Participant will also have an option to receive a link to the questionnaire via text message if they provide us with a cell phone number that can receive text messages on the Participant Contact Information Form. Participant may incur charges for receiving text messages.

Length of Study:

Student's participation in this study will be over after they have completed the last questionnaire. It will take about 1 hour to complete all study questionnaires and procedures.

This is an investigational study.

Up to 420 participants will be enrolled in this study. All will take part through MD Anderson at different schools in the greater Houston area.

Only about 35 participants will be able to take part at each school. This means that even if participant agrees, they may not be selected to take part in this study. The student participants will be randomly selected from the pool of students who agree to participate.

Ultraviolet (UV) Photography in Adolescents

Sun Protection, Tanning Behaviors and Attitudes in Adolescents

Baseline sun protection behaviors are assessed using self-reported measures of sun protection behaviors. Both the baseline and 3-month behavior composite scores range from 1 to 5 and are calculated as the mean of the four sun protection behavior items.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Trial of Curcumin in Cutaneous T-cell Lymphoma Patients	NCT00969085	Cutaneous T-cel...	Curcumin (Turme... Questionnaires Photos	-	M.D. Anderson Cancer Center
Ultraviolet (UV) Photography in Adolescents	NCT02426853	Cancer Preventi...	Questionnaires Photos Pamphlets	12 Years - 14 Years	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for photos

Every month we try and update this database with for photos cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for photos

Every month we try and update this database with for photos cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for photos cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.