Clinical Trial: Trial of Curcumin in Cutaneous T-cell Lymphoma Patients

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary:

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 l
    Sponsor: M.D. Anderson Cancer Center

    Current Primary Outcome: Response Rate using Physician's Global Assessment (PGA) based on Severity-Weighted Assessment Tool (SWAT) [ Time Frame: Assessed every 4 weeks ]

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    Original Secondary Outcome:

    Information By: M.D. Anderson Cancer Center

    Dates:
    Date Received: August 27, 2009
    Date Started: November 2012
    Date Completion:
    Last Updated: September 5, 2012
    Last Verified: September 2012