Curcumin for the Prevention of Radiation-induced Dermatitis in Breast Cancer Patients

• ClinicalTrials.gov Identifier: NCT01042938
• Recruitment Status: Completed
• First Posted: January 6, 2010
• Results First Posted: June 20, 2012
• Last Update Posted: June 25, 2012
• Sponsor: University of Rochester
• Information provided by (Responsible Party): Julie Ryan, University of Rochester

Study Description

Brief Summary:

Ionizing radiation is a toxic agent and widely accepted form of treatment for various types of cancer. Despite advances in medical technology, radiation therapy still causes severe early and late skin effects. Radiation-induced dermatitis occurs in approximately 80% of patients. Important consequences of radiation-induced dermatitis include impairment of the quality of a patient's life due to pain and premature interruption of radiation treatment, which in turn, may be impair good local control of disease. The biological pathways responsible for acute radiation-induced dermatitis remain unclear. Currently, there is no standard treatment for the prevention of radiation-induced dermatitis with demonstrated effectiveness. The aim of this randomized, double-blind, placebo-controlled pilot study is to assess the effectiveness of curcumin for the prevention of acute radiation-induced dermatitis during postoperative radiotherapy for breast cancer. We hypothesize that curcumin, a natural phenolic compound found in both turmeric and curry powders, can prevent or alleviate radiation-induced skin reactions in breast cancer patients receiving radiotherapy.

Condition or disease	Intervention/treatment	Phase
Breast Cancer	Drug: Curcumin C3 Complex; Drug: Placebo	Phase 2

Detailed Description:

Specifically, this clinical pilot study will develop data necessary to calculate a sample size for a larger study to be conducted through the National Cancer Institute (NCI) Community Clinical Oncology Program (CCOP) mechanism. Specifically, this pilot project will investigate: 1) if curcumin can prevent or alleviate radiation-induced skin reactions in cancer patients receiving radiotherapy and 2) if skin pigmentation, as well as pain and psychophysiological factors, can predict the severity of radiation-induced dermatitis. Potential future research studies may be conducted to identify the biological mechanisms involved in radiation-induced dermatitis and the radioprotective function of curcumin.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 35 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Curcumin for the Prevention of Radiation-induced Dermatitis in Breast Cancer Patients
• Study Start Date: January 2008
• Actual Primary Completion Date: September 2010
• Actual Study Completion Date: April 2011

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Curcumin C3 Complex; Patients take 2.0 grams curcumin (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (~4-7 weeks).	Drug: Curcumin C3 Complex; Patients take 2.0 grams curcumin (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (~4-7 weeks); Other Name: Curcumin; curcuminoids
Placebo Comparator: Placebo; Patients take 2.0 grams placebo (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (~4-7 weeks).	Drug: Placebo; Patients take 2.0 grams placebo (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (~4-7 weeks); Other Name: dicalcium phosphate with yellow food grade dye

Outcome Measures

Primary Outcome Measures :

1. Severity of Dermatitis in Radiation Treatment Site in Breast Cancer Patients [ Time Frame: 4-7 weeks (prescribed course of radiation) ]
   The severity of radiation dermatitis was measured using the Radiation Dermatitis Severity (RDS)Scale which ranges from 0.0 to 4.0 with increments of 0.5. The RDS scale is a revised form of the NIH Common Toxicity Criteria to account for color and subtle texture changes in the skin. The worst dermatitis (i.e., highest RDS score) at the end of treatment was used for the primary analysis of severity of radiation dermatitis in each treatment group. Additionally, we performed repeated measure analyses to examine the severity of dermatitis over time in each arm.

Secondary Outcome Measures :

1. Moist Desquamation at Radiation Treatment Site [ Time Frame: 4-7 weeks (prescribed course of radiation) ]
   The presence of moist desquamation at the end of radiation treatment was examined between curcumin and placebo treatment groups. We compared the number of participants (or percentage) with moist desquamation between each treatment group.
2. Redness at Radiation Treatment Site [ Time Frame: 4-7 weeks (prescribed course of radiation) ]
   Redness at radiation treatment site was measured using a CR-400 Colorimeter (Konica Minolta). The colorimeter uses the L*a*b* color scale. We used a* values (redness) which range from 0.0 to 20.0. The lower the number value, the lower amount of redness. Therefore, high number values represent large amounts of redness.
3. Pain at Radiation Treatment Site [ Time Frame: 4-7 weeks (prescribed course of radiation) ]
   The McGill Pain Questionnaire-Short Form (MPQ-SF) was used to determine the participants pain at treatment site. The MPQ-SF contains three subscales: affective pain, sensory pain, and perceived pain. This outcome measure compared the total pain score (range 0 to 50)and subscale scores (sensory subscale range 0 to 33; affective subscale range 0 to 12; perceived pain subscale 0 to 5) at the end of radiation therapy between the two treatment arms.

Eligibility Criteria

• Ages Eligible for Study: 21 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Female with a diagnosis of, non-inflammatory breast adenocarcinoma and be referred for post-operative radiotherapy without concurrent chemotherapy.
• Participants must be at least 21 years of age.
• Participants must not be pregnant.
• Participants can be from any racial or ethnic origin.
• Breast adenocarcinoma could have been treated by either lumpectomy or mastectomy with or without adjuvant or neoadjuvant chemotherapy or hormonal treatment.
• Participants with in situ breast cancer are eligible.
• Participants who are prescribed concurrent hormone treatment with radiation treatment are eligible.
• Participants must be scheduled to receive five sessions of radiation therapy per week (1 session per day) for at least four weeks using standard (1.8-2.0 Gy per session)or Canadian (2.2-2.5 Gy per session)irradiation fractionation.
• A time period of three weeks must elapse after chemotherapy and surgery before beginning the study.
• The total dose prescribed to the whole breast should be 50 Gy or greater.
• Participants must be able to understand English and able to complete assessment forms (all assessment forms are in English).
• Participants must be able to swallow medication.
• Topical skin agents, e.g., Aquaphor, Cetaphil, or other emollients, are allowed either PRN or prophylactically.
• Participant must give informed consent.

Exclusion Criteria:

• Patients with bilateral breast cancer are not eligible.
• Patients who have had previous radiation therapy to the breast or chest are not eligible.
• Patients who are prescribed chemotherapy concurrently with radiation treatment are not eligible.
• Patients who will be receiving treatment with Herceptin (trastuzumab), anti-coagulants, or anti-human epidermal growth factor receptor (EGFR) drugs, e.g. Iressa (gefitinib), Erbitux (cetuximab, C225), concurrently with their radiation therapy are not eligible.
• Patients cannot have had breast reconstructions, implants, and/or expanders.
• Patients with known radiosensitivity syndromes (e.g., Ataxia-telangiectasia) are not eligible.
• Patients with collagen vascular disease, vasculitis, unhealed surgical sites, or breast infections are not eligible.
• Patients whose baseline blood tests meet the following criteria are not eligible: greater than or equal to Grade 2 change Hemoglobin (i.e., 25% decrease from baseline); greater than or equal to Grade 1 change in Platelets (i.e., less than 75,000/mm3); greater than or equal to Grade 2 change in PT and PTT(i.e., 1.5-2x upper level normal (ULN)); greater than or equal to Grade 1 change in AST, ALT (i.e., greater than 2.5x ULN); greater than or equal to Grade 1 change in Bilirubin (i.e., greater than 1.5x ULN); greater than or equal to Grade 1 change in Creatinine (i.e., greater than 2x ULN).

Contacts and Locations

Locations

United States, New York

University of Rochester Medical Center & Wilmot Cancer Center

Rochester, New York, United States, 14642

Sponsors and Collaborators

University of Rochester

Investigators

• Principal Investigator: Julie L Ryan, PhD, MPH; University of Rochester Medical Center & Wilmot Cancer Center
• Study Chair: Julie L Ryan, PhD, MPH; University of Rochester Medical Center & Wilmot Cancer Center
• Study Chair: Alice P Pentland, MD; University of Rochester Medical Center & Wilmot Cancer Center
• Study Chair: Marilyn Ling, MD; University of Rochester Medical Center & Wilmot Cancer Center

More Information

• Responsible Party: Julie Ryan, Assistant Professor, University of Rochester
• ClinicalTrials.gov Identifier: NCT01042938
• Other Study ID Numbers: URCC1106; 5KL2RR024136-03 ( U.S. NIH Grant/Contract ); 05-238-80 ( Other Grant/Funding Number: Dermatology Foundation )
• First Posted: January 6, 2010
• Results First Posted: June 20, 2012
• Last Update Posted: June 25, 2012
• Last Verified: June 2012

Keywords provided by Julie Ryan, University of Rochester:

Radiation dermatitis in breast cancer patients

Additional relevant MeSH terms:

Breast Neoplasms; Dermatitis; Radiodermatitis; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Radiation Injuries; Wounds and Injuries; Curcumin; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antirheumatic Agents; Antineoplastic Agents; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action