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

NCT01042938 | Completed Phase 2 Results DMC

• 3 other identifiers: URCC11065KL2RR024136-0305-238-80
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Radiation dermatitis in breast cancer patients

Outcome Measures

Primary Outcomes (1)

• Severity of Dermatitis in Radiation Treatment Site in Breast Cancer Patients

  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.

  4-7 weeks (prescribed course of radiation)

Secondary Outcomes (3)

• Moist Desquamation at Radiation Treatment Site

  4-7 weeks (prescribed course of radiation)

• Redness at Radiation Treatment Site

  4-7 weeks (prescribed course of radiation)

• Pain at Radiation Treatment Site

  4-7 weeks (prescribed course of radiation)

Study Arms (2)

Curcumin C3 Complex

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Curcumin C3 Complex DRUG

Patients take 2.0 grams curcumin (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (\~4-7 weeks)

Also known as: Curcumin; curcuminoids

Curcumin C3 Complex

Placebo DRUG

Patients take 2.0 grams placebo (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (\~4-7 weeks)

Also known as: dicalcium phosphate with yellow food grade dye

Placebo

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

University of Rochester Medical Center & Wilmot Cancer Center

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Curcumin; Diarylheptanoids; calcium phosphate, dibasic, dihydrate

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Limitations and Caveats

The primary limitation of this clinical study is the small sample size. This study was a pilot trial to generate an effect and sample size for a larger confirmatory trial. We accrued patients to this study until we had 30 fully evaluable patients.

Results Point of Contact

• Title: Julie L Ryan, PhD, MPH (PI)
• Organization: University of Rochester Medical Center

julie_ryan@urmc.rochester.edu

585-276-3862

Study Officials

• Julie L Ryan, PhD, MPH

  University of Rochester Medical Center & Wilmot Cancer Center

  PRINCIPAL INVESTIGATOR

• 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

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 4, 2010
• First Posted: January 6, 2010
• Study Start: January 1, 2008
• Primary Completion: September 1, 2010
• Study Completion: April 1, 2011
• Last Updated: June 25, 2012
• Results First Posted: June 20, 2012

Record last verified: 2012-06

Locations

US (1)