Back to results

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

Primary Purpose

Breast Cancer

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Curcumin C3 Complex

Placebo

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Radiation dermatitis in breast cancer patients

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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).

Sites / Locations

University of Rochester Medical Center & Wilmot Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Curcumin C3 Complex

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Moist Desquamation at Radiation Treatment Site

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.

Redness at Radiation Treatment Site

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.

Pain at Radiation Treatment Site

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.

Full Information

NCT ID

NCT01042938

First Posted

January 4, 2010

Last Updated

June 19, 2012

Sponsor

University of Rochester

1. Study Identification

Unique Protocol Identification Number

NCT01042938

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2012

Overall Recruitment Status

Completed

Study Start Date

January 2008 (undefined)

Primary Completion Date

September 2010 (Actual)

Study Completion Date

April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Rochester

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

Radiation dermatitis in breast cancer patients

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

35 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Curcumin C3 Complex

Arm Type

Active Comparator

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Curcumin C3 Complex

Other Intervention Name(s)

Curcumin; curcuminoids

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

dicalcium phosphate with yellow food grade dye

Intervention Description

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

Primary Outcome Measure Information:

Title

Severity of Dermatitis in Radiation Treatment Site in Breast Cancer Patients

Description

Time Frame

4-7 weeks (prescribed course of radiation)

Secondary Outcome Measure Information:

Title

Moist Desquamation at Radiation Treatment Site

Description

Time Frame

4-7 weeks (prescribed course of radiation)

Title

Redness at Radiation Treatment Site

Description

Time Frame

4-7 weeks (prescribed course of radiation)

Title

Pain at Radiation Treatment Site

Description

Time Frame

4-7 weeks (prescribed course of radiation)

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility 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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Julie L Ryan, PhD, MPH

Organizational Affiliation