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Trial record 1 of 1 for:    NCT02195960
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Supplementation With Dietary Anthocyanins and Side Effects of Radiotherapy for Breast Cancer (ATHENA)

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ClinicalTrials.gov Identifier: NCT02195960
Recruitment Status : Recruiting
First Posted : July 21, 2014
Last Update Posted : September 20, 2018
Sponsor:
Information provided by (Responsible Party):
Maria Benedetta Donati, Neuromed IRCCS

Brief Summary:

Attention has been focused recently on the development of modalities that can protect healthy organs from the harmful effects of radiation applied during different cancer treatment schedules. As radiation-induced DNA damage involves oxidative stress, the protective role of antioxidants has been tested in different dietary studies. Previous experience by the collaborative team of the principal investigator and radiotherapists at the Catholic University of Campobasso has shown in a retrospective study that moderate wine consumption can reduce the side-effects of radiation therapy in patients with breast cancer. This effect was presumably due to the polyphenol non alcoholic fraction of wine, a finding in agreement with a cross-over intervention study in adult male volunteers, on protection by de-alcoholized red wine from ex vivo radiation-induced DNA damage.

The purpose of this clinical trial will be to test the impact of supplementation with anthocyanin-enriched food on the acute and medium-term side effects of radiotherapy in breast cancer patients, in a prospective study design. Therefore a double blind, randomised, placebo-controlled clinical trial will be organised by assigning patients with breast cancer scheduled for radiotherapy to a diet supplemented with an anthocyanin soluble extract.


Condition or disease Intervention/treatment Phase
Toxicity Due to Radiotherapy Dietary Supplement: Placebo Dietary Supplement: intake anthocyanin-rich corn extract Not Applicable

Detailed Description:

Detailed Description

  1. Study Rationale:

    Attention has been focused recently on the development of modalities that can protect healthy organs from the harmful effects of radiation applied during different cancer treatment schedules. As radiation-induced DNA and cellular damage involve oxidative stress, the protective role of antioxidants will be tested on the toxic condition induced by radiotherapy in breast cancer treatment. Consumption of polyphenol-rich foods, such as fruits and vegetables, and beverages derived from plants, such as cocoa, red wine and tea, may represent a beneficial diet in terms of oxidative protection. Indeed, a retrospective study reports that that moderate wine consumption can reduce the side-effects of radiation therapy in patients with breast cancer. This effect was presumably due to the polyphenol non alcoholic fraction of wine, a finding in agreement with a cross-over intervention study in adult male volunteers, on protection by de-alcoholized red wine from ex vivo radiation-induced DNA damage. However, there are no studies that address the relationship of polyphenol-rich food consumption with the toxic effects of radiations in patients undergoing radiotherapy for breast cancer treatment.

  2. Aim of the study. The main objectives of this study are to evaluate the association between the effect of polyphenol-rich food supplementation and toxicity of radiotherapy for breast cancer.
  3. Study design: Randomized, placebo-controlled double-blind trial with 2 parallel arms: soluble corn flour at high content in anthocyanins and placebo. Placebo consists of soluble corn flour poor in anthocyanins. The treatment will start one week before starting radiotherapy, and continue during all radiotherapy treatment (of 3 or 5 weeks).
  4. Study Population and recruitment: A total of 300 consecutive breast cancer patients eligible for radiotherapy. Participants will be identified at the Department of Radiotherapy of the Giovanni Paolo II Foundation of Campobasso.

Eligible subjects will be recruited at their first consultation and subsequently referred to the research investigators. The research staff in charge of the recruitment will pre-screen participants on the basis of inclusion/exclusion criteria and will explain the study at this time.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Supplementation With Dietary Anthocyanins and Side Effects of Radiotherapy for Breast Cancer
Actual Study Start Date : June 2014
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: placebo
intake corn extract poor in anthocyanins: three daily stick packs containing water-soluble extract from corn cobs poor in anthocyanins
Dietary Supplement: Placebo
intake corn extract poor in anthocyanins: three daily stick packs containing water-soluble extract from corn cobs poor in anthocyanins

Active Comparator: intake anthocyanin-rich corn extract
intake anthocyanin-rich corn extract: three daily stick packs containing water-soluble extract from high-anthocyanin rich corn cobs
Dietary Supplement: intake anthocyanin-rich corn extract
intake anthocyanin-rich corn extract: three daily stick packs containing water-soluble extract from high-anthocyanin rich corn cobs




Primary Outcome Measures :
  1. side effects of radiotherapy [ Time Frame: 4 or 6 weeks, according to the radiotherapy protocol ]
    Prevention of side effects - skin toxicity - of radiotherapy


Secondary Outcome Measures :
  1. Acute skin toxicity [ Time Frame: 1 month after the end of treatment (8 or 10 weeks) ]
    Secondary end-points are late toxicity, cosmetic results, local control, and survival.

  2. Peripheral markers of inflammation [ Time Frame: before starting treatment, at the end (4 or 6 weeks) and 1 month after radiotherapy (8 or 10 weeks) ]
    Blood cells count, markers of plasma and cell oxidation, markers of inflammatory response and oxidative DNA damage

  3. Peripheral markers of bioavailability [ Time Frame: before starting and at the end of treatment (4 or 6 weeks) ]
    Anthocyanins excretion will be evaluated in urine samples by analytical techniques.


Other Outcome Measures:
  1. long-term skin toxicity [ Time Frame: 6 and 12 months after the end of radiotherapy, corresponding to 7 or 7.5 months and 13 or 13.5 months from the beginning of the study ]
    late toxicity, cosmetic results, local control, and survival



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The patient must consent to be in the study and must have signed an approved consent form conforming with institutional guidelines.
  2. Patients must be ≥ 18 years old.
  3. On histological examination, the tumor must be DCIS or invasive carcinoma of the breast.
  4. Surgical treatment of the breast must have been lumpectomy or quadrantectomy. The margins of the resected specimen must be histologically free of tumor (DCIS and invasive). Reexcision of surgical margins is permitted.
  5. Patients with invasive breast cancer are required to have axillary staging which can include sentinel node biopsy alone (if sentinel node is negative), sentinel node biopsy followed by axillary dissection or sampling with a minimum total of 6 axillary nodes (if sentinel node is positive), or axillary dissection alone (with a minimum of 6 axillary nodes). (Axillary staging is not required for patients with DCIS.)
  6. The patient must be randomized within 45 days following the last surgery for breast cancer (lumpectomy, re-excision of margins, or axillary staging procedure) or within 30 days following the last chemotherapy cycle.
  7. Patients with a history of non-breast malignancies are eligible if they have been disease-free for 5 or more years prior to randomization and are deemed by their physician to be at low risk for recurrence. Patients with the following cancers are eligible if diagnosed and treated within the past 5 years: carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinoma of the skin.

Exclusion Criteria:

  1. Axillary nodes with definite evidence of microscopic or macroscopic extracapsular extension.
  2. One or more positive non-axillary sentinel node(s). (Note that intramammary nodes are staged as axillary nodes.)
  3. Palpable or radiographically suspicious ipsilateral or contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes, unless there is histologic confirmation that these nodes are negative for tumor.
  4. Suspicious microcalcifications, densities, or palpable abnormalities (in the ipsilateral or contralateral breast) unless biopsied and found to be benign.
  5. Non-epithelial breast malignancies such as sarcoma or lymphoma.
  6. Proven multicentric carcinoma (invasive cancer or DCIS) in more than one quadrant or separated by 4 or more centimeters.
  7. Paget's disease of the nipple.
  8. Synchronous bilateral invasive or non-invasive breast cancer.
  9. Surgical margins that cannot be microscopically assessed or are positive at pathologic evaluation. (If surgical margins are rendered free of disease by reexcision, the patient is eligible.)
  10. Breast implants. (Patients who have had implants removed are eligible.)
  11. Prior breast or thoracic radiation therapy for any condition.
  12. Collagen vascular disease, specifically dermatomyositis with a creatine phosphokinase level above normal or with an active skin rash, systemic lupus erythematosus, or scleroderma.
  13. Pregnancy or lactation at the time of proposed randomization. Women of reproductive potential must agree to use an effective non-hormonal method of contraception during therapy.
  14. Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02195960


Contacts
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Contact: Chiara Cerletti, PhD +390865929663 chiara.cerletti@neuromed.it
Contact: Alessio Morganti, MD +390874312258 amorganti@rm.unicatt.it

Locations
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Italy
Department of Radiotherapy Recruiting
Campobasso, CB, Italy, 86100
Contact: Maria Benedetta Donati, MD, PhD       mbdonati@moli-sani.org   
Principal Investigator: Alessio Morganti, MD         
Sponsors and Collaborators
Neuromed IRCCS
Investigators
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Principal Investigator: Maria Benedetta Donati, MD PhD Neuromed IRCCS

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Responsible Party: Maria Benedetta Donati, head laboratory, Neuromed IRCCS
ClinicalTrials.gov Identifier: NCT02195960     History of Changes
Other Study ID Numbers: Neuromed-ATH-EU2014
First Posted: July 21, 2014    Key Record Dates
Last Update Posted: September 20, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Maria Benedetta Donati, Neuromed IRCCS:
skin toxicity, radiotherapy, antioxidants