Supplementation With Dietary Anthocyanins and Side Effects of Radiotherapy for Breast Cancer

NCT02195960 | Completed

• 1 other identifier: Neuromed-ATH-EU2014
• Study Type: interventional
• Target: 242
• Locations: 1 country
• Sites: 1

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.

Conditions

Toxicity Due to Radiotherapy

Keywords

skin toxicity, radiotherapy, antioxidants

Outcome Measures

Primary Outcomes (1)

• side effects of radiotherapy

  Prevention of side effects - skin toxicity - of radiotherapy

  4 or 6 weeks, according to the radiotherapy protocol

Secondary Outcomes (3)

• Acute skin toxicity

  1 month after the end of treatment (8 or 10 weeks)

• Peripheral markers of inflammation

  before starting treatment, at the end (4 or 6 weeks) and 1 month after radiotherapy (8 or 10 weeks)

• Peripheral markers of bioavailability

  before starting and at the end of treatment (4 or 6 weeks)

Other Outcomes (1)

• long-term skin toxicity

  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

Study Arms (2)

placebo

PLACEBO COMPARATOR

intake corn extract poor in anthocyanins: three daily stick packs containing water-soluble extract from corn cobs poor in anthocyanins

Dietary Supplement: Placebo

intake anthocyanin-rich corn extract

ACTIVE COMPARATOR

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

Interventions

Placebo DIETARY_SUPPLEMENT

intake corn extract poor in anthocyanins: three daily stick packs containing water-soluble extract from corn cobs poor in anthocyanins

placebo

intake anthocyanin-rich corn extract DIETARY_SUPPLEMENT

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

intake anthocyanin-rich corn extract

Eligibility Criteria

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

You may qualify if:

• The patient must consent to be in the study and must have signed an approved consent form conforming with institutional guidelines.
• Patients must be ≥ 18 years old.
• On histological examination, the tumor must be DCIS or invasive carcinoma of the breast.
• 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.
• 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.)
• 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.
• 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.

You may not qualify if:

• Axillary nodes with definite evidence of microscopic or macroscopic extracapsular extension.
• One or more positive non-axillary sentinel node(s). (Note that intramammary nodes are staged as axillary nodes.)
• 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.
• Suspicious microcalcifications, densities, or palpable abnormalities (in the ipsilateral or contralateral breast) unless biopsied and found to be benign.
• Non-epithelial breast malignancies such as sarcoma or lymphoma.
• Proven multicentric carcinoma (invasive cancer or DCIS) in more than one quadrant or separated by 4 or more centimeters.
• Paget's disease of the nipple.
• Synchronous bilateral invasive or non-invasive breast cancer.
• 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.)
• Breast implants. (Patients who have had implants removed are eligible.)
• Prior breast or thoracic radiation therapy for any condition.
• Collagen vascular disease, specifically dermatomyositis with a creatine phosphokinase level above normal or with an active skin rash, systemic lupus erythematosus, or scleroderma.
• 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.
• Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements.

Sponsors & Collaborators

• Neuromed IRCCS: lead

Study Sites (1)

Department of Radiotherapy

Campobasso, CB, 86100, Italy

Location

Related Publications (1)

• Bracone F, De Curtis A, Di Castelnuovo A, Pilu R, Boccardi M, Cilla S, Macchia G, Deodato F, Costanzo S, Iacoviello L, de Gaetano G, Morganti AG, Petroni K, Tonelli C, Donati MB, Cerletti C; EU-ATHENA Trial Investigators. Skin toxicity following radiotherapy in patients with breast carcinoma: is anthocyanin supplementation beneficial? Clin Nutr. 2021 Apr;40(4):2068-2077. doi: 10.1016/j.clnu.2020.09.030. Epub 2020 Oct 6.

  PMID: 33051045 DERIVED

Study Officials

• Maria Benedetta Donati, MD PhD

  Neuromed IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patients, doctors, RT technicians, investigators and statisticians who participated or evaluated the study outcomes were blinded to the nature of the supplements. Anthocyanin and placebo stick packs and soluble granulated products were identical for organoleptic properties and coded as A and B by the producer. Only after completion of statistical analyses of trial results, blind codes were opened by the provider.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: head laboratory

Model Details: Corn cobs-derived extracts of soluble anthocyanins given to breast cancer patients undergoing radiotherapy, to test prevention of skin toxicity.

Study Record Dates

• First Submitted: June 3, 2014
• First Posted: July 21, 2014
• Study Start: June 9, 2014
• Primary Completion: June 26, 2017
• Study Completion: October 10, 2018
• Last Updated: January 27, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)