Toxicity Due to RadiotherapyATHENANCT02195960
Supplementation With Dietary Anthocyanins and Side Effects of Radiotherapy for Breast Cancer
A study testing intake anthocyanin-rich corn extract in people with Toxicity Due to Radiotherapy, run by Neuromed IRCCS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Toxicity Due to Radiotherapy
- What is being tested?
- intake anthocyanin-rich corn extract
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 242 participants
- Where
- 1 siteItaly
- Study dates
- 9 Jun 2014to 10 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Detailed Description
- 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.
- 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.
- 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).
- 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.
- Conditions
- Toxicity Due to Radiotherapy
- Being tested
- Placebo, intake anthocyanin-rich corn extract
- Keywords
- skin toxicity, radiotherapy, antioxidants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
intake corn extract poor in anthocyanins: three daily stick packs containing water-soluble extract from corn cobs poor in anthocyanins
intake anthocyanin-rich corn extractDietary supplement
intake anthocyanin-rich corn extract: three daily stick packs containing water-soluble extract from high-anthocyanin rich corn cobs
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | intake corn extract poor in anthocyanins: three daily stick packs containing water-soluble extract from corn cobs poor in anthocyanins Receives: 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 Receives: Dietary Supplement: intake anthocyanin-rich corn extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
side effects of radiotherapy
Prevention of side effects - skin toxicity - of radiotherapy
Measured: 4 or 6 weeks, according to the radiotherapy protocol
Secondary outcomes (3)
Acute skin toxicity
Secondary end-points are late toxicity, cosmetic results, local control, and survival.
Measured: 1 month after the end of treatment (8 or 10 weeks)
Peripheral markers of inflammation
Blood cells count, markers of plasma and cell oxidation, markers of inflammatory response and oxidative DNA damage
Measured: before starting treatment, at the end (4 or 6 weeks) and 1 month after radiotherapy (8 or 10 weeks)
Peripheral markers of bioavailability
Anthocyanins excretion will be evaluated in urine samples by analytical techniques.
Measured: before starting and at the end of treatment (4 or 6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2014 (estimated)
- Study start9 Jun 2014
- Primary completion26 Jun 2017
- Study completion10 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Toxicity Due to RadiotherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Corn cobs-derived extracts of soluble anthocyanins given to breast cancer patients undergoing radiotherapy, to test prevention of skin toxicity.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neuromed IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Benedetta Donati, Neuromed IRCCS
- Investigators
- Maria Benedetta Donati, MD PhD, Principal investigator, Neuromed IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02195960
- Sponsor's protocol ID
- Neuromed-ATH-EU2014
- Acronym
- ATHENA
- Status last verified
- Jan 2021
- First submitted
- 3 Jun 2014
- Last updated
- 27 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 33051045
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supplementation With Dietary Anthocyanins and Side Effects of Radiotherapy for Breast Cancer
- ClinicalTrials.gov ID
- NCT02195960
- Acronym / sponsor ID
- ATHENA / Neuromed-ATH-EU2014
- Conditions
- Toxicity Due to Radiotherapy
- Keywords
- skin toxicity, radiotherapy, antioxidants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- Neuromed IRCCSUniversity, hospital or other
- Study start
- 9 Jun 2014 (actual)
- Primary completion
- 26 Jun 2017 (actual)
- Study completion
- 10 Oct 2018 (actual)
- First posted
- 21 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Detailed Description
- 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.
- 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.
- 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).
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Corn cobs-derived extracts of soluble anthocyanins given to breast cancer patients undergoing radiotherapy, to test prevention of skin toxicity.
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Dietary Supplement: Placebointake corn extract poor in anthocyanins: three daily stick packs containing water-soluble extract from corn cobs poor in anthocyanins |
| intake anthocyanin-rich corn extract | Active comparator | Dietary Supplement: intake anthocyanin-rich corn extractintake anthocyanin-rich corn extract: three daily stick packs containing water-soluble extract from high-anthocyanin rich corn cobs |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.)
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebointake 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 extractintake 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 |
Primary outcome
side effects of radiotherapy
Time frame: 4 or 6 weeks, according to the radiotherapy protocol
Prevention of side effects - skin toxicity - of radiotherapy
3 secondary outcomes
Acute skin toxicity
Time frame: 1 month after the end of treatment (8 or 10 weeks)
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)
Peripheral markers of bioavailability
Time frame: before starting and at the end of treatment (4 or 6 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2021.
- Derived from this study: PubMed 33051045Bracone 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Benedetta Donati, MD PhD principal investigator
Neuromed IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intake anthocyanin-rich corn extract in people with Toxicity Due to Radiotherapy, run by Neuromed IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
side effects of radiotherapy (time frame: 4 or 6 weeks, according to the radiotherapy protocol). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02195960, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2021.