Breast NeoplasmsPhase 2NCT00188669
The Use of Pentoxifylline and Vitamin E in the Treatment of Chronic Breast Pain
A Phase 2 study testing pentoxifylline and alpha-Tocopherol in people with Breast Neoplasms, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
An estimated 20 - 45 % of women treated with breast conserving treatment experience chronic pain in the treated breast. The aetiology of this is poorly understood. Some of these women have signs of chronic radiation mastitis. There is no accepted treatment for this condition. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- pentoxifylline and alpha-Tocopherol
- How many people
- 48 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2002to not given
- Phase
- Phase 2
- 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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- UICC TNM stage 0 (i.e. in situ disease), 1 or 2 breast cancer patients treated with conservative surgery and adjuvant radiotherapy with chronic breast pain or tenderness, with or without fibrosis, within 3 months to 3 years following completion of radiotherapy
- Age 18 to 75 years of age
- Chronic symptoms localised to the breast treated with radiation, i.e. any one or more of the following- pain (not attributable to infection) or tenderness with or without associated oedema, fibrosis, necrosis or ulceration.
- Breast pain (maximum in the previous 24 hours) measurable on a Linear Analogue Scale with a length of 3cm or greater
- Prior treatment with radiation to the affected area i.e. in tangential breast fields or boost area
- Radiation completed at least 3 months and no longer than 3 years prior to study entry
- Informed consent
Who cannot join
- Active cellulitis in the breast
- Active malignant disease
- Any medical illness or condition judged likely by the local investigator to preclude safe administration of protocol treatment
- Contraindication to treatment with pentoxifylline (i.e. previously exhibited intolerance to pentoxifylline or other xanthines such as caffeine, theophylline or theobromine; recent cerebral and/or retinal haemorrhage; ischaemic heart disease; hypotension
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Study of the Use of Pentoxifylline and a-Tocopherol in the Treatment of Chronic Breast Pain Associated With Breast Radiotherapy
An estimated 20 - 45 % of women treated with breast conserving treatment experience chronic pain in the treated breast. The aetiology of this is poorly understood. Some of these women have signs of chronic radiation mastitis. There is no accepted treatment for this condition. The combination of pentoxifylline and vitamin E has been shown to be effective in reversing radiation fibrosis in this region. Many of these patients have had a benefit in pain response in a time period of a few benefits. This study is a phase II study of these drugs for a 6 month trial period to assess the effect on chronic breast pain in breast cancer patients who are 3 months to 3 years post radiation treatment.
- Conditions
- Breast Neoplasms
- Being tested
- pentoxifylline, alpha-Tocopherol
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pentoxifyllineDrug
alpha-TocopherolDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess improvement in breast pain with use of the interventional agents.
To assess improvement in patient function with the use of the interventional agents.
Secondary outcomes (4)
To assess time to maximal improvement in pain, durability of response, quality of life changes during the study
To qualitatively characterise presenting pain syndromes
To examine techniques for objective assessment of breast edema and texture/fibrotic changes
To investigate the feasibility of the use of high resolution (40MHz) ultrasound and whether changes can be measured
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startJul 2002
Why it stopped: date: August 2006. No annual renewal
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Princess Margaret Hospital, Canada
- Investigators
- Wilfred Levin, MD, Principal investigator, Princess Margaret Hospital, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00188669
- Sponsor's protocol ID
- UNH REB 02-0137-C
- Status last verified
- Aug 2010
- First submitted
- 12 Sep 2005
- Last updated
- 11 Aug 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of the Use of Pentoxifylline and a-Tocopherol in the Treatment of Chronic Breast Pain Associated With Breast Radiotherapy
- ClinicalTrials.gov ID
- NCT00188669
- Acronym / sponsor ID
- UNH REB 02-0137-C
- Conditions
- Breast Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: date: August 2006. No annual renewal
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Princess Margaret Hospital, Canada
- Study start
- Jul 2002
- First posted
- 16 Sep 2005 (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.
An estimated 20 - 45 % of women treated with breast conserving treatment experience chronic pain in the treated breast. The aetiology of this is poorly understood. Some of these women have signs of chronic radiation mastitis. There is no accepted treatment for this condition. The combination of pentoxifylline and vitamin E has been shown to be effective in reversing radiation fibrosis in this region. Many of these patients have had a benefit in pain response in a time period of a few benefits. This study is a phase II study of these drugs for a 6 month trial period to assess the effect on chronic breast pain in breast cancer patients who are 3 months to 3 years post radiation treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- UICC TNM stage 0 (i.e. in situ disease), 1 or 2 breast cancer patients treated with conservative surgery and adjuvant radiotherapy with chronic breast pain or tenderness, with or without fibrosis, within 3 months to 3 years following completion of radiotherapy
- Age 18 to 75 years of age
- Chronic symptoms localised to the breast treated with radiation, i.e. any one or more of the following- pain (not attributable to infection) or tenderness with or without associated oedema, fibrosis, necrosis or ulceration.
- Breast pain (maximum in the previous 24 hours) measurable on a Linear Analogue Scale with a length of 3cm or greater
- Prior treatment with radiation to the affected area i.e. in tangential breast fields or boost area
Key exclusion criteria (5 listed)
- Active cellulitis in the breast
- Active malignant disease
- Any medical illness or condition judged likely by the local investigator to preclude safe administration of protocol treatment
- Contraindication to treatment with pentoxifylline (i.e. previously exhibited intolerance to pentoxifylline or other xanthines such as caffeine, theophylline or theobromine; recent cerebral and/or retinal haemorrhage; ischaemic heart disease; hypotension
- Pregnant or lactating women
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 |
|---|---|---|
| pentoxifylline | Drug | – |
| alpha-Tocopherol | Drug | – |
Primary outcome
To assess improvement in breast pain with use of the interventional agents.
To assess improvement in patient function with the use of the interventional agents.
4 secondary outcomes
To assess time to maximal improvement in pain, durability of response, quality of life changes during the study
To qualitatively characterise presenting pain syndromes
To examine techniques for objective assessment of breast edema and texture/fibrotic changes
To investigate the feasibility of the use of high resolution (40MHz) ultrasound and whether changes can be measured
Results and safety
The study was stopped early (reason given: date: August 2006. No annual renewal). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2010.
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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.
Wilfred Levin, MD principal investigator
Princess Margaret Hospital, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing pentoxifylline and alpha-Tocopherol in people with Breast Neoplasms, run by University Health Network, Toronto at 1 site in Canada.
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 5 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: stopped early, as of the sponsor's last update on 11 Aug 2010. 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 Canada. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: date: August 2006. No annual renewal). Results are not available in the source record.
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?
To assess improvement in breast pain with use of the interventional agents.. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Aug 2010.