Breast CancerPhase 2NCT00022204
Vitamin E and Pentoxifylline in Treating Women With Lymphedema After Radiation Therapy for Breast Cancer
A Phase 2 study testing vitamin E, pentoxifylline and quality-of-life assessment in people with Breast Cancer and Lymphedema, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
RATIONALE: Vitamin E and pentoxifylline may be effective in decreasing lymphedema in women who have received radiation therapy for breast cancer. PURPOSE: Randomized phase II trial to determine the effectiveness of combining vitamin E and pentoxifylline in treating women who have lymphedema after receiving radiation… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Breast Cancer, Lymphedema
- What is being tested?
- vitamin E, pentoxifylline and quality-of-life assessment
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2000to 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS: Prior diagnosis of breast cancer T1-3, N0-1, M0 Prior radiotherapy to breast/chest wall plus axilla and/or supraclavicular fossa At least 2 years since prior radiotherapy No disease recurrence Arm lymphedema due to prior radiotherapy Reduced shoulder movement, induration in breast/chest wall, radiation-induced brachial plexopathy, symptomatic lung fibrosis, or non-healing wounds (including fractures) allowed as evidence of disability in addition to arm lymphedema Hormone receptor status: Not specified
PATIENT CHARACTERISTICS: Age: Not specified Sex: Female or male Menopausal status: Not specified Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: No liver failure Renal: No renal failure Cardiovascular: No ischemic heart disease No hypertension No hypotension No acute myocardial infarction No prior cerebral hemorrhage No prior retinal hemorrhage Other: Not pregnant Negative pregnancy test Fertile patients must use effective contraception No allergy to coconut oil
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: No concurrent insulin Radiotherapy: See Disease Characteristics Surgery: No prior axillary surgery Lower axillary sampling allowed Other: At least 3 months since prior daily vitamin E supplementation of more than 30 mg/day No prior pentoxifylline after radiotherapy No concurrent ketorolac or vitamin K No other concurrent vitamin E supplementation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double-Blind, Placebo-Controlled, Randomised Trial Of Alpha-Tocopherol And Oxpentifylline In Patients With Radiation Fibrosis
RATIONALE: Vitamin E and pentoxifylline may be effective in decreasing lymphedema in women who have received radiation therapy for breast cancer.
PURPOSE: Randomized phase II trial to determine the effectiveness of combining vitamin E and pentoxifylline in treating women who have lymphedema after receiving radiation therapy for breast cancer.
Read the detailed description
OBJECTIVES: I. Determine the effects of vitamin E and pentoxifylline on lymphedema in patients previously treated with radiotherapy for breast cancer. II. Compare the normal tissue injury and quality of life in patients treated with this regimen vs placebo.
OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are randomized to one of two treatment arms. Arm I: Patients receive oral vitamin E and oral pentoxifylline twice daily for 6 months. Arm II: Patients receive oral placebo twice daily for 6 months. Quality of life is assessed at baseline and at 3, 6, 9, and 12 months. Patients are followed at 6 and 12 months.
PROJECTED ACCRUAL: A total of 100 patients (50 per treatment arm) will be accrued for this study.
- Conditions
- Breast Cancer, Lymphedema
- Being tested
- vitamin E, pentoxifylline, quality-of-life assessment
- Keywords
- stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, lymphedema, male breast cancer
- Medical subject headings
- Breast Neoplasms, Lymphedema, Breast Neoplasms, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitamin EDietary supplement
pentoxifyllineDrug
quality-of-life assessmentProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2004 (estimated)
- Study startJan 2000
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 Breast CancerStudies of the same condition, open and under way.
- More trials run by Royal Marsden NHS Foundation TrustThe 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
- Supportive care
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Investigators
- John R. Yarnold, MD, FRCR, Study chair, Royal Marsden NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00022204
- Sponsor's protocol ID
- CDR0000068794
- Other IDs
- RM-1597, EU-20050
- Status last verified
- May 2007
- First submitted
- 10 Aug 2001
- Last updated
- 6 Nov 2013
- Results posted
- No
Publications
Gothard L, Cornes P, Earl J, Hall E, MacLaren J, Mortimer P, Peacock J, Peckitt C, Woods M, Yarnold J. Double-blind placebo-controlled randomised trial of vitamin E and pentoxifylline in patients with chronic arm lymphoedema and fibrosis after surgery and radiotherapy for breast cancer. Radiother Oncol. 2004 Nov;73(2):133-9. doi: 10.1016/j.radonc.2004.09.013.
PubMed 15542159
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind, Placebo-Controlled, Randomised Trial Of Alpha-Tocopherol And Oxpentifylline In Patients With Radiation Fibrosis
- ClinicalTrials.gov ID
- NCT00022204
- Acronym / sponsor ID
- CDR0000068794
- Conditions
- Breast Cancer, Lymphedema
- Keywords
- stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, lymphedema, male breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Study start
- Jan 2000
- First posted
- 4 Feb 2004 (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.
RATIONALE: Vitamin E and pentoxifylline may be effective in decreasing lymphedema in women who have received radiation therapy for breast cancer.
PURPOSE: Randomized phase II trial to determine the effectiveness of combining vitamin E and pentoxifylline in treating women who have lymphedema after receiving radiation therapy for breast cancer.
Detailed description
OBJECTIVES: I. Determine the effects of vitamin E and pentoxifylline on lymphedema in patients previously treated with radiotherapy for breast cancer. II. Compare the normal tissue injury and quality of life in patients treated with this regimen vs placebo.
OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are randomized to one of two treatment arms. Arm I: Patients receive oral vitamin E and oral pentoxifylline twice daily for 6 months. Arm II: Patients receive oral placebo twice daily for 6 months. Quality of life is assessed at baseline and at 3, 6, 9, and 12 months. Patients are followed at 6 and 12 months.
PROJECTED ACCRUAL: A total of 100 patients (50 per treatment arm) will be accrued for this study.
Study design
- Primary purpose
- Supportive care
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| vitamin E | Dietary supplement | – |
| pentoxifylline | Drug | – |
| quality-of-life assessment | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
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 6 Nov 2013.
- Results publication: PubMed 15542159Gothard L, Cornes P, Earl J, Hall E, MacLaren J, Mortimer P, Peacock J, Peckitt C, Woods M, Yarnold J. Double-blind placebo-controlled randomised trial of vitamin E and pentoxifylline in patients with chronic arm lymphoedema and fibrosis after surgery and radiotherapy for breast cancer. Radiother Oncol. 2004 Nov;73(2):133-9. doi: 10.1016/j.radonc.2004.09.013.
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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.
John R. Yarnold, MD, FRCR study chair
Royal Marsden NHS Foundation Trust
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 vitamin E, pentoxifylline and quality-of-life assessment in people with Breast Cancer and Lymphedema, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2013. 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 United Kingdom. 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 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00022204, 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 6 Nov 2013.