Trental & Vitamin E for Radiation-Induced Fibrosis

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-02-28

Study Completion Date

2012-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study seeks to determine if a combination of Trental and Vitamin E prevents the development of radiation fibrosis in women treated with radiation for the definitive management of their breast cancer.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Pentoxiphylline and Vitamin E Versus Vitamin E in Patients With Non- Alcoholic Steatohepatitis

NCT01384578

Non Alcoholic Steatohepatitis

WITHDRAWN PHASE3

Isoflavones in Treating Women Who Have Breast Cancer and Are Planning to Undergo Mastectomy or Lumpectomy

NCT00036686

Breast Cancer

TERMINATED NA

Macrobiotic Diet and Flax Seed: Effects on Estrogens, Phytoestrogens, & Fibrinolytic Factors

NCT00010829

Cardiovascular Diseases Osteoporosis Breast Cancer +1 more

COMPLETED PHASE2

Exploring Mechanism of Action of Dietary Fibre on the Gut Microbiota and Metabolites

NCT05906589

Psyllium Inulin

RECRUITING NA

Nutraceuticals Versus Usual Care in the Prevention or Reduction of CIPN in Patients Treated With Docetaxel as Neoadjuvant/Adjuvant Breast Cancer Therapy

NCT02795572

Peripheral Neuropathy in Breast Cancer Patient

TERMINATED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Radiation fibrosis occurs in approximately 25% of those women treated with radiation for breast cancer. Of these, approximately 3 to 5% will develop into an acute, painful form of fibrosis. Mild fibrosis can present as a thicker or more dense breast where the acute form can cause pain in the breast, significant hardening, and inflammation.

Treatments for fibrosis are lacking, with the primary treatment being hyperbaric oxygen therapy. The combination of Trental \& Vitamin E has been used with success in Europe and at the University of Iowa.

The focus of this study is to prevent fibrosis through intervention with Trental \& Vitamin E. The study has two arms, a control arm and an intervention arm. The study is not blinded. Measurements are taken at standard follow-up visits to measure breast density and lymphedema.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Fibrosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Control for study - watchful waiting.

Group Type NO_INTERVENTION

No interventions assigned to this group

2

Combined treatment with Pentoxifylline and Vitamin E.

Group Type EXPERIMENTAL

Pentoxifylline

Intervention Type DRUG

Pentoxifylline 400 mg, 3 times daily for 7 months, beginning immediately after radiation therapy.

Vitamin E

Intervention Type DRUG

Vitamin E (Over-the-counter) 400 I.U. once daily

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Pentoxifylline

Pentoxifylline 400 mg, 3 times daily for 7 months, beginning immediately after radiation therapy.

Intervention Type DRUG

Vitamin E

Vitamin E (Over-the-counter) 400 I.U. once daily

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Trental

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients with histologically documented cancer of the breast or DCIS or head and neck referred for definitive radiation with curative intent.
* No evidence of metastatic disease.
* Minimum life expectancy of at least 12 months.
* Aged greater than 20 years.
* If female, pregnancy excluded.
* No documented history of collagen vascular disease.

Exclusion Criteria

* Cognitively impaired patients
* Prisoners
* No histology available
* Documented metastatic disease
* Allergy to Trental
* Life expectance of less than 12 months.
* Aged less than 20 years
* Collagen vascular disease present
* Pregnant
* History of liver disease
* Use of anticoagulants

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No