Condition category
Cancer
Date applied
11/10/2007
Date assigned
30/10/2007
Last edited
06/07/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Eliabeth Kjellen

ORCID ID

Contact details

Department of Oncology
Lund University Hospital
Lund
SE 221 85
Sweden
+46 (0)46 176661
elisabeth.kjellen@med.lu.se

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Ptx-5

Study information

Scientific title

Acronym

Ptx-5

Study hypothesis

Primary objective:
To investigate if pentoxifylline and vitamin E prevent radiation induced side effects measured as impaired shoulder mobility in women treated for breast cancer with radiotherapy to the axilla and breast.

Secondary objective:
To investigate if pentoxifylline and vitamin E prevent radiation-induced side effects measured as lymphoedema, and Late Effects Normal Tissue task force Subjective, Objective, Management, and Analytic (LENT-SOMA) breast score in women treated for breast cancer with radiotherapy to the axilla and breast.

Tertiary objective:
To investigate if pentoxifylline and vitamin E influence development of new Radiation-Induced Fibrosis (RIF) areas as measured with an impedance method and to investigate if pentoxifylline influence the plasma levels of Transforming Growth Factor-beta1 (TGF-beta1) in women treated for breast cancer with radiotherapy to the breast and axilla.

Ethics approval

Ethics approval received from Lund University Ethics Committee on the 8th December 2003 (ref: LU758-03).

Study design

The trial is randomised, single centre, placebo controlled, double-blinded, with a parallel study design. Randomisation is stratified for previous cytostatic treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Breast cancer

Intervention

Patients will be included in the study one month after termination of radiotherapy. At that time all other active cancer treatment will be finished, except for anti-hormone treatment with tamoxifen, letrozol, anastrozole and exemestane that are allowed as concomittant medication in this study.

During the first visit the patients will be assessed for eligibility and given a screening number. They will be informed about the study and the purpose of it. After giving their informed consent the subjects will undergo a physical examination, and their medical history will be obtained. The inclusion and exclusion criteria will be checked and then the subject will be randomised to a treatment group and given a patient number.

There are two treatment groups in the study. Both groups have the same number of patients:
Group A: treated with pentoxifylline and vitamin E
Group B: treated with placebo and vitamin E

Pentoxifylline/placebo will be escalated to 400 mg three times daily. The vitamin E dose will be 100 mg three times daily. The patients will be treated for 12 months.

Intervention type

Supplement

Phase

Not Specified

Drug names

Pentoxifylline, vitamin E

Primary outcome measures

Shoulder mobility is assessed by a goniometer; axillary movement will be analysed first time when all 80 patients have finished the first year of medication.

Secondary outcome measures

1. Lymphoedema, assessed by measurement of water displacement
2. LENT-SOMA breast score, assessed every 3 months during the year of medication, twice in year 2 and yearly for 3 years up to 5 years
3. Impedance measurement of RIF areas
4. Plasma TGF-beta1 levels, analysed as a separate part of the study when patients have been included for 1 year

Secondary endpoint will be analysed (blinded) after one year of medication. All patients will be followed for 5 years and the final analysis will be done when all patients have been followed for 5 years.

Overall trial start date

13/05/2004

Overall trial end date

10/05/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Women (no age limit) with breast cancer
2. Treated with axillary dissection, mastectomy or segmental resection of the breast, and radiotherapy to the breast and axilla
3. All active cancer treatment is terminated, except for anti-hormone treatment with tamoxifen, letrozol, anastrozole, and exemestane
4. Able to understand the nature of the trial and give written informed consent

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

80

Participant exclusion criteria

1. Known sensitivity to pentoxifylline or vitamin E
2. Disorders related to muscles or joints
3. Corticosteroid treatment during radiotherapy treatment

Recruitment start date

13/05/2004

Recruitment end date

10/05/2012

Locations

Countries of recruitment

Sweden

Trial participating centre

Department of Oncology
Lund
SE 221 85
Sweden

Sponsor information

Organisation

Lund University Hospital (Sweden)

Sponsor details

c/o Elisabeth Kjellen
Department of Oncology
Lund
SE 221 85
Sweden
+46 (0)46 176661
elisabeth.kjellen@med.lu.se

Sponsor type

Hospital/treatment centre

Website

http://www.med.lu.se/english

Funders

Funder type

Research organisation

Funder name

Swedish Cancer Society (Cancerfonden) (Sweden) (ref: 4981-B05-02XBC)

Alternative name(s)

Swedish Cancer Society

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Sweden

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19540105

Publication citations

  1. Results

    Magnusson M, Höglund P, Johansson K, Jönsson C, Killander F, Malmström P, Weddig A, Kjellén E, Pentoxifylline and vitamin E treatment for prevention of radiation-induced side-effects in women with breast cancer: a phase two, double-blind, placebo-controlled randomised clinical trial (Ptx-5)., Eur. J. Cancer, 2009, 45, 14, 2488-2495, doi: 10.1016/j.ejca.2009.05.015.

Additional files

Editorial Notes