Pentoxifylline and vitamin E treatment for prevention of radiation induced side effects in women with breast cancer

ISRCTN	ISRCTN39143623
DOI	https://doi.org/10.1186/ISRCTN39143623
Protocol serial number	Ptx-5
Sponsor	Lund University Hospital (Sweden)
Funder	Swedish Cancer Society (Cancerfonden) (Sweden) (ref: 4981-B05-02XBC)

Submission date: 11/10/2007
Registration date: 30/10/2007
Last edited: 06/07/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Eliabeth Kjellen
Scientific

Department of Oncology
Lund University Hospital
Lund
SE 221 85
Sweden

Phone	+46 (0)46 176661
Email	elisabeth.kjellen@med.lu.se

Study information

Primary study design	Interventional
Study design	The trial is randomised, single centre, placebo controlled, double-blinded, with a parallel study design. Randomisation is stratified for previous cytostatic treatment
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	Ptx-5
Study objectives	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(s)	Ethics approval received from Lund University Ethics Committee on the 8th December 2003 (ref: LU758-03).
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	10/05/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	80
Key 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
Key exclusion criteria	1. Known sensitivity to pentoxifylline or vitamin E 2. Disorders related to muscles or joints 3. Corticosteroid treatment during radiotherapy treatment
Date of first enrolment	13/05/2004
Date of final enrolment	10/05/2012

Locations

Countries of recruitment

Sweden

Study participating centre

Department of Oncology

Lund
SE 221 85
Sweden

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/09/2009		Yes	No