Plain English Summary
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RMH1991
Study information
Scientific title
Double-blind, placebo-controlled, randomised phase 2 trial of IH636 grape seed proanthocyanidin (GSPE) in patients with adverse effects of high dose breast radiotherapy
Acronym
Study hypothesis
Not provided at time of registration
Ethics approval
Not provided at time of registration
Study design
Double-blind placebo-controlled randomised study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Breast cancer
Intervention
IH636 grape seed proanthocyanidin extract (100 mg) or placebo TDS for 6 months
Intervention type
Drug
Phase
Phase II
Drug names
IH636 grape seed proanthocyanidin (GSPE)
Primary outcome measure
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/2001
Overall trial end date
10/10/2002
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Past history of early breast cancer (T1-3 N0-1 M0)
2. Past history of radiotherapy to the breast
3. A minimum of 24 months post radiotherapy
4. No evidence of cancer recurrence
5. Palpable breast induration due to previous radiotherapy
6. Ability to attend The Royal Marsden Hospital, Sutton for assessments
7. Written informed consent
Participant type
Patient
Age group
Not Specified
Gender
Female
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/01/2001
Recruitment end date
10/10/2002
Locations
Countries of recruitment
United Kingdom
Trial participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
Funders
Funder type
Research organisation
Funder name
Royal Marsden Hospital (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
Basic results (scientific)
Publication list
2006 results in: http://www.ncbi.nlm.nih.gov/pubmed/16546280