Condition category
Cancer
Date applied
15/10/2002
Date assigned
15/10/2002
Last edited
05/01/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr - -

ORCID ID

Contact details

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

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 measures

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

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

Sponsor information

Organisation

The Royal Marsden NHS Foundation Trust (UK)

Sponsor details

Downs Road
Sutton
SM2 5PT
United Kingdom

Sponsor type

Hospital/treatment centre

Website

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

Results - basic reporting

Publication summary

2006 results in: http://www.ncbi.nlm.nih.gov/pubmed/16546280

Publication citations

Additional files

Editorial Notes