Double-blind, placebo-controlled, randomised phase 2 trial of IH636 grape seed proanthocyanidin (GSPE) in patients with adverse effects of high dose breast radiotherapy

ISRCTN ISRCTN72553848
DOI https://doi.org/10.1186/ISRCTN72553848
Secondary identifying numbers RMH1991
Submission date
15/10/2002
Registration date
15/10/2002
Last edited
05/01/2016
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

http://cancerhelp.cancerresearchuk.org/trials/using-ih636-grape-seed-extract-to-reduce-side-effects-of-high-dose-radiotherapy-for-breast-cancer

Contact information

Dr - -
Scientific

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

Study information

Study designDouble-blind placebo-controlled randomised study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleDouble-blind, placebo-controlled, randomised phase 2 trial of IH636 grape seed proanthocyanidin (GSPE) in patients with adverse effects of high dose breast radiotherapy
Study objectivesNot provided at time of registration
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedBreast cancer
InterventionIH636 grape seed proanthocyanidin extract (100 mg) or placebo TDS for 6 months
Intervention typeDrug
Pharmaceutical study type(s)
PhasePhase II
Drug / device / biological / vaccine name(s)IH636 grape seed proanthocyanidin (GSPE)
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/01/2001
Completion date10/10/2002

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexFemale
Target number of participantsNot provided at time of registration
Key inclusion criteria1. 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
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/01/2001
Date of final enrolment10/10/2002

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom

Sponsor information

The Royal Marsden NHS Foundation Trust (UK)
Hospital/treatment centre

Downs Road
Sutton
SM2 5PT
England
United Kingdom

ROR logo https://ror.org/0008wzh48

Funders

Funder type

Research organisation

Royal Marsden Hospital (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/04/2006 Yes No
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