Efficacy of an Oral Formula in Prevention of Anti-cancer Therapy Side Effects

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00455247

Enrollment

Unknown

Registered

2007-04-03

Start date

2007-10-31

Completion date

2012-01-31

Last updated

2013-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Digestive Cancers

Brief summary

Anti-cancer treatment is often inducing side-effects that can affect the compliance to the treatment protocol and quality of life of the patients. The researchers will study if the nutritional intervention with the product could abrogate the undesired effects in a preventive manner.

Interventions

DRUGGlutamine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patient with GI neoplasm * Patient that must start a (new) line of chemotherapy with at least 2 cycles * Age \> 18 ans * Exclusively orally fed * Life expectancy more than 3 months * Intravenous 5FU-based chemotherapy with 2 or 3-week cycles * Hematological toxicities from previous chemotherapies terminated or \<= 2

Exclusion criteria

* Positive HIV status * Pregnant or lactating woman * Currently participating or having participated in another clinical trial during the last month prior to the beginning of this study * Patient having diarrhoea of grade \> 1 for more than 2 weeks before the inclusion * State of sub occlusion, chronic inflammatory diseases of the digestive tract, radiation enteropathy * Sepsis * Concomitant radiotherapy, except analgesic radiotherapy

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026