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OpenTrials
Completed

NCT Number: NCT01506466

Weight Variation During Chemotherapy in Breast Cancer Patients

Weight variation has been reported as a side effect of chemotherapy treatment in early breast cancer patients. To date, there is growing evidence for an increased risk of relapse and death in these patients who gain or lose weight. However, causes of weight variation during chemotherapy and mechanisms involved in the poor prognosis have been little studied.

Thus, the investigators are conducting a prospective study to characterize weight variation in terms of body composition and to identify the mechanisms involved.

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Key information

Conditions

Breast Cancer Body Weight Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

Up to 70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Centre Jean Perrin

Clermont-Ferrand, 63000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • menopausal women
  • breast cancer
  • patients requiring chemotherapy treatment
  • WHO performance status 0-2

Exclusion criteria

  • diabetics
  • patients with metastases
  • other cancer

Treatment and study plan

blood test/ additional measurement

Other

blood test (hormonal, inflammatory, lipid and growth factors); body composition measurements; energy balance evaluation

Primary outcomes

  1. Change from baseline in body composition

    Time frame: within 2 weeks before chemotherapy; 1month after the last chemotherapy; and 6 months later.

Secondary outcomes

  1. Change from baseline in energy balance

    Time frame: within 2 weeks before chemotherapy; 1month after the last chemotherapy; and 6 months later.

    resting energy expenditure, physical activity, food records.

  2. Change from baseline in muscle strength

    Time frame: within 2 weeks before chemotherapy; 1month after the last chemotherapy; and 6 months later.

  3. Change from baseline in biological factors (hormonal, inflammatory, lipid, growth factors)

    Time frame: within 2 weeks before chemotherapy; 1month after the last chemotherapy; and 6 months later.

Sponsors and collaborators

Lead sponsor

Centre Jean Perrin

Other

Registry information

Official study title

Weight Variation and Mechanisms Involved, During Chemotherapy in Breast Cancer Patients

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Jan 10, 2012
Registry last updated
Jul 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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