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Wheatgrass Juice / Lifestyle Recommendations / Cancer Patients' Quality of Life / Chemotherapy Treatment (4001)

This study is currently recruiting participants.
Verified December 2012 by Carmel Medical Center
Sponsor:
Information provided by (Responsible Party):
Eran Ben-Arie, Carmel Medical Center
ClinicalTrials.gov Identifier:
NCT01215448
First received: September 28, 2010
Last updated: December 31, 2012
Last verified: December 2012
History of Changes
  Purpose

This study is aimed to study the impact of wheatgrass juice and lifestyle recommendations (diet, physical activity and breathing exercises) on the well being, fatigue and hematological parameters of chemotherapy-naive patients with no evidence for symptoms of active oncological disease.The researchers hypothesize that both wheatgrass juice and lifestyle recommendations can improve patient's well-being during chemotherapy.


Condition Intervention
Fatigue
 Dietary Supplement: Wheatgrass juice

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Impact of Wheatgrass Juice and Lifestyle Recommendations on Cancer Patients' Quality of Life During Chemotherapy Treatment

Resource links provided by NLM:

MedlinePlus related topics: Cancer Fatigue
U.S. FDA Resources

Further study details as provided by Carmel Medical Center:

Primary Outcome Measures:
  • Assessing impact of wheatgrass juice and lifestyle recommendations on cancer patients' quality of life [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Assessing impact of wheatgrass juice and lifestyle recommendations on cancer patients' quality of life(including fatigue)during chemotherapy


Secondary Outcome Measures:
  • Assessing compliance of patients to lifestyle recommendations during chemotherapy [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Assessing compliance of patients to lifestyle recommendations (diet, physical activity and breathing exercises) during chemotherapy


Estimated Enrollment: 60
Study Start Date: October 2010
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Lifestyle changes
Lifestyle changes(booklet and audio cassette of recommended diet, physical activity and breathing exercises)
Experimental: Wheatgrass juice & lifestyle changes
Wheatgrass juice & lifestyle changes
 Dietary Supplement: Wheatgrass juice
110 CC daily od frozen wheatgrass juice in the intervention arm
Other Name: Triticum aestivum

Detailed Description:

Chemotherapy-naive patients will be offered to participate in a two arms study. Following consent, patients will be randomized to one of two arms. Patients in both arms will be provided by booklet and audio-cassette that specify lifestyle recommendations (diet, physical activity and breathing exercises). Patients in one of the study arms will be provided in addition with frozen wheatgrass juice (recommended daily dosage of 55-110 CC daily). Patients in both arms will be asked to fill in a daily patient's diary monitoring the practice of the lifestyle recommendations.

Baseline assessment will include the following questionnaires: ESAS, MYCAW, FACIT- Fatigue. Evaluation will include weekly ESAS and FACIT-Fatigue questionnaire and subsequent evaluation (including ESAS, MYCAW, FACIT- Fatigue questionnaires) following 3 and 4 chemotherapy cycles of treatment. Follow-up evaluation will be performed at the completion of chemotherapy.

  Eligibility

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of cancer with no sign of active disease
  • First-time treatment with chemotherapy

Exclusion Criteria:

  • Treatment with per os administration of chemotherapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01215448

Contacts
Contact: Eran Ben-Arye, MD 972-528709282 eranbe@clalit.org.il
Contact: Mali Azencot, MA 97252667645 maliaz@clalit.org

Locations
Israel
Lin Medical Center Recruiting
Haifa, Israel
Contact: Eran Ben-Arye, MD     9724528709282     eranbe@clalit.org.il    
Principal Investigator: Eran Ben Arye, Dr            
Sponsors and Collaborators
Carmel Medical Center
Investigators
Principal Investigator: Eran Ben-Arye, MD Clalait Health Services
  More Information

Publications:

Responsible Party: Eran Ben-Arie, integrative Oncology Program, Medical director, The Oncology Service and Lin Medical center, Clalit Health Services., Carmel Medical Center
ClinicalTrials.gov Identifier: NCT01215448     History of Changes
Other Study ID Numbers: CMC-10-0054-CTIL
Study First Received: September 28, 2010
Last Updated: December 31, 2012
Health Authority: Israel: Ethics Commission

Keywords provided by Carmel Medical Center:
Fatigue
Quality of life
Lifestyle
Complementary medicine

Additional relevant MeSH terms:
Fatigue
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013