Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01215448
Recruitment Status : Completed
First Posted : October 6, 2010
Last Update Posted : June 17, 2014
Sponsor:
Information provided by (Responsible Party):
Eran Ben-Arye, Carmel Medical Center

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease Intervention/treatment Phase
Fatigue Dietary Supplement: Wheatgrass juice Not Applicable

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.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Impact of Wheatgrass Juice and Lifestyle Recommendations on Cancer Patients' Quality of Life During Chemotherapy Treatment
Study Start Date : October 2010
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Assessing impact of wheatgrass juice and lifestyle recommendations on cancer patients' quality of life [ Time Frame: 4 months ]
    Assessing impact of wheatgrass juice and lifestyle recommendations on cancer patients' quality of life(including fatigue)during chemotherapy


Secondary Outcome Measures :
  1. Assessing compliance of patients to lifestyle recommendations during chemotherapy [ Time Frame: 4 months ]
    Assessing compliance of patients to lifestyle recommendations (diet, physical activity and breathing exercises) during chemotherapy


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01215448


Locations
Layout table for location information
Israel
Lin Medical Center
Haifa, Israel
Sponsors and Collaborators
Carmel Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Eran Ben-Arye, MD Clalait Health Services
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Layout table for additonal information
Responsible Party: Eran Ben-Arye, integrative Oncology Program, Medical director, The Oncology Service and Lin Medical center, Clalit Health Services., Carmel Medical Center
ClinicalTrials.gov Identifier: NCT01215448    
Other Study ID Numbers: CMC-10-0054-CTIL
First Posted: October 6, 2010    Key Record Dates
Last Update Posted: June 17, 2014
Last Verified: June 2014
Keywords provided by Eran Ben-Arye, Carmel Medical Center:
Fatigue
Quality of life
Lifestyle
Complementary medicine
Additional relevant MeSH terms:
Layout table for MeSH terms
Fatigue