We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01215448
First Posted: October 6, 2010
Last Update Posted: June 17, 2014
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.
Information provided by (Responsible Party):
Eran Ben-Arye, Carmel Medical Center
  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
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

Resource links provided by NLM:


Further study details as provided by Eran Ben-Arye, Carmel Medical Center:

Primary Outcome Measures:
  • 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:
  • 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


Enrollment: 17
Study Start Date: October 2010
Study Completion Date: August 2013
Primary Completion Date: August 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

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.


Ages Eligible for Study:   18 Years to 95 Years   (Adult, Senior)
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
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
Israel
Lin Medical Center
Haifa, Israel
Sponsors and Collaborators
Carmel Medical Center
Investigators
Principal Investigator: Eran Ben-Arye, MD Clalait Health Services
  More Information

Publications:
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     History of Changes
Other Study ID Numbers: CMC-10-0054-CTIL
First Submitted: September 28, 2010
First Posted: October 6, 2010
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:
Fatigue
Signs and Symptoms