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

June 16, 2014 updated by: Eran Ben-Arye, Carmel Medical Center

Impact of Wheatgrass Juice and Lifestyle Recommendations on Cancer Patients' Quality of Life During Chemotherapy Treatment

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Haifa, Israel
        • Lin Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 91 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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
Dietary supplement: Wheatgrass juice
110 CC daily od frozen wheatgrass juice in the intervention arm
Other Names:
  • Triticum aestivum

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Carmel Medical Center

Investigators

  • Principal Investigator: Eran Ben-Arye, MD, Clalait Health Services

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

September 28, 2010

First Submitted That Met QC Criteria

October 5, 2010

First Posted (Estimate)

October 6, 2010

Study Record Updates

Last Update Posted (Estimate)

June 17, 2014

Last Update Submitted That Met QC Criteria

June 16, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMC-10-0054-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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