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

Primary Purpose

Fatigue

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Wheatgrass juice
Sponsored by
Carmel Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Fatigue focused on measuring Fatigue, Quality of life, Lifestyle, Complementary medicine

Eligibility Criteria

18 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Lin Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Lifestyle changes

Wheatgrass juice & lifestyle changes

Arm Description

Lifestyle changes(booklet and audio cassette of recommended diet, physical activity and breathing exercises)

Wheatgrass juice & lifestyle changes

Outcomes

Primary Outcome Measures

Assessing impact of wheatgrass juice and lifestyle recommendations on cancer patients' quality of life
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
Assessing compliance of patients to lifestyle recommendations (diet, physical activity and breathing exercises) during chemotherapy

Full Information

First Posted
September 28, 2010
Last Updated
June 16, 2014
Sponsor
Carmel Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01215448
Brief Title
Wheatgrass Juice / Lifestyle Recommendations / Cancer Patients' Quality of Life / Chemotherapy Treatment
Acronym
4001
Official Title
Impact of Wheatgrass Juice and Lifestyle Recommendations on Cancer Patients' Quality of Life During Chemotherapy Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Carmel Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatigue
Keywords
Fatigue, Quality of life, Lifestyle, Complementary medicine

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lifestyle changes
Arm Type
No Intervention
Arm Description
Lifestyle changes(booklet and audio cassette of recommended diet, physical activity and breathing exercises)
Arm Title
Wheatgrass juice & lifestyle changes
Arm Type
Experimental
Arm Description
Wheatgrass juice & lifestyle changes
Intervention Type
Dietary Supplement
Intervention Name(s)
Wheatgrass juice
Other Intervention Name(s)
Triticum aestivum
Intervention Description
110 CC daily od frozen wheatgrass juice in the intervention arm
Primary Outcome Measure Information:
Title
Assessing impact of wheatgrass juice and lifestyle recommendations on cancer patients' quality of life
Description
Assessing impact of wheatgrass juice and lifestyle recommendations on cancer patients' quality of life(including fatigue)during chemotherapy
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Assessing compliance of patients to lifestyle recommendations during chemotherapy
Description
Assessing compliance of patients to lifestyle recommendations (diet, physical activity and breathing exercises) during chemotherapy
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eran Ben-Arye, MD
Organizational Affiliation
Clalait Health Services
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lin Medical Center
City
Haifa
Country
Israel

12. IPD Sharing Statement

Citations:
PubMed Identifier
17571966
Citation
Bar-Sela G, Tsalic M, Fried G, Goldberg H. Wheat grass juice may improve hematological toxicity related to chemotherapy in breast cancer patients: a pilot study. Nutr Cancer. 2007;58(1):43-8. doi: 10.1080/01635580701308083.
Results Reference
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Wheatgrass Juice / Lifestyle Recommendations / Cancer Patients' Quality of Life / Chemotherapy Treatment

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