NCT01215448

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2010

Completed
3 days until next milestone

Study Start

First participant enrolled

October 1, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 6, 2010

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

June 17, 2014

Status Verified

June 1, 2014

Enrollment Period

2.8 years

First QC Date

September 28, 2010

Last Update Submit

June 16, 2014

Conditions

Keywords

FatigueQuality of lifeLifestyleComplementary medicine

Outcome Measures

Primary Outcomes (1)

  • 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

    4 months

Secondary Outcomes (1)

  • Assessing compliance of patients to lifestyle recommendations during chemotherapy

    4 months

Study Arms (2)

Lifestyle changes

NO INTERVENTION

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

Wheatgrass juice & lifestyle changes

EXPERIMENTAL

Wheatgrass juice \& lifestyle changes

Dietary Supplement: Wheatgrass juice

Interventions

Wheatgrass juiceDIETARY_SUPPLEMENT

110 CC daily od frozen wheatgrass juice in the intervention arm

Also known as: Triticum aestivum
Wheatgrass juice & lifestyle changes

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Treatment with per os administration of chemotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lin Medical Center

Haifa, Israel

Location

Related Publications (1)

  • 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.

    PMID: 17571966BACKGROUND

MeSH Terms

Conditions

Fatigue

Interventions

Flour

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Eran Ben-Arye, MD

    Clalait Health Services

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
integrative Oncology Program, Medical director, The Oncology Service and Lin Medical center, Clalit Health Services.

Study Record Dates

First Submitted

September 28, 2010

First Posted

October 6, 2010

Study Start

October 1, 2010

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

June 17, 2014

Record last verified: 2014-06

Locations