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Trial Title:
The Effect of Ganoderma on Patients With Head-and-neck Cancer
NCT ID:
NCT02238587
Condition:
Head-and-neck Cancer
Conditions: Official terms:
Head and Neck Neoplasms
Conditions: Keywords:
Gandoerma Spores Powder Capsules, head-and-neck cancer.
Study type:
Interventional
Study phase:
N/A
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Crossover Assignment
Masking:
Double (Participant, Outcomes Assessor)
Intervention:
Intervention type:
Other
Intervention name:
Control group
Description:
In control group, only placebos are given for 6 weeks. The patients who are in control
groups are switched to receive Ganoderma Spores Powder Capsules for 6 weeks.
Arm group label:
Placebo/Ganoderma
Intervention type:
Dietary Supplement
Intervention name:
Ganoderma Spores Powder Capsules
Description:
In experimental group, Ganoderma Spores Powder Capsules for 12 weeks.
Arm group label:
Ganoderma
Arm group label:
Placebo/Ganoderma
Summary:
To study the effect of Ganoderma Spores Powder Capsules on the life quality and immunity
status of the patients with head-and-neck cancer after complete treatment (including
surgery and / or radiotherapy and/or chemotherapy)
Detailed description:
Ganoderma is known to modulate immunity and improve health. However, the mechanism is not
clear. We hypothesize that patients who have completed standard treatment with/without
radiotherapy might require biological modifier such as Ganoderma to improve life quality
and immunity status.
A total of 100 patients are randomized to study and control groups. In study group,
Ganoderma Spores Powder Capsules are given to the patients for 6 weeks, In control group,
only placebos are given during the same period. Then the patients in study and control
groups are switched, Ganoderma Spores Powder Capsules and placebos are given for 6 weeks.
The data pertaining to their Life quality are collected using Quality of Life
Questionnaire after the first 6 weeks and the second 6 weeks. The immunity status is also
studied at the same time.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patients with head-and-neck cancer after complete treatment for at least 3 months
(including surgery and/or radiotherapy and/or chemotherapy)
Exclusion Criteria:
- Patients with head-and-neck cancer under treatment or within 3 months after
treatment
Gender:
All
Minimum age:
20 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Division of Core Laboratory; Chang Bing Show Chwan Memorial Hospital
Address:
City:
Changhua County
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Kuender D. Yang, PhD
Phone:
886-975617006
Email:
yangkd.yeh@hotmail.com
Start date:
June 2014
Completion date:
May 2015
Lead sponsor:
Agency:
Chang Bing Show Chwan Memorial Hospital
Agency class:
Other
Source:
Chang Bing Show Chwan Memorial Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT02238587
