Health TrialsbyHealthPanel

d-Limonene +Radiation +PlatinumBasedChemo for Xerostomia Prevention in LocallyAdvanced HNSCC

ConditionXerostomia
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorStanford University

About this trial

This study explores the safety of d-limonene, a commercially-available dietary supplement (food) as a potential therapeutic for the severe dry mouth (xerostomia) experienced by patients with head and neck cancer as a side effect of their anti-cancer treatment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically or cytologically confirmed diagnosis of advanced loco regional squamous cell carcinoma of the nasopharynx (AJCC v8 Stage II IV); oropharynx (AJCC v8 Stage I III for HPV+ cancer, excluding T1 2N0; AJCC v8 Stage III IV for Human papillomavirus (HPV) negative cancer); larynx (AJCC v8 Stage III to IV); or hypopharynx (AJCC v8 Stage III to IV), scheduled to undergo chemoradiation. Patients with squamous cell carcinoma of the head and neck from an unknown primary site with involved nodes (N1 to 3) also qualify.

Scheduled to received definitive RT with concurrent platinum based chemotherapy at Stanford

Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to 1

Must be able to swallow d limonene gelcaps at the time of enrollment.

Disqualifiers

History of allergic reactions attributed to citrus fruits

Pregnant or lactating

Trial design

Design model

Sequential

Treatments tested in this trial

  • D-Limonene Gelcaps

    Drug

    Administered orally at 2 to 8 grams daily

  • Intensity modulated radiotherapy (IMRT)

    Radiation

    Standard of Care -All patients will receive standard radiation treatment of 66 to 70 Gy given in 33 to 35 fractions (2 to 2.12 Gy/fractions) over 6.5 to 7 weeks.

  • Cisplatin

    Drug

    Standard of Care -Cisplatin as 100 mg/m2 IV

  • Xerostomia questionnaire

    Other intervention

    Xerostomia questionnaire consists of 4 items on dryness while eating/speaking and 4 on dryness at rest. Patients rate each symptom on an 11 point ordinal Likert scale from 0 to 10, with higher scores indicating greater xerostomia

Treatment groups

40 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Group A: d-limonene -2gramExperimental treatment 4 interventions
Group B: d-limonene -4gramExperimental treatment 4 interventions
Group C: d-limonene -6gramExperimental treatment 4 interventions
Group D: d-limonene -8gramExperimental treatment 4 interventions
Group E: de-escalation dose d-limonene -6gramExperimental treatment 4 interventions
Group F: de-escalation dose d-limonene -4gramExperimental treatment 4 interventions
Group G: de-escalation dose d-limonene -2gramExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Dose limiting Toxicity

Dose limiting toxicity is defined as d-limonene related toxicity causing: * Greater than 1 week delay in completing the radiation course. * Inability to receive ≥ 66 Gy of radiotherapy. * Inability to receive at least 200 mg/m2 of total cisplatin equivalent dose or a total area under the curve (AUC) of 10 for carboplatin equivalent dose due to toxicity related to d-limonene Grade 3 or higher diarrhea that is attributable to the study drug. * Grade 3 abdominal pain that is attributable to the study drug. The outcome will be reported as the number of participants per dose level who experience any DLT (a number without dispersion / variance).

Time frame
9 weeks

Secondary outcomes

1

Feasibility of adjuvant d-limonene administration

Participant compliance with adjuvant administration of d-limonene will be assessed as completing at least 14 weeks of per protocol adjuvant d-limonene treatment. The outcome is reported as the number of participants per dose level that were compliant.

Time frame
4 months
2

Xerostomia toxicity

The degree of xerostomia will be assessed by the xerostomia survey. The survey consists of 8 items: 4 items regarding dryness or discomfort while eating or chewing and 4 items regarding dryness and discomfort while not eating or chewing. The participant will rate each item on a Likert scale from 0 to 10 (least effect to most severe effect) with higher scores implying greater dryness or discomfort. A summary score is calculated by summing the scores for each item and linearly transforming the score to produce a final score on a scale from 0 to 100. The outcome is reported as the mean and standard deviation of the final transformed scores from all subjects with survey results, by treatment level.

Time frame
12 months post completion of chemoradiation

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Stanford University

Lead sponsor

National Institutes of Health (NIH)

Collaborator

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
Apply now